A Long-Term Safety and Tolerability Study of TV-46000 for Subcutaneous Use in Patients with Schizophrenia: A Phase 3, Randomized, Double-Blinded Clinical Trial.

BACKGROUND: TV-46000 is a long-acting subcutaneous antipsychotic (LASCA) formulation of risperidone that is approved by the United States Food and Drug Administration for the treatment of schizophrenia in adults. In the phase 3, randomized, double-blind RIsperidone Subcutaneous Extended-release (RISE) study, TV-46000 once monthly (q1m) and once every 2 months (q2m) significantly prolonged time to impending relapse compared with placebo [5.0-fold (q1m) and 2.7-fold (q2m)]. This phase 3, randomized, double-blind Safety in Humans of TV-46000 subcutaneous INjection Evaluation (SHINE) study was designed to evaluate the long-term safety, tolerability, and exposure of TV-46000 in schizophrenia. METHODS: Patients who completed RISE without relapse (rollover) or who were newly recruited (de novo) were eligible for the SHINE study. Patients were initially stabilized on oral risperidone for 12 weeks (completed in RISE for rollover, or in SHINE for de novo). Patients in the de novo cohort and patients who received placebo in RISE were randomized 1:1 in SHINE to receive TV-46000 q1m or q2m for up to 56 weeks. Primary endpoint for SHINE was frequency of reported adverse events (AEs); event rates [ER; events per 100 patient-years (PYs)] were calculated for each AE by patients upon general questioning. RESULTS: Overall, 336 patients were randomized in SHINE [TV-46000 q1m, n = 174; TV-46000 q2m, n = 162; of these, de novo, n = 109 and rollover, n = 227 (n = 172 patients were treated and n = 55 received placebo)]. A total of 334 patients were evaluated for safety [q1m, n = 172 (PY = 97.8); q2m, n = 162 (PY = 104.5)]. Proportions of patients (ER) with ≥ 1 AE and ≥ 1 treatment-related AE were 37% (180.0) and 21% (84.9) for TV-46000 q1m and 46% (157.9) and 20% (70.8) for TV-46000 q2m, respectively. Frequent treatment-related AEs [≥ 3% of patients in either group; proportion of patients (ER)] were injection site pain [q1m, 5% (24.5); q2m, 4% (22.0)] and injection site nodule [q1m, 2% (9.2); q2m, 6% (12.4)]. The proportions of patients with serious AEs was 5% for TV-46000 q1m and 7% for TV-46000 q2m; serious AEs reported for ≥ 2 patients overall were worsening schizophrenia [q1m, n = 1 (< 1%; ER, 1.02); q2m, n = 2 (1%; ER, 1.91)] and hyperglycemia [q1m, n = 1 (< 1%; ER, 1.02); q2m, n = 1 (< 1%; ER, 0.96)]. Of three reported deaths, none were related to treatment. Overall, eight patients discontinued treatment because of AEs. Similar or somewhat lower rates of AEs were reported for patients who rolled over from TV-46000 treatment compared with those who had no prior TV-46000 treatment (de novo and placebo rollover). Most AEs related to injection site reactions were mild; no patient had a severe reaction. CONCLUSION: Results from this long-term safety study add to the favorable safety profiles of TV-46000 q1m and q2m, consistent with other formulations of risperidone and previous studies with TV-46000. REGISTRATION: ClinicalTrials.gov, NCT03893825; 27 March 2019.

The United States Food and Drug Administration approved TV-46000 in April 2023 for the treatment of schizophrenia in adults. TV-46000 is a long-acting subcutaneous antipsychotic (LASCA) that uses technology that allows for the slow release of risperidone. TV-46000 is injected under the skin once monthly or once every 2 months. When people start taking TV-46000, they do not need an additional injection or oral risperidone. The Safety in Humans of TV-46000 subcutaneous INjection Evaluation (SHINE) was a clinical study in which patients with schizophrenia received TV-46000. SHINE was conducted in patients who completed the RIsperidone Subcutaneous Extended-release (RISE) study and new patients. All patients (TV-46000 once monthly, n = 162; TV-46000 once every 2 months, n = 172) received TV-46000 in SHINE to see whether safety results were the same long term compared with RISE. The proportions with more than one adverse event were 37% for TV-46000 once monthly and 46% for TV-46000 once every 2 months. The proportions with more than one adverse event related to treatment were 21% for TV-46000 once monthly and 20% for TV-46000 once every 2 months. Common adverse events related to treatment were injection site pain and small swelling. Serious adverse events were rare. None of the three reported deaths were related to treatment. Similar or lower rates of adverse events were reported for those who received TV-46000 in RISE compared with those with no prior TV-46000 treatment. The long-term safety results in SHINE were consistent with other forms of risperidone and previous studies with TV-46000.

Mechanomyography reflects the changes in oxygenated hemoglobin during electrically evoked cycling in individuals with spinal cord injury.

BACKGROUND: Functional electrical stimulation (FES) cycling has been reported to enhance muscle strength and improve muscle fatigue resistance after spinal cord injury (SCI). Despite its proposed benefits, the quantification of muscle fatigue during FES cycling remains poorly documented. This study sought to quantify the relationship between the vibrational performance of electrically-evoked muscles measured through mechanomyography (MMG) and its oxidative metabolism through near-infrared spectroscopy (NIRS) characteristics during FES cycling in fatiguing paralyzed muscles in individuals with SCI. METHODS: Six individuals with SCI participated in the study. They performed 30 min of FES cycling with MMG and NIRS sensors on their quadriceps throughout the cycling, and the signals were analyzed. RESULTS: A moderate negative correlation was found between MMG root mean square (RMS) and oxyhaemoglobin (O2Hb) [r = -0.38, p = 0.003], and between MMG RMS and total hemoglobin (tHb) saturation [r = -0.31, p = 0.017]. Statistically significant differences in MMG RMS, O2Hb, and tHb saturation occurred during pre- and post-fatigue of FES cycling (p < 0.05). CONCLUSIONS: MMG RMS was negatively associated with O2Hb and muscle oxygen derived from NIRS. MMG and NIRS sensors showed good inter-correlations, suggesting a promising use of MMG for characterizing metabolic fatigue at the muscle oxygenation level during FES cycling in individuals with SCI.

The Clinical Management of Electrical Stimulation Therapies in the Rehabilitation of Individuals with Spinal Cord Injuries.

Background: People with spinal cord injuries (SCIs) often have trouble remaining active because of paralysis. In the past, exercise recommendations focused on the non-paralyzed muscles in the arms, which provides limited benefits. However, recent studies show that electrical stimulation can help engage the paralyzed extremities, expanding the available muscle mass for exercise. Methods: The authors provide an evidence-based approach using expertise from diverse fields, supplemented by evidence from key studies toward the management of electrical stimulation therapies in individuals with SCIs. Literature searches were performed separately using the PubMed, Medline, and Google Scholar search engines. The keywords used for the searches included functional electrical stimulation cycling, hybrid cycling, neuromuscular electrical stimulation exercise, spinal cord injury, cardiovascular health, metabolic health, muscle strength, muscle mass, bone mass, upper limb treatment, diagnostic and prognostic use of functional electrical stimulation, tetraplegic hands, and hand deformities after SCI. The authors recently presented this information in a workshop at a major rehabilitation conference. Additional information beyond what was presented at the workshop was added for the writing of this paper. Results: Functional electrical stimulation (FES) cycling can improve aerobic fitness and reduce the risk of cardiovascular and metabolic diseases. The evidence indicates that while both FES leg cycling and neuromuscular electrical stimulation (NMES) resistance training can increase muscle strength and mass, NMES resistance training has been shown to be more effective for producing muscle hypertrophy in individual muscle groups. The response to the electrical stimulation of muscles can also help in the diagnosis and prognosis of hand dysfunction after tetraplegia. Conclusions: Electrical stimulation activities are safe and effective methods for exercise and testing for motor neuron lesions in individuals with SCIs and other paralytic or paretic conditions. They should be considered part of a comprehensive rehabilitation program in diagnosing, prognosing, and treating individuals with SCIs to improve function, physical activity, and overall health.

Exercise Responses During Outdoor Versus Virtual Reality Indoor Arm+FES-Leg Cycling in Individuals with Spinal Cord Injury.

Background: Virtual reality (VR)-enhanced indoor hybrid cycling in people with spinal cord injury (SCI) can be comparable to outdoor hybrid cycling. Method: Eight individuals with chronic thoracic-lesion SCI performed voluntary arm and electrically assisted leg cycling on a hybrid recumbent tricycle. Exercises were conducted outdoors and indoors incorporating VR technology in which the outdoor environment was simulated on a large flat screen monitor. Electrical stimulation was applied bilaterally to the leg muscle groups. Oxygen uptake (VO2), heart rate, energy expenditures, and Ratings of Perceived Exertion were measured over a 30-minute outdoor test course that was also VR-simulated indoors. Immediately after each exercise, participants completed questionnaires to document their perceptual-psychological responses. Results: Mean 30-minute VO2 was higher for indoor VR exercise (average VO2-indoor VR-exercise: 1316 ± mL/min vs. outdoor cycling: 1255 ± 53 mL/min; highest VO2-indoor VR-exercise: 1615 ± 67 mL/min vs. outdoor cycling: 1725 ± 67 mL/min). Arm and leg activity counts were significantly higher during indoor VR-assisted hybrid functional electrical stimulation (FES) cycling than outdoors; 42% greater for the arms and 23% higher for the legs (P < 0.05). Similar responses were reported for exercise effort and perceptual-psychological outcomes during both modes. Conclusion: This study proposes that combining FES and VR technology provides new opportunities for physical activity promotion or exercise rehabilitation in the SCI population, since these modes have similar "dose-potency" and self-perceived effort. Human Research Ethics Committee of the University of Sydney Ref. No. 01-2010/12385.

Activity-Based Therapy for Mobility, Function and Quality of Life after Spinal Cord Injuries-A Mixed-Methods Case Series.

(1) Background: Despite inconclusive evidence on the benefits of activity-based therapies (ABTs) in people with spinal cord injuries, implementation has occurred in clinics worldwide in response to consumers' requests. We explored the clinical changes and participants' perceptions from engaging in an ABT program in the community. (2) Methods: This mixed-methods study involved a pragmatic observational multiple-baseline design and an evaluation of participants' perceptions. Fifteen participants were included. Outcome measures were balance in sitting using the Seated Reach Distance test, mobility using the Modified Rivermead Mobility Index and quality of life using the Quality of Life Index SCI version pre- and post-participation in an ABT community-based program. Linear mixed models and logistic regressions were used to analyse the effects of intervention. Semi-structured interviews explored participants' perceptions using inductive thematic analysis. (3) Results: There was an increase of 9% in the standardised reach distance (95% CI 2-16) for sitting balance, 1.33 points (95% CI: 0.81-1.85) in mobility and 1.9 points (0.17-2.1) in quality of life. Two themes emerged from the interviews: (1) reduced impact of disability and an increased sense of life as before, and (2) the program was superior to usual rehabilitation. No adverse events related to the intervention were observed. (4) Conclusion: ABT delivered in the community improved clinical outcomes in people with a chronic SCI. High levels of satisfaction with the program were reported.

Heart Rate Variability Biofeedback in Adults with a Spinal Cord Injury: A Laboratory Framework and Case Series.

Heart rate variability biofeedback (HRV-F) is a neurocardiac self-regulation therapy that aims to regulate cardiac autonomic nervous system activity and improve cardiac balance. Despite benefits in various clinical populations, no study has reported the effects of HRV-F in adults with a spinal cord injury (SCI). This article provides an overview of a neuropsychophysiological laboratory framework and reports the impact of an HRV-F training program on two adults with chronic SCI (T1 AIS A and T3 AIS C) with different degrees of remaining cardiac autonomic function. The HRV-F intervention involved 10 weeks of face-to-face and telehealth sessions with daily HRV-F home practice. Physiological (HRV, blood pressure variability (BPV), baroreflex sensitivity (BRS)), and self-reported assessments (Fatigue Severity Scale, Generalised Anxiety Disorder Scale, Patient Health Questionnaire, Appraisal of Disability and Participation Scale, EuroQol Visual Analogue Scale) were conducted at baseline and 10 weeks. Participants also completed weekly diaries capturing mood, anxiety, pain, sleep quality, fatigue, and adverse events. Results showed some improvement in HRV, BPV, and BRS. Additionally, participants self-reported some improvements in mood, fatigue, pain, quality of life, and self-perception. A 10-week HRV-F intervention was feasible in two participants with chronic SCI, warranting further investigation into its autonomic and psychosocial effects.

Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria.

BACKGROUND: TV-46000 is a long-acting, subcutaneous, antipsychotic agent that combines risperidone and an innovative, copolymer-based drug delivery technology in a suspension that was approved in April, 2023 for subcutaneous use. The aim of the phase 3 Risperidone Subcutaneous Extended-release (RISE) study was to evaluate the efficacy of TV­46000 in schizophrenia. METHODS: The RISE study consisted of two treatment stages: a 12-week, open-label stabilisation phase with oral risperidone (stage 1), and an open-ended, randomised, double-blind, placebo-controlled, relapse-prevention phase with subcutaneous TV-46000 (stage 2) done at 69 clinical sites across the USA and Bulgaria. Patients diagnosed with schizophrenia more than 1 year before screening by DSM-5 criteria and confirmed at screening by the Structured Clinical Interview for DSM-5 and who had at least one relapse within 24 months before screening were eligible for enrolment. Patients who were outpatients and stabilised in stage 1 continued to stage 2 and were randomly assigned 1:1:1 by a computer-generated randomisation list to receive either subcutaneous TV-46000 once monthly, TV-46000 once every 2 months, or placebo until relapse, early discontinuation, or the study was stopped because the prespecified stopping criterion of at least 90 relapse events was met. The primary endpoint was time to impending relapse of the intention-to-treat patient population in stage 2. This study is registered with ClinicalTrials.gov, number NCT03503318, and is complete. FINDINGS: The study enrolled the first patient on June 1, 2018, and the last patient completed on Dec 3, 2020. 1267 patients were screened, 863 enrolled, and 544 (male, n=332 [61%], female, n=212 [39%]; mean [SD] age, 49·3 [10·98] years; Black or African American, n=322 [59%]; White, n=206 [38%]; Asian, n=7 [1%]; Native Hawaiian or other Pacific Islander, n=2 [<1%]; race not reported, n=3 [<1%]; other race, n=4 [<1%]; Hispanic or Latinx, n=117 [22%]) randomly assigned to subcutaneous TV-46000 once monthly (n=183), TV-46000 once every 2 months (n=180), or placebo (n=181). Time to impending relapse was significantly prolonged by 5·0 times with TV-46000 once monthly (hazard ratio, 0·200 [95% CI 0·109-0·367]; p<0·0001) and by 2·7 times with TV-46000 once every 2 months (0·375 [0·227-0·618]; p<0·0001) versus placebo. Most frequently reported treatment-related adverse events (ie, ≥5% of patients in either TV-46000 group) that occurred more often in patients receiving TV-46000 (once monthly or once every 2 months) versus placebo were injection site nodules (7% for TV-46000 once monthly, 7% for TV-46000 once every 2 months, 3% for placebo), weight increased (4%, 6%, 2%, respectively), and extrapyramidal disorder (5%, 3%, 0% respectively). Serious adverse events were reported for eight (4%) patients in the TV-46000 once-monthly group, ten (6%) patients in the TV-46000 once-every-2-months group, and 14 (8%) patients in the placebo group. The safety profile of TV-46000 was consistent with other approved formulations of risperidone. No new safety signals were identified. INTERPRETATION: In patients with schizophrenia, subcutaneous TV-46000 once monthly and once every 2 months significantly delayed impending relapse versus placebo. TV-46000 is an effective long-acting, subcutaneous, antipsychotic agent treatment option in adult patients with schizophrenia, with a favourable benefit-risk profile. FUNDING: Teva Branded Pharmaceutical Products R&D.

Translation, cross-cultural adaptation and reliability testing of the barriers to physical activity and Disability survey (B-PADS) for Thai people with Spinal Cord injury.

PURPOSE: The objectives of this study were to translate and culturally adapt the Barriers to Physical Activity and Disability Survey (B-PADS) into the Thai context and to assess its inter- and intra-rater reliability. METHODS: Participants were experts in the field of spinal cord injury (SCI, n = 3), linguistic experts (n = 7), Thai-English bilingual speakers (n = 40), Thai physiotherapists (n = 8), and people with SCI living in Thailand (n = 43). The translation and cross-cultural adaptation of the B-PADS into the Thai context was conducted using a 6-step process; forward translation, reconciliation of the two translated versions, backward-translation, harmonisation, backward-translation of the revised version, and cognitive debriefing with potential users and target population. The reliability of the translated tool was assessed using Cohen's kappa (K) and McNemar's test. RESULTS: The inter-rater reliability test demonstrated high-range agreement for the majority of statements (27 out of 38; Cohen's K > 0.60) in the Thai-B-PADS final version. The intra-rater reliability test revealed that the majority of the statements (29 out of 38) in the Thai-B-PADS final version obtained substantial (Cohen's K = 0.61-0.80, p < 0.05) to perfect agreement (Cohen's K = 1.0, p < 0.05). McNemar's test displayed no statistically significant differences amongst assessors (p > 0.05) for nearly all statements. CONCLUSION: The Thai-B-PADS final version was successfully translated and culturally adapted for people with SCI.

Multi-stakeholders, including academic experts, researchers, translators, clinicians, target users and clients, should be involved in developing health-related questionnaires' translation and cultural adaptation processes.The Thai version of Barriers to Physical Activity and Disability Survey (B-PADS) possessed high levels of inter- and intra-rater reliability to assess barriers related to undertaking physical activities or exercise in people with spinal cord injury.Interactional biases and perceived social status effects may not be avoided when deploying a face-to-face interview of health-related questionnaires in a culture where social hierarchy is present within the language.The translation and adaptation processes used in this study were thorough, systematic and comprehensive, providing a culturally competent exemplar for translating health-related questionnaires between languages of different root origins.

Effects of behaviour change interventions on physical activity in people with spinal cord injury: A systematic review and meta-analysis.

OBJECTIVES: This review investigated the effectiveness of behaviour-change interventions to improve physical activity (PA) participation in individuals with a spinal cord injury. Additionally, the review sought to analyse the change in PA behaviour that might be expected by utilising behaviour change in PA interventions and what specific intervention characteristics, application of behaviour change theories, and behaviour change techniques are most efficacious. METHODS: The protocol was prospectively registered on PROSPERO: CRD42021252744, and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed in this review. Eight databases were comprehensively searched using a well-defined strategy developed in collaboration with an academic liaison librarian. Randomised, non-randomised controlled, and non-controlled studies were included in this review; however, controlled and non-controlled studies were analysed separately. Studies were included if participants were older than 16 years and had an SCI of any cause, level or severity, regardless of the time since injury. The behaviour change technique taxonomy version 1 was used to code the intervention characteristics for behaviour modification. The combined effects across studies were pooled in a meta-analysis, and the risk of bias was assessed using the Cochrane Risk of Bias 2 tool. RESULTS: The search retrieved 10,155 titles and abstracts. After duplicate removal and screening against the eligibility criteria, 23 studies were included. The overall effect estimate of the change in PA participation in the controlled trials post-intervention was medium (d = 0.50, 95% CI = 0.31-0.70) in favour of behaviour-targeted interventions. The mean difference in PA volume between pre- and post-intervention was an increase of 22 minutes per week (95% CI = 5.96-38.90). Interventions that provided practical support (d = 0.81, 95% CI = 0.46-1.16), which were individualised (d = 0.62, 95% CI = 0.34-0.90) and that utilised monitoring (d = 0.59, 95% CI = 0.34-0.83) had a greater effect on change to PA than those that were group-based and did not utilise those specific techniques. CONCLUSIONS: Interventions that target behaviour change to increase PA in people with SCI appear effective. Utilising behaviour change frameworks and specific behaviour change techniques augments PA uptake and levels, and interventions aimed at improving PA in people with SCI should incorporate a behaviour modification component. More research is needed on the isolated effect of intervention structure parameters and specific behaviour change techniques.

Effects of a combined progressive resistance training and functional electrical stimulation-evoked cycling exercise on lower limb muscle strength of individuals with incomplete spinal cord injury: A randomized controlled study.

Objectives: This study was conducted to investigate the effects of combined progressive resistance training (PRT) and functional electrical stimulation-evoked leg cycling exercise (FES-LCE) on isometric peak torque and muscle volume in individuals with incomplete spinal cord injury. Patients and methods: In the single-blind, randomized controlled trial performed between April 2015 and August 2016, 28 participants were randomized between two exercise interventions (FES-LCE+PRT and FES-LCE alone), and training was conducted over 12 weeks. The isometric muscle peak torque and muscle volume for both lower limbs were measured at the baseline and after 6 and 12 weeks. Linear mixed-model analysis of variance was performed to test the effects of FES-LCE+PRT versus FES-LCE on each outcome measure over time via an intention-to-treat analysis. Results: Twenty-three participants (18 males, 5 females; mean age: 33.4±9.7 years; range 21 to 50 years) completed study (10 in the FES-LCE+PRT group, and 13 in the FES-LCE group). The 12-week pre-and posttraining change for left hamstrings' muscle peak torque in the FES-LCE+PRT group (mean difference=4.5±7.9 Nm, 45% change, p<0.05) was consistently higher than that in the FES-LCE group (mean difference=2.4±10.3 Nm, 4% change; p<0.018). The improvement in the right quadriceps muscle's peak torque of the FES-LCE+PRT group (mean difference=19±7.6 Nm, 31% change, p<0.05) was more significant compared to the FES-LCE group. The left muscle volume showed a remarkable increase after 12 weeks in the FES-LCE+PRT group (mean difference=0.3±9.3 L, 7% change, p<0.05). Conclusion: The combination of PRT and FES-LCE was better in improving lower limb muscle strength and volume in chronic incomplete individuals with spinal cord injury.

Effect of resistance training on local muscle endurance in middle-aged and older adults: A systematic review with meta-analysis and meta-regression.

BACKGROUND: Local muscle endurance (LME) is a significant indicator of muscle health and function in middle-aged and older adults. However, resistance training (RT) practices which optimise performance in this population are currently unclear. This study examined: 1) the effect of RT on LME; and 2) the impact of acute resistance exercise program variables on LME in middle-aged and older adults. METHODS: Five electronic databases were searched using terms related to RT, LME, and older adults. Random effects (Hedges' g) meta-analyses were undertaken to estimate the effect of RT on upper and lower body LME assessed via maximal repetitions during an isotonic test. The impact of resistance exercise program variables on LME effects was explored using meta-regression analyses. RESULTS: Fifteen studies met the inclusion criteria for this review. Upon sensitivity analysis, one study was removed. Large effects favoured RT for LME of the upper body (g = 1.10, p < 0.001) and lower body (g = 1.18, p < 0.001). Large effects on LME from RT were found irrespective of training intensity or other resistance exercise program variables. Moderate heterogeneity and publication bias were found in most analyses. DISCUSSION: RT is an effective means for improving LME in middle-aged and older adults. Optimal training characteristics have not been defined by this review, as improvement in LME was unrelated to RT volume or loading intensity. Caution is warranted when interpreting the findings due to heterogeneity and bias present in existing literature. Additional studies are needed with direct comparisons of various training techniques.

Leisure-Time Physical Activity in People With Spinal Cord Injury-Predictors of Exercise Guideline Adherence.

Objectives: This study described leisure-time physical activity (LTPA) for people in Australia with spinal cord injury (SCI) and whether certain sociodemographic and psychosocial variables might be associated with LTPA uptake and guidelines adherence. Methods: The Physical Activity Scale for Individuals with a Physical Disability was used to measure the intensity and volume of LTPA of 1,579 individuals with SCI. Summary statistics were calculated for LTPA guidelines adherence. Analyses included regression modelling. Results: Of the 1,579 participants, 58% performed LTPA and 13% adhered to recommended guidelines for weekly LTPA. There was an association with being an "exerciser" based on the time since injury (OR = 1.02 [95% 1.01-1.03]), a traumatic injury (OR = 1.53 [95% CI 1.13-2.08]) and a higher self-rating of health (OR = 1.10 [95% CI 0.95-1.27]). Where LTPA guidelines were met, adherence was most related to a traumatic injury (OR = 1.75 [95% CI 1.02-3.02]) and being unemployed (OR = 1.53 [95% CI 1.03-2.25]). Conclusion: Of those who performed LTPA with SCI, one in four met population-specific LTPA guidelines. Sociodemographic variables were moderately associated with being an "exerciser" or LTPA "guideline-adherent."

Mechanomyography and tissue oxygen saturation during electrically-evoked wrist extensor fatigue in people with tetraplegia.

BACKGROUND: Repetitive electrically-evoked muscle contractions lead to the early onset of muscle fatigue. This study assessed the relationship between muscle mechanomyography (%RMS-MMG) and tissue oxygen saturation (%TSI) in extensor carpi radialis (ECR) during electrically-evoked fatiguing exercise in individuals with tetraplegia. METHODS: Skin-surface mechanomyography (MMG) and near-infrared spectroscopy (NIRS) sensors were placed on the ECR of seven individuals with tetraplegia. All participants performed repetitive electrically-evoked wrist extension to fatigue while their muscle MMG and NIRS responses were monitored against their power output (PO). FINDINGS: One out of seven participants showed no changes in %TSI throughout the repeated wrist FES-evoked contraction. The other six participants' %TSI was positively correlated with %PO before fatigue onset. At 50%POpeak , %TSI was negatively correlated (0.489) significantly with declining %PO as the ability of the muscle to take up oxygen became limited. The %RMS-MMG behaved analogously during pre and post-fatigue against declining %PO, whereby both displayed positive correlations of 0.443 and 0.214, respectively, (%RMS-MMG decreased) throughout the exercise session. Regression analysis revealed that %TSI was proportional to pre-fatigue and inversely proportional to %RMS-MMG during post-fatigue. CONCLUSION: The significant changes in muscle mechanomyography and tissue oxygenation correlations after 50%POpeak implied that the muscle contraction mechanical-and-physiological behavior association had been altered following FES-evoked fatigue.

Party keepers: a significant community-based intervention for harm reduction.

BACKGROUND: Gay men use recreational drugs more often than heterosexuals-especially at social events. While partying at a venue, partygoers are at risk of drug overdosing, without access to an emergency help. This study evaluates a unique and novel intervention aimed at training men who have sex with men (MSM) and transgender individuals who frequent parties, to provide immediate assistance on-site to partygoers who have overdosed. METHODS: The Party Keepers (PK) course is a unique 4-h training course that provides the participants with tools to identify, prevent, and treat common medical syndromes that are associated with excessive substance use. Participants were asked to complete a questionnaire on their sociodemographic attributes; their sexual risk behaviour; pre-exposure prophylaxis (PrEP) use and drug-use behaviour before and after the course; and the emergency situations they encountered in party venues after the course. RESULTS: Of the 85 participants who completed the training and left valid contact information, 52 (62%) completed the questionnaires. Their average age was 37.0 years, most lived in Tel-Aviv, and were single. Participants reported that, after the course, they reduced their own use of recreational drugs (cocaine, amyl nitrates, alcohol), reduced their sexual risk behaviours, and significantly increased their use of PrEP. Of all the PKs, 63% (N = 32) indicated that they now provided first-aid and other assistance to partygoers at public venues, which enhanced their sense of community responsibility. In the multivariate analysis, a high level of confidence as a PK, and the knowledge gained in the course, predicted the incidence of subsequent assistance to partygoers in emergency situations. CONCLUSIONS: The PK initiative-a harm-reduction intervention led by peers, aimed at fighting drug overdosing at gay venues-was useful in reducing drug use and sexual risk behaviours among the course participants. Most course participants also responded to drug-related emergency situations at gay parties, as a result. This evaluation of community health intervention within a sexual minority community can help health policy makers design more community based interventions and allocate resources to include community participants in harm-reduction policies.

Benefits and interval training in individuals with spinal cord injury: A thematic review.

BACKGROUND: Arm crank ergometry (ACE), functional electrical stimulation leg cycling exercise (FES-LCE), and the combination of the two (FES hybrid exercise) have all been used as activities to help improve the fitness-related health of individuals with spinal cord injury (SCI). More recently, high-intensity interval training (HIIT) has become popular in the non-disabled community due to its ability to produce greater aerobic fitness benefits or equivalent benefits with reduced time commitment. OBJECTIVE: This thematic review of the literature sought to determine the potential benefits and practicality of using ACE, FES-LCE, and FES hybrid exercise in an interval training format for individuals with SCI. METHODS: Systematic literature searches were conducted in May 2020 and March 2021 focusing on interval training in individuals with SCI. Pre-defined nested search terms were used to narrow the available literature from 4273 citations to 1362 articles. The titles and abstracts were then reviewed to determine the appropriateness of the articles ending with fifteen articles. RESULTS: The literature was limited to fifteen articles with low participant numbers (n = 1-20). However, in each article, HIIT protocols either demonstrated a greater improvement in cardiovascular, metabolic, or practicality scores compared to moderate intensity continuous training (MICT) protocols, or improvement during relatively brief time commitments. CONCLUSION: The available literature lacked sufficient numbers of randomized control trials. However, the available evidence is encouraging concerning the potential benefits and practicality of using HIIT (ACE, FES-LCE, or FES hybrid exercise) to improve aerobic and anaerobic capacity and decrease cardiometabolic risk after SCI.

Physical activity recall assessment for people with spinal cord injury: Thai translation and cross-cultural adaptation.

PURPOSE: This research sought to translate and culturally adapt the content of the original Physical Activity Recall Assessment for People with Spinal Cord Injury (PARA-SCI) into the Thai language and to assess its inter- and intra-rater reliability. METHODS: This study was divided into two parts; (i) translation and cross-cultural adaptation, using a six-step guideline-based translation-validation process and (ii) reliability assessment of the translated survey tool using intraclass correlation coefficients (ICCs), Bland-Altman plots and one-way ANOVA analyses. RESULTS: The Thai-PARA-SCI was successfully developed. The results revealed an excellent inter-rater reliability (ICC = 0.99, 95% CI range from 0.959-0.999) and the Bland-Altman plots showed little difference in times spent engaged physical activity. Intra-rater reliability results were affected inadvertently by testing across an unusual period, demonstrating poor to moderate scores (ICC ranged from 0.05-0.69, 95% CI ranged from -0.067-0.830) with the Bland-Altman plots showing very different ranges of time spent on physical activity. CONCLUSION: This study achieved its aims of culturally and systematically translating the English PARA-SCI interview script into the Thai version with excellent scores for inter-rater reliability and was proven to be understandable by prospective users (Thai-PT) and participants (Thai-SCI).Implications for RehabilitationA robust cross-cultural translation and adaptation of the Physical Activity Recall Assessment for people with Spinal Cord Injury (PARA-SCI) into the Thai context has been undertaken, providing an effective exemplar for converting patient reported health outcome measures between languages of different root origins.When using the PARA-SCI as a pre- and post-intervention outcomes survey, clinicians should ensure that the timing of interview administration does not coincide with any unintended alterations in work-life balance, to ensure that the data are representative of the habitual physical activity levels performed by participants in their daily lives.Due to the possibility that physical activity levels could vary day-by-day or week-to-week, using the same day measurement findings may be a more reliable way to deploy the PARA-SCI than repeated assessments week(s) apart.

Assessing physical activity and health-related quality of life in individuals with spinal cord injury: a national survey in Thailand.

PURPOSE: This study sought to; (i) investigate the proportion of Thai individuals with spinal cord injury (Thai-SCI) who met SCI-specific physical activity (PA) guidelines, (ii) describe PA and health-related quality of life (HRQOL) of Thai-SCI across different sociodemographic strata, and, (iii) measure the variance in HRQOL associated with the intensity and volume of leisure-time physical activities (LTPA). METHODS: Two surveys, measuring PA and HRQOL, were used in this study. Descriptive analysis, parametric and non-parametric tests for comparing two or more groups were used to analyse the data. The relationship between PA levels and HRQOL scores was investigated using Spearman's correlation coefficients. All statistical significance level in this study were set to alpha < 0.05. RESULTS: From the 200 participants, 14.5% met aerobic, 20.5% met strength training and 13.5% met both aerobic and strength training SCI-specific PA guidelines. Sedentary Thai-SCI accounted for 49% of the study sample. Thai-SCI spent 132.0 ± 254.3 (mean ± SD) minutes per week on moderate-to-heavy intensity LTPA. Average Physical and Mental Component Summary (PCS and MCS scores) of Thai-SCI were 42.3 ± 7.6 and 49.3 ± 8.4 (mean ± SD), respectively. Increases in average LTPA of moderate-to-heavy intensities were weakly correlated with increases in PCS scores and its sub-domains (r = 0.1-0.3, n = 200, all p < 0.05). CONCLUSION: The average time spent on moderate-to-heavy intensity ADLs and LTPA were below SCI-specific PA guidelines and the WHO global recommendations for PA. The proportion of Thai-SCI who were sedentary was high, suggesting immediate action and implementation of strategies to promote PA for Thai-SCI.IMPLICATIONS FOR REHABILITATIONThe proportion of Thai people with spinal cord injury with a sedentary lifestyle was high.Healthcare providers in Thailand must engage to a greater degree in health-related physical activity promotion to effectively deliver physical activity and exercise knowledge to their clients with spinal cord injury.Likely, structured programs of physical activity and exercise deployed by healthcare professionals with the appropriate knowledge and skills might reverse the current trend to sedentary lifestyle in this population.Interventions to improve participation in physical activity and health-related quality of life should be tailored to the individual needs of Thai individuals with a spinal cord injury and might be better delivered seperately.

Physical activity interventions using behaviour change theories for women with breast cancer: a systematic review and meta-analysis.

PURPOSE: Physical activity is a well-established strategy to alleviate breast cancer-related adverse outcomes. To optimise health benefits, behaviour change theories provide frameworks to support women in improving their physical activity. This review aimed to evaluate (i) the effects of behaviour change theory-based physical activity interventions for women with breast cancer and (ii) the application of these theories. METHODS: Seven online databases were searched. Trials were included if randomised and controlled, involved physical activity interventions ≥ 12 weeks duration, used a behaviour change theory, and participants were < 3 years post-cancer treatment. Risk of bias and theory use were assessed. Data were synthesised narratively and meta-analysed. RESULTS: Forty articles describing 19 trials were included. Overall risk of bias was moderately high. Post-intervention pooled effect estimates were medium for self-reported (SMD = 0.57) and objectively measured physical activity (SMD = 0.52). Most trials cited the social cognitive theory (n = 10) and transtheoretical model (n = 9). Trials rarely applied theories in their entirety, expounded on behavioural mechanisms, or tailored interventions according to behavioural constructs. The most commonly used types of behavioural techniques were goals and planning (n = 18), shaping of knowledge (n = 18), feedback and monitoring (n = 17), and comparisons of outcomes (n = 17). CONCLUSIONS: The included trials were effective for increasing physical activity in women with breast cancer. Theories were applied using a wide range of approaches and levels of rigour, although shared the use of common behavioural techniques. IMPLICATIONS FOR CANCER SURVIVORS: Future research may benefit breast cancer survivors by more comprehensively applying behaviour change theories, emphasising individual patient needs and goals.

The "Super-Fontan" Phenotype: Characterizing Factors Associated With High Physical Performance.

Background: People with a Fontan circulation usually have moderately impaired exercise performance, although a subset have high physical performance ("Super-Fontan"), which may represent a low-risk phenotype. Methods: People with a "Super-Fontan" phenotype were defined as achieving normal exercise performance [≥80% predicted peak oxygen uptake (VO2) and work rate] during cardiopulmonary exercise testing (CPET) and were identified from the Australian and New Zealand Fontan Registry. A Fontan control group that included people with impaired exercise performance (<80% predicted VO2 or work rate) was also identified based on a 1:3 allocation ratio. A subset of participants were prospectively recruited and completed a series of physical activity, exercise self-efficacy, and health-related quality of life questionnaires. Results: Sixty CPETs ("Super-Fontan", n = 15; control, n = 45) were included. A subset ("Super-Fontan", n = 10; control, n = 13) completed a series of questionnaires. Average age was 29 ± 8 years; 48% were males. Exercise capacity reflected by percent predicted VO2 was 67 ± 17% in the entire cohort. Compared to the "Super-Fontan" phenotype, age at Fontan completion was higher in controls (4.0 ± 2.9 vs. 7.2 ± 5.3 years, p = 0.002). Only one (7%) person in the "Super-Fontan" group had a dominant right ventricle compared to 15 (33%) controls (p = 0.043). None of those in the "Super-Fontan" group were obese, while almost a quarter (22%) of controls were obese based on body mass index (p = 0.046). Lung function abnormalities were less prevalent in the "Super-Fontan" group (20 vs. 70%, p = 0.006). Exercise self-efficacy was greater in the "Super-Fontan" group (34.2 ± 3.6 vs. 27.9 ± 7.2, p = 0.02). Self-reported sports participation and physical activity levels during childhood and early adulthood were higher in the "Super-Fontan" group (p < 0.05). The total average time spent participating in structured sports and physical activity was 4.3 ± 2.6 h/wk in the "Super-Fontan" group compared to 2.0 ± 3.0 h/wk in controls, p = 0.003. There were no differences in self-reported current total physical activity score or health-related quality of life between groups (p ≥ 0.05). Conclusions: The "Super-Fontan" phenotype is associated with a healthy weight, lower age at Fontan completion, better exercise self-efficacy, and higher overall levels of sport and physical activity participation during physical development.