The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial.

PURPOSE: We aim to evaluate the effects of myofascial induction therapy (MIT) on the sequelae suffered by the survivors of HNC (sHNC). METHODS: We enrolled 46 sHNC in a randomized controlled trial (RCT), of whom 20 received a MIT protocol and 23 were placed on a waitlist while receiving the recommended treatment for 6 weeks. The MIT protocol included a total of 18 sessions, 3 days a week on alternate days for 6 weeks. Maximal mouth opening, the presence of temporomandibular dysfunction, cervical endurance, active range of motion (AROM), shoulder AROM, handgrip strength, and perceived physical fitness were assessed. RESULTS: Maximal mouth opening, temporomandibular dysfunction, cervical endurance, and AROM, affected shoulder abduction and unaffected shoulder flexion and external rotation significantly improved (p < .05) after an MIT protocol, but only cervical AROM and affected shoulder abduction changes were clinically meaningful. No statistically significant changes were observed in the other shoulder AROM, handgrip strength, or physical fitness perception (p > .05). CONCLUSION: A 6-week MIT protocol improves mouth opening, TMD, cervical function (endurance and AROM), affected shoulder abduction and unaffected shoulder flexion, and external rotation AROM in the sHNC. However, no changes were observed in most of the shoulder AROM, muscular strength, or perceived physical fitness. Future studies should perform longer follow-up designs, increase the sample size, and include multimodal treatments to address these sequelae in the sHNC.

Neurotoxicity prevention with a multimodal program (ATENTO) prior to cancer treatment versus throughout cancer treatment in women newly diagnosed for breast cancer: Protocol for a randomized clinical trial.

A current challenge in breast cancer (BC) patients is how to reduce the side effects of cancer and cancer treatments and prevent a decrease in quality of life (QoL). Neurotoxic side effects, especially from chemotherapy, are present in up to 75% of women with BC, which implies a large impact on QoL. There is a special interest in the preventive possibilities of therapeutic exercise (TE) for these neurological sequelae, and the benefits of TE could be improved when it is combined with vagal activation techniques (VATs). This superiority randomized controlled trial aims to examine the feasibility and efficacy of an 8-week multimodal intervention (ATENTO) based on moderate-vigorous intensity and individualized TE (aerobic and strength exercises) and VAT (myofascial and breathing exercises), on neurotoxicity prevention in women with BC before starting adjuvant chemotherapy (ATENTO-B) versus throughout adjuvant chemotherapy (ATENTO-T). A sample of 56 women newly diagnosed with BC, as calculated with a power of 85%, will be randomly allocated into these two groups. This study could provide an impetus for the introduction of early multimodal intervention methods to prevent neurotoxicity and consequently avoid the QoL deterioration that BC patients presently suffer throughout their treatments.

Association Between the Use of a Mobile Health Strategy App and Biological Changes in Breast Cancer Survivors: Prospective Pre-Post Study.

BACKGROUND: There is a bidirectional relationship between chronic low-grade inflammation and cancer. Inflammatory markers, such as interleukin-6 (IL-6), have been associated with both the malignant transformation of epithelial cells and tumor progression, thus linking low-grade inflammation with a higher risk of cancer and recurrence in the survival phase. Therefore, they are considered valuable prognostic biomarkers. Knowing and finding appropriate primary prevention strategies to modify these parameters is a major challenge in reducing the risk of cancer recurrence and increasing survival. Different therapeutic strategies have shown efficacy in the modification of these and other biological parameters, but with contradictory results. There are apparently no strategies in which telemedicine, and specifically mobile health (mHealth), are used as a means to potentially cause biological changes. OBJECTIVE: The objectives of this study were to: (1) check whether it is feasible to find changes in inflammation biomarkers through an mHealth strategy app as a delivery mechanism of an intervention to monitor energy balance; and (2) discover potential predictors of change of these markers in breast cancer survivors (BCSs). METHODS: A prospective quasi-experimental pre-post study was conducted through an mHealth energy balance monitoring app with 73 BCSs, defined as stage I-IIIA of breast cancer and at least six months from the completion of the adjuvant therapy. Measurements included were biological salivary markers (IL-6 and C-reactive protein [CRP]), self-completed questionnaires (the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, the user version of the Mobile Application Rating Scale [uMARS] and an ad hoc clinical and sociodemographic questionnaire) and physical objective measures (accelerometry, weight and height). In addition, using the logging data of the mHealth app, the rate of use (in days) was recorded during the entire experimental phase of the study. Using Stata software, a paired two-tailed t test, Pearson and Spearman correlations, and a stepwise multiple regression analysis were used to interpret the data. RESULTS: Analyzing changes in inflammatory biomarker concentrations after using the mHealth app, differences between preassessment CRP (4899.04 pg/ml; SD 1085.25) and IL-6 (87.15 pg/ml; SD 33.59) and postassessment CRP (4221.24 pg/ml; SD 911.55) and IL-6 (60.53 pg/ml; SD 36.31) showed a significant decrease in both markers, with a mean difference of -635.25 pg/ml (95% CI -935.65 to -334.85; P<.001) in CRP and -26.61 pg/ml (95% CI -42.51 to -10.71; P=.002) in IL-6. Stepwise regression analyses revealed that changes in global quality of life, as well as uMARS score and hormonal therapy, were possible predictors of change in CRP concentration after using the mHealth app. In the same way, the type of tumor removal surgery conducted, as well as changes in weight and pain score, were possible predictors of change in IL-6 concentration after using the app. CONCLUSIONS: In conclusion, through the results of this study, we hypothesize that there is a possible association between an mHealth energy balance monitoring strategy and biological changes in BCSs. These changes could be explained by different biopsychosocial parameters, such as the use of the application itself, quality of life, pain, type of tumor removal surgery, hormonal treatment or obesity.

A home-based tele-rehabilitation protocol for patients with hip fracture called @ctivehip.

Home-based tele-rehabilitation programs are under development and may be a future option for some patients. The objectives of this non-randomized clinical trial are to design a home-based multidisciplinary tele-rehabilitation protocol for patients with hip fracture, and to compare this protocol versus the home-based usual outpatient rehabilitation protocol. Seventy patients treated for an acute hip fracture, aged 65 years or older, with a high pre-fracture functional level (Functional Independence Measure score >90), without severe cognitive impairment, absence of terminal disease, discharged to their own home or a relativés home postoperatively, allowed weight-bearing, and with signed informed consent, will be allocated into a tele-rehabilitation group (n = 35) or a control group (n = 35). The inclusion criterion for the intervention group will be to have a caregiver with the ability to access the Internet who is willing to perform exercises and activities with the patient at home. The intervention includes a program of physical exercise and occupational therapy (five weekly sessions during 12 weeks), and recommendations for patients and their caregivers, all delivered through a website. The patient's functional level (Functional Independence Measure), quality of life (Euro-Qol), physical performance (Timed Up and Go), caregiver burden (Zarit Interview), and other descriptive data will be assessed at hospital discharge, 4 weeks, and 12 weeks. This project will add to the knowledge concerning the feasibility of tele-rehabilitation as an option to promote recovery of the pre-fracture functional level for some patients with a hip fracture. ClinicalTrials.gov Identifier: NCT02968589NCT.

Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial.

PURPOSE: This trial determines the effect of an Internet-based tailored exercise program compared to usual care control for improving functional capacity and cognition among breast cancer survivors. METHODS: A two-arm, assessor-blinded, parallel, randomized controlled efficacy trial was conducted. Participants were recruited from the Oncology and Breast unit at the Virgen de las Nieves Hospital (Granada, Spain) between March 2012 to November 2013 and randomized to either the experimental group (an 8-week Internet-based tailored exercise program) or control group (usual care). The outcome measures were the 6-min walk test, Auditory Consonant Trigrams, and Trail Making Test. All were assessed at baseline, post-intervention, and 6-month follow-up. RESULTS: After intervention, the telerehabilitation group had significantly improved distances (d = 0.92, P < 0.001) as well as percentage of predicted of the 6-min walk test (d = 0.93, P < 0.001) compared with the control group. Significant improvement was also observed favoring the telerehabilitation group for the number of consonants recalled in total compared with the control group (d = 0.47, P = 0.04). These findings were maintained after 6-month follow-up (d = 0.80, P = 0.001; d = 0.76, P = 0.002; and d = 0.57, P = 0.02, respectively). Analysis was based on intention-to-treat principle. CONCLUSIONS: These findings support the effectiveness of a telehealth system based on an 8-week physical exercise to achieve improvements and maintain them after 6-month follow-up in terms of functional and cognitive performance in breast cancer survivors. This broad-reach modality could help the growing number of cancer survivors to face their disabling side effects.

Analysis of Pressure Pain Hypersensitivity, Ultrasound Image, and Quality of Life in Patients with Chronic Plantar Pain: A Preliminary Study.

OBJECTIVES: To evaluate widespread pressure pain in patients with chronic plantar heel pain compared with that in healthy controls and to investigate the differences in ultrasound imaging and quality of life between these two groups. METHODS: A total of 22 patients (11 female) with chronic plantar heel pain and the same number of healthy patients, matched according to age and gender, were included in this pilot study. Pressure pain thresholds (PPTs) were bilaterally assessed over the calcaneus bone, the plantar fascia, the first and fifth metatarsals, the soleus muscle, the second metacarpal, and the zygapophyseal joint of C5-C6. Plantar fascia thickness was measured via ultrasound imaging. In addition, quality of life and physical function were assessed using the Short-Form 36 (SF-36) questionnaire and the Foot and Ankle Ability Measure (FAAM) questionnaire, respectively. RESULTS: Analysis of covariance (ANCOVA) results showed significant differences in the PPTs at all points between the groups (P < 0.001), but not between sides. The PPTs were significantly lower in the patients than in the controls at all sites (P < 0.05). The results showed significant increases in fascia thickness at the calcaneus insertion (group: F = 74.172, P ≤ 0.001; side: F = 8.920, P ≤ 0.001) and the middle fascia point (group: F = 133.685, P = <0.001; side: F = 11.414, P = <0.001) on ultrasound in the patient group compared with the matched control group. The analysis also revealed that the patient group had a significantly lower score on every subscale of the SF-36 and FAAM questionnaires (all P < 0.001), except for the mental component, compared with the matched control group. DISCUSSION: Patients suffering from chronic plantar heel pain showed widespread and bilateral hypersensitivity, increased thickness of the plantar fascia in the affected foot, and deterioration in quality of life and physical functioning compared with matched controls.

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial.

BACKGROUND: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life in breast cancer survivors. METHODS: This therapeutic superiority study will use a two-arm, assessor blinded parallel RCT design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25 kg/m2; they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a face-to-face rehabilitation (8-weeks); m-health group will use the BENECA app for 2-months and will received usual care information. Study endpoints will be assessed after 8 weeks and 6 months. The primary outcome will be Quality of Life measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trail Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); physical fitness (Short version of the Minnesota Leisure Time Physical Activity Questionnaire, Self-Efficacy Scale for Physical Activity); accelerometry and lymphedema. DISCUSSION: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02817724 (date of registration: 22/06/2016).

The Six-Minute Walk Test as a Measure of Health in Breast Cancer Patients.

This study examined the relationship between the 6-min walk test (6MWT) and fitness, psychological and physiologic states, quality of life, cancer-related symptoms, and body composition of 87 women with breast cancer. The assessment included the 6MWT and evaluations of Cancer Quality of Life (EORTC C-30 and EORTC BR-23), cognitive performance (Trail Making Test), the Hospital Anxiety and Depression Scale, body composition, health-related fitness (abdominal test, multiple sit-to-stand test, trunk dynamometry), and pain (Brief Pain Inventory). We observed the following correlations: moderate between 6MWT and pain interference; modest for cognitive and social functioning and the multiple sit-to-stand test; fair for several items on the Cancer Quality of Life, for anxiety, lean body mass, trunk dynamometry and pain intensity; and weak for role functioning, loss of appetite, cognitive performance and depression. Thus, the 6MWT could be used as a measure of the major components of global health in women with breast cancer.

Shoulder pain and disability index: cross cultural validation and evaluation of psychometric properties of the Spanish version.

BACKGROUND: The Shoulder Pain Disability Index (SPADI) is a recently published but widely used outcome measure. METHODS: This study included 136 patients with shoulder disorders. SPADI was first translated and back-translated and then subjected to psychometric validation. Participants completed the Spanish versions of the SPADI, general health (SF-12), the Simple Shoulder Test (SST), Disability of Arm, Shoulder, and Hand (DASH) questionnaires and a pain intensity visual analog scale (VAS). RESULTS: The factors explained 62.8 % of the variance, with an internal consistency of α = 0.916 and 0.860, respectively. The confirmatory factor analysis showed a Comparative Fit Index of 0.82 and a Normed Fit Index of 0.80. The Root Mean Square Error of Aproximation was 0.12. The x (2) test for the 2-factor model was significant (x (2) = 185.41, df = 62, p < 0.01). The test-retest reliability was high, with an item ranging of the interclass correlation coefficient (ICC) from 0.89 to 0.93. The ICC for the total score was 0.91 (95 % CI 0.88 to 0.94). Measurement error by minimal detectable change (MDC)95 was 12.2 %. In the construct validity analysis, strong positive correlations were observed between Spanish Version of the SPADI and DASH (pain: r = 0.80; p < 0.01; disability: r = 0.76; p < 0.01). Moderate positive correlations were observed between Spanish Version of the SPADI and VAS (pain: r = 0.67; p < 0.01; disability: r = 0.65; p < 0.01). Moderate negative correlations were obtained between Spanish Version of the SPADI and SST-Sp (pain: r = -0.71; p < 0.01; disability: r = -0.75; p < 0.01). However, pain total Spanish Version of the SPADI was only weakly correlated with physical and mental components of SF-12 (both r = 0.40; p < 0.01). CONCLUSIONS: This Spanish version of SPADI demonstrated satisfactory psychometric properties in a patient sample in the hospital setting.

Predictors of long-term mortality in older people with hip fracture.

OBJECTIVES: To determine 1-year mortality and predisposing factors in older people who had surgery after a hip fracture. DESIGN: Prospective cohort study. SETTING: Public acute hospital, trauma service. PARTICIPANTS: Patients (N=281) aged ≥65 years who were admitted to the hospital with a hip fracture from January 2009 to January 2010, and followed up for 1 year thereafter. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Cumulative survival probability up to 1 year from surgery was calculated by means of Kaplan-Meier charts, and Cox regression models were performed to analyze the factors associated with mortality. Data were collected from medical charts and by interviews. Health status was evaluated using the American Society of Anesthesiologists rating, prefracture functional level with the FIM, and cognitive status with the Pfeiffer score. RESULTS: The 1-year mortality for the 281 patients who were followed up was 21% (95% confidence interval [CI], 16.1%-25.9%). A non-weight-bearing status was associated with increased mortality in unadjusted analyses (hazard ratio [HR]=1.99; 95% CI, 1.16-3.43), but 5 other factors were identified when entered into the multiple Cox regression model: age (HR=1.05; 95% CI, 1-1.09), male sex (HR=2.92; 95% CI, 1.58-5.39), low health status (HR=2.8; 95% CI, 1.29-6.09), low prefracture function (HR=.98; 95% CI, .97-.99), and change of residence (HR=3.21; 95% CI, 1.43-7.17). CONCLUSIONS: The overall 1-year mortality rate was 21%. Change of residence is the only potentially modifiable risk factor, independent of the following other traditional risk factors that were found: age, sex, health status, and prefracture functional level. Furthermore, 2 to 4 weeks of non-weight-bearing status, which is considered modifiable, is also associated with increased mortality rates in unadjusted analyses.

Effectiveness of an occupational therapy intervention in reducing emotional distress in informal caregivers of hip fracture patients: a randomized controlled trial.

OBJECTIVE: To examine the effectiveness of an occupational therapy intervention program in reducing emotional distress in informal caregivers of hip fracture patients. DESIGN: Single-blind randomized controlled trial. SETTING: A public Trauma and Rehabilitation Hospital in Granada, Spain. PARTICIPANTS: A total of 186 caregivers and their care recipients with hip fracture (93 in each group) were allocated to an intervention group or a control group using a block system. INTERVENTION: An occupational therapy intervention during patient hospitalization focused on patient handling by caregivers and ergonomic treatment for both. MAIN MEASURES: The Goldberg General Health Questionnaire was used to measure emotional distress and psychological well-being. The Goldberg Anxiety and Depression Scale was used to measure caregiver affective illness. RESULTS: Among informal caregivers, emotional distress decreased to a greater extent in the intervention group than in the control group from the first assessment to the six-month follow-up (intervention group: 4.16 (SD 4.57) to 2.81 (SD 2.93); control group: 4.61 (SD 4.57) to 4.24 (SD 4.30)), showing significant differences at the first, third and sixth month. As regards anxiety levels, significant differences were only found at the third month (1.54 (SD 2.09) vs. 2.35 (SD 2.53) in the intervention and control groups, respectively (p < 0.05)), although the intervention group always showed lower levels from the first month. Although depression levels decreased in both groups, the decrease was also greater in the intervention group. CONCLUSION: Occupational therapy training for caregivers of hip fracture patients helps to significantly reduce emotional distress, anxiety and depression in caregivers.

Effect of occupational therapy on functional and emotional outcomes after hip fracture treatment: a randomized controlled trial.

OBJECTIVE: To explore whether an occupational therapy intervention combined with physiotherapy rehabilitation improved hip fracture patient outcomes regarding emotional distress, fatigue, independence and function. DESIGN: Randomized controlled trial. SETTING: Inpatient trauma ward in a rehabilitation and trauma hospital. PARTICIPANTS: One hundred and twenty-two patients admitted into hospital for hip fracture. INTERVENTION: Patients were randomly assigned to a standard care group (SC, n = 61) or a combined treatment group (CT, n = 61). The SC group received conventional hospital care for hip fracture patients and the CT group underwent occupational therapy as well. MAIN MEASURES: Patients' emotional distress (GHQ-28), perceived fatigue (the first item of the BASDAI using a 0-100 visual analogue scale scale), level of independence (Modified Barthel Index) and function (Harris Hip Score) were measured at baseline and one, three and six months after the intervention. RESULTS: Patients in the CT group experienced a considerable decrease of emotional distress at three and six months (p = 0.005 and p < 0.001, respectively). A between-group analysis showed significant differences in emotional distress at one, three and six months (p < 0.001). Although fatigue levels decreased in the SC group, the most significant decline was reported by the CT group at six months (p < 0.001, mean difference = 14 points). Regarding independence level, significant differences were found within groups at each stage, but also between groups at one month in favor of the CT group. Function improved in both groups compared with baseline (p < 0.001), but no significant differences were found in functionality between groups. CONCLUSION: Although both groups reported significant improvements, patients in the CT group had better scores in emotional distress and dependence throughout follow-up and better scores in all measures at six months.

Effect of mHealth plus occupational therapy on cognitive function, mood and physical function in people after cancer: Secondary analysis of a randomized controlled trial.

BACKGROUND: Medical and surgical treatments for breast cancer have various adverse effects. Both mobile health and supervised intervention strategies have been implemented to overcome these effects, but some gaps remain to be addressed. Scientific evidence for the effectiveness of occupational therapy in cancer is limited. OBJECTIVE: To compare the clinical effectiveness of the BENECA mHealth app used alone or combined with an integral supervised rehabilitation strategy that focused on cognitive performance, mood state, functional capacity, and cancer-related pain and fatigue in overweight women after breast cancer. METHODS: In this secondary analysis of an assessor-blinded randomized controlled clinical trial, 80 overweight women after breast cancer (stage I-IIIA) were randomly allocated to an integral approach group (IA; n=40) or a control group (CG; n=40). All participants participated in an 8-week intervention. Assessments were performed at baseline, 8 weeks, and 6 months and included cognitive performance (Trial Making Test and Wechsler Adult Intelligence Scale), psychological state (Hospital Anxiety and Depression Scale), pain (Brief Pain Inventory), fatigue (Piper Fatigue Scale), and physical function (6 min walk test). An intention-to-treat analysis was conducted with analysis of covariance. RESULTS: Selective attention (TMT) was significantly higher in the IA group, with a moderate to large effect size for TMT A (T2: d=1.1; T 3: d=1.2), working memory and processing speed (WAIS), anxiety and general HADS score (d=1.6), and functional capacity at 8 weeks and 6 months (d=1.5). Fatigue perception (mean difference, -0.6; 95% CI -1.4 to 0.04; p=0.009) and pain (intensity level p<0.001; interference level p=0.002) were also significantly more improved in the IA group. CONCLUSIONS: An integral strategy involving the BENECA mHealth app with a supervised, multimodal intervention improved cognitive, psychological, and functional performance in women after breast cancer more than mHealth alone. Occupational therapy has a role to play in breast cancer rehabilitation.

Is a telerehabilitation programme for older adults with hip fracture associated with burden of family caregivers who provide support?

Objective: @ctivehip is a home-based multidisciplinary telerehabilitation programme for older adults with hip fracture, conducted with the assistance of their family caregivers. This programme was useful in improving their functional recovery. Nevertheless, we were concerned about how the programme might have affected caregivers, whose assistance was essential for supporting older adults in using new technologies and ensuring their safety during the exercises and activities at home. The aim of the present study was to compare the burden, psychological factors and physical fitness of the family caregivers of older adults who opted the @ctivehip telerehabilitation programme versus those family caregivers of older adults who received the face-to-face rehabilitation provided by the Andalusian Public Healthcare System (in Spain). Methods: In this single-blinded, non-randomized clinical trial, participants were older adults with hip fracture and their family caregivers. The telerehabilitation group (n = 30) underwent a 12-week multidisciplinary telerehabilitation programme, and the comparative group (n = 32) received face-to-face rehabilitation. Caregivers outcomes measured were (i) the burden using the Zarit Burden Interview, (ii) the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS), and (iii) the Physical Fitness with the International Fitness Scale (IFIS). Results: There were not statistically significant differences on caregiver burden between family caregivers in the @ctivehip and the comparative group, although there was a trend towards lower values [[Mean (95%CI); 14.73 (9.09 to 20.37) vs 16.03 (10.63 to 21.43); p = 0.771] as well as for anxiety and depression [5.66 (3.21 to 8.78) vs 11.19 (8.52 to 13.86); p = 0.022]. Likewise achieved better, though not statistically significant, scores in physical fitness [19.37 (17.94 to 20.81) vs 17.15 (15.77 to 18.53); p = 0.055]. Conclusion: Caregiver burden is not associated with telerehabilitation. In addition, telerehabilitation is associated with lower anxiety and depression levels among family caregivers who opt for this programme. Physical fitness is not related with telerehabilitation.

Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol.

INTRODUCTION: Pain is one of the most persistent symptoms after cancer treatment. The central nervous system can erroneously stay in its alarm phase, altering the pain experience of patients who have cancer. Pain neuroscience education (PNE) with multimodal approaches may benefit these patients. OBJECTIVE: This protocol aims to determine the effectiveness of a PNE tool on pain, physical function and quality of life, as a supplement to a multimodal rehabilitation (MR) program in patients who had breast cancer (BC). METHODS: An 8-week double-blinded randomized controlled trial will be conducted, including 72 participants who had BC and who have persistent pain, randomized into three groups: PNE program + MR program, traditional biomedical information + MR program and control group. The PNE program will include educational content that participants will learn through a mobile app and the MR program will include a concurrent exercise program and manual therapy. The primary outcome will be the perceived pain assessed using the Visual Analogue Scale and secondary outcomes are others related to pain, physical function and quality of life. All outcomes will be evaluated at baseline, at the end of the intervention and 6 months after the end of intervention. DISCUSSION: The proposed study may help BC patients with persistent pain improve their pain experience, quality of life and provide for more adaptive pain-coping strategies. This protocol could propose an action guide to implement different integral approaches for the treatment of sequelae. This treatment option could be offered to this patient profile and it could be easily implemented in the healthcare systems due to its low costs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04877860. (February18, 2022).

Effects of the @ctivehip telerehabilitation program on the quality of life, psychological factors and fitness level of patients with hip fracture.

INTRODUCTION: Telerehabilitation has emerged in the last decade as a promising alternative to conduct the rehabilitation process at home. However, there are no studies testing the effects of telerehabilitation interventions for patients with hip fracture on quality of life nor psychological factors, whereas the evidence on fitness level is scarce. Thus, the aim of this study is to test the effects of the @ctivehip telerehabilitation program on the quality of life, psychological factors and fitness level of patients who had suffered a hip fracture. METHODS: The present study is a non-randomized clinical trial that includes patients older than 65 years old with a hip fracture and their family caregivers (ClinicalTrials.gov; Identifier: NCT02968589). Per-protocol (64 participants) and intention-to-treat (71 participants) analyses were performed, the first being the main analysis. The intervention group received a home-based multidisciplinary telerehabilitation intervention, called @ctivehip, that lasted 12 weeks. The control group received the traditional care and rehabilitation provided by the Andalusian Public Health Care System. The outcomes measured were the patients' quality of life through the EuroQol Quality of Life Questionnaire (EQ-5D), physiological factors (anxiety and depression) using the Hospital Anxiety and Depression Scale (HADS) and the fitness level, assessed with the International Fitness Scale. RESULTS: The quality of life of the telerehabilitation group increased, while the control group scored worsened at the 3-month follow-up (medium effect size: 0.66 SDs; p = 0.006). The telerehabilitation group demonstrated a greater decrease than the control group in the total HADS score (medium effect size: -0.50 SDs; p = 0.015). Lastly, the telerehabilitation group recovered a fitness level close to the pre-hip fracture in comparison with the control group (small effect size: 0.49 SDs; p = 0.022). DISCUSSION: The @ctivehip telerehabilitation program seems to be a promising treatment to improve the quality of life and psychological factors (i.e. anxiety and depression) of older adults after a hip fracture, as well as to recover their previous fitness level.

Factors Influencing Quality of Life in Survivors of Head and Neck Cancer: A Preliminary Study.

OBJECTIVES: Time after diagnosis, survivors of head and neck cancer may perceive a decrease in their quality of life due to suffering from different sequelae. This preliminary study aims to describe which factors influence survivors of head and neck cancer quality of life. DATA SOURCES: A cross-sectional study was performed. Demographic and clinical factors, quality of life (global health status), pain (pressure pain thresholds), physical fitness (overall fitness), functional capacity, and fatigue were evaluated. A multiple regression model was undertaken to check which outcomes could impact quality of life. A total of 53 survivors of head and neck cancer participated in this study. Upper trapezius pressure pain threshold, overall fitness, and global fatigue were significant predictors of global health status, and when combined, they explained 42.10% of the variance in the global health status score. CONCLUSION: Quality of life perceived by survivors of head and neck cancer is influenced by pain, physical fitness, and fatigue reported. This association of outcomes may act as a symptom cluster for survivors of head and neck cancer. IMPLICATIONS FOR NURSING PRACTICE: The knowledge of this symptom cluster may help developing symptom assessment and management strategies and improving quality of life for survivors of head and neck cancer.

A Telehealth-Based Cognitive-Adaptive Training (e-OTCAT) to Prevent Cancer and Chemotherapy-Related Cognitive Impairment in Women with Breast Cancer: Protocol for a Randomized Controlled Trial.

BACKGROUND: Many women with breast cancer experience a great number of side effects, such as cognitive impairment, during and after chemotherapy that reduces their quality of life. Currently, research focusing on the use of non-pharmacological, and specifically telehealth interventions to prevent or mitigate them has been insufficient. METHODS: This protocol describes a randomized controlled trial aimed at studying the preventive effects of a videoconferenced cognitive-adaptive training (e-OTCAT) program (ClinicalTrials.gov NCT04783402). A number of 98 eligible participants will be randomized to one of the following groups: (a) the experimental group receiving the e-OTCAT program during 12 consecutive weeks since the beginning of chemotherapy; and (b) the control group receiving and educational handbook and usual care. The primary outcome will be the cognitive function. Secondary measures will be psychological distress, fatigue, sleep disturbance, quality of life and occupational performance. The time-points for these measures will be placed at baseline, after 12 weeks and six months of post-randomization. CONCLUSION: This trial may support the inclusion of multidimensional interventions through a telehealth approach in a worldwide growing population suffering from breast cancer, emphasizing the prevention of cognitive impairment as one of the side effects of cancer and its treatments.

Prevention of Chemotherapy-Induced Peripheral Neuropathy With PRESIONA, a Therapeutic Exercise and Blood Flow Restriction Program: A Randomized Controlled Study Protocol.

OBJECTIVE: This trial will analyze the acute and cumulative effects of a tailored program called PRESIONA that combines therapeutic exercise and blood flow restriction to prevent chemotherapy-induced peripheral neuropathy (CIPN) in individuals with early breast cancer undergoing neoadjuvant chemotherapy. METHODS: PRESIONA will be a physical therapist-led multimodal exercise program that uses blood flow restriction during low-load aerobic and strength exercises. For the acute study, only 1 session will be performed 1 day before the first taxane cycle, in which 72 women will be assessed before intervention and 24 hours post intervention. For the cumulative study, PRESIONA will consist of 24 to 36 sessions for 12 weeks following an undulatory prescription. At least 80 women will be randomized to the experimental group or control group. Feasibility will be quantified based on the participant recruitment to acceptance ratio; dropout, retention, and adherence rates; participant satisfaction; tolerance; and program security. In the efficacy study, the main outcomes will be CIPN symptoms assessed with a participant-reported questionnaire (EORTC QLQ-CIPN20). In addition, to determine the impact on other participant-reported health and sensorimotor and physical outcomes, the proportion of completed scheduled chemotherapy sessions will be examined at baseline (t0), after anthracycline completion (t1), after intervention (t2), and at the 2-month (t3) and 1-year follow-ups (t4). CONCLUSION: The proposed innovative approach of this study could have a far-reaching impact on therapeutic options, and the physical therapist role could be essential in the oncology unit to improve quality of life in individuals with cancer and reduce side effects of cancer and its treatments. IMPACT: Physical therapists in the health care system could be essential to achieve the planned doses of chemotherapy to improve survival and decrease the side effects of individuals with breast cancer. The prevention of CIPN would have an impact on the quality of life in these individuals, and this protocol potentially could provide an action guide that could be implemented in any health care system.