The MIPAM trial: a 12-week intervention with motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity in community-dwelling older adults - a study protocol for a randomized controlled trial.

BACKGROUND: Physical Activity Monitors (PAMs) have been shown to effectively enhance level of physical activity (PA) in older adults. Motivational interviewing is a person-centred model where participants are guided using self-reflection and counselling, and addresses the behavioural and psychological aspects of why people initiate health behaviour change by prompting increases in motivation and self-efficacy. The addition of motivational interviewing to PA interventions may increase the effectiveness of PAMs for older adults. METHODS: This motivational interviewing and PA monitoring trial is designed as an investigator-blinded, two arm parallel group, randomized controlled superiority trial with primary endpoint after 12 weeks of intervention. The intervention group will receive a PAM-based intervention and motivational interviewing and the control group will only receive the PAM-based intervention. The primary outcome is PA, objectively measured as the average daily number of steps throughout the intervention period. Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations. The outcomes will be analysed with a linear regression model investigating between-group differences, adjusted for baseline scores. Following the intention to treat principle, multiple imputation will be performed to handle missing values. DISCUSSION: A moderate effect of daily PA measured using PAMs is expected in this superiority RCT investigating the effect of adding motivational interviewing to a PAM intervention. According to the World Health Organization, walking and cycling are key activities in regular PA and should be promoted. To increase the general public health and lower the burden of inactivity in older adults, cost-beneficial solutions should be investigated further. If this RCT shows that motivational interviewing can enhance the effect of PAM-based interventions, it might be included as an add-on intervention when appropriate. No matter what the results of this study will be, the conclusions will be relevant for clinicians as the dependence on technology is increasing, especially in relation to public health promotion. TRIAL REGISTRATION: NCT03906162 , April 1, 2019.

Mesenchymal Stromal/Stem Cell Therapy Improves Salivary Flow Rate in Radiation-Induced Salivary Gland Hypofunction in Preclinical in vivo Models: A Systematic Review and Meta-Analysis.

BACKGROUND: Mesenchymal stromal/stem cells (MSCs) have been suggested for salivary gland (SG) restoration following radio-induced salivary gland damage. This study aimed to determine the safety and effectiveness of MSC therapy on radio-induced SG damage and hypofunction in preclinical in vivo studies. METHODS: PubMed and EMBASE were systematically searched for preclinical in vivo interventional studies evaluating efficacy and safety of MSC treatment following radio-induced salivary gland damage published before 10th of January 2022. The primary endpoint was salivary flow rate (SFR) evaluated in a meta-analysis. The study protocol was published and registered on PROSPERO ( www.crd.ac.uk/prospero ), registration number CRD42021227336. RESULTS: A total of 16 preclinical in vivo studies were included for qualitative analysis (858 experimental animals) and 13 in the meta-analysis (404 experimental animals). MSCs originated from bone marrow (four studies), adipose tissue (10 studies) and salivary gland tissue (two studies) and were administered intravenously (three studies), intra-glandularly (11 studies) or subcutaneously (one study). No serious adverse events were reported. The overall effect on SFR was significantly increased with a standardized mean difference (SMD) of 6.99 (95% CI: 2.55-11.42). Studies reported improvements in acinar tissue, vascular areas and paracrine factors. CONCLUSION: In conclusion, this systematic review and meta-analysis showed a significant effect of MSC therapy for restoring SG functioning and regenerating SG tissue following radiotherapy in preclinical in vivo studies without serious adverse events. MSC therapy holds significant therapeutic potential in the treatment of radio-induced xerostomia, but comprehensive, randomized, clinical trials in humans are required to ascertain their efficacy in a clinical setting.

Physical activity monitoring-based interventions in geriatric patients: a scoping review on intervention components and clinical applicability.

OBJECTIVE: To identify and analyze the components applied in interventions using physical activity (PA) monitoring in geriatric patients and determine their feasibility and applicability. METHODS: A systematic search in six databases (PubMed, Embase, SPORTDiscus, CINAHL, Web of Science, and GeroLit) was conducted to identify studies reporting interventions that included the application of a PA monitor in adults aged ≥ 60 years with a clinical diagnosis. PA monitor interventions were analyzed regarding their feedback, goal-setting and behavior change technique (BCT) components. To determine the feasibility and applicability of interventions, the participants' adherence to the intervention, their experience as well as adverse events were analyzed. RESULTS: Seventeen eligible studies, applying 22 interventions, were identified. Studies included a total of 827 older patients with a median age of 70.2 years. In thirteen interventions (59%), the PA monitor was embedded in a structured behavioral intervention, an indication-specific intervention or usual care. Most frequently applied intervention components were goal setting and self-monitoring (n = 18), real-time PA monitor feedback complemented by feedback from the study team (n = 12), use of further BCTs (n = 18), and regular counseling with the study team (n = 19). Comprehensive information on the participants' intervention adherence and experience were reported for 15 (68%) and 8 (36%) interventions, respectively. CONCLUSION: The components included in PA monitoring-based interventions varied considerably especially regarding the extent, frequency, and content of feedback, goal setting and BCTs counseling. Future research should evaluate which components are most effective and clinically applicable to promote physical activity in geriatric patients. To be able to precisely analyze the effects, trials should seek to report details on intervention components, adherence and adverse events, while future reviews may use the findings of this scoping review to conduct analyses with less heterogeneity in study characteristics and intervention strategies.

Effectiveness of physical activity monitors in adults: systematic review and meta-analysis.

OBJECTIVE: To estimate the effectiveness of physical activity monitor (PAM) based interventions among adults and explore reasons for the heterogeneity. DESIGN: Systematic review and meta-analysis. STUDY SELECTION: The electronic databases MEDLINE, Embase, SPORTDiscus, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched on 4 June 2021. Eligible randomised controlled trials compared interventions in which adults received feedback from PAMs with control interventions in which no feedback was provided. No restrictions on type of outcome measurement, publication date, or language were applied. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed risk of bias. Random effects meta-analyses were used to synthesise the results. The certainty of evidence was rated by the Grading of Recommendations Assessment and Evaluation (GRADE) approach. MAIN OUTCOME MEASURES: The three primary outcomes of interest were physical activity, moderate to vigorous physical activity, and sedentary time. RESULTS: 121 randomised controlled trials with 141 study comparisons, including 16 743 participants, were included. The PAM based interventions showed a moderate effect (standardised mean difference 0.42, 95% confidence interval 0.28 to 0.55) on physical activity, equivalent to 1235 daily steps; a small effect (0.23, 0.16 to 0.30) on moderate to vigorous physical activity, equivalent to 48.5 weekly minutes; and a small insignificant effect (-0.12, -0.25 to 0.01) on sedentary time, equal to 9.9 daily minutes. All outcomes favoured the PAM interventions. CONCLUSIONS: The certainty of evidence was low for the effect of PAM based interventions on physical activity and moderate for moderate to vigorous physical activity and sedentary time. PAM based interventions are safe and effectively increase physical activity and moderate to vigorous physical activity. The effect on physical activity and moderate to vigorous physical activity is well established but might be overestimated owing to publication bias. STUDY REGISTRATION: PROSPERO CRD42018102719.

Mesenchymal stromal/stem cell therapy for radiation-induced salivary gland hypofunction in animal models: a protocol for a systematic review and meta-analysis.

BACKGROUND: Salivary gland (SG) hypofunction (objectively reduced saliva flow rate) and xerostomia (subjective sensation of dry mouth) are common and burdensome side effects of radiotherapy to the head and neck region. Currently, only sparse symptomatic treatment is available to ease the discomfort of xerostomia. The objective of this study is to assess the effect of mesenchymal stem cell (MSC) therapy on SG function after radiation-induced injury. METHODS: This systematic review will include animal intervention studies assessing efficacy and safety of MSCs in treating radiation-induced SG hypofunction. The primary outcome is the effect of MSC administration on salivary flow rates (SFR), by comparing treated groups to control groups when available. Secondary outcomes are morphological and immunohistochemical effects as well as safety of MSC treatment. Electronic searches in MEDLINE (PubMed) and Embase databases will be constructed and validated according to the peer review of electronic search strategies (PRESS) and assessed by two independent researchers. Data from eligible studies will be extracted, pooled, and analyzed using random-effects models. Risk of bias will be evaluated with the Systematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool. DISCUSSION: Thus far, critical appraisal of MSC therapy as an effective treatment for SG hypofunction caused solely by radiation injury has not been conducted. A summary of the existing literature on preclinical studies concerning this issue can provide valuable information about effectiveness, mode of action, and safety, allowing further optimization of preclinical and clinical trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021227336.

The MIPAM trial - motivational interviewing and physical activity monitoring to enhance the daily level of physical activity among older adults - a randomized controlled trial.

BACKGROUND: One in four older adults in Denmark and almost half of the very old above 75 do not meet the World Health Organization's recommendations for a minimum of physical activity (PA). A cost-efficient and effective way to increase focus on and motivation for daily walking might be to use Physical Activity Monitors (PAMs) in combination with behavioural change intervention. Thus, the objective of this randomized controlled study was to investigate the effect of Motivational Interviewing (MI) as an add-on intervention to a PAM-based intervention measured in community-dwelling older adults. METHODS: This two-arm parallel group randomized controlled effectiveness trial compared a 12-weeks PAM-based intervention with additional MI (PAM+MI group) with a PAM-based intervention alone (PAM group). The primary outcome, average daily step count, was analysed with a linear regression model, adjusted for sex and baseline daily step count. Following the intention-to-treat principle, multiple imputation based on baseline step count, sex and age was performed. RESULTS: In total, 38 participants were randomized to the PAM intervention and 32 to the PAM+MI intervention arm. During the intervention period, PAM+MI participants walked on average 909 more steps per day than PAM participants, however insignificant (95%CI: - 71; 1889) and reported 2.3 points less on the UCLA Loneliness Scale (95%CI: - 4.5; - 1.24). CONCLUSION: The use of MI, in addition to a PAM-based intervention among older adults in PA promoting interventions hold a potential clinically relevant effect on physical activity and should thus be investigated further with adequately powered RCTs. TRIAL REGISTRATION: This study was pre-registered in the clinicaltrials.gov database with identifier: NCT03906162 .

Lifestyle interventions after ablation for atrial fibrillation: a systematic review.

BACKGROUND: Risk factors of atrial fibrillation include diabetes, obesity and physical inactivity. Positive effects such as decreased atrial fibrillation burden have been reported for atrial fibrillation patients who have participated in lifestyle changing interventions after atrial fibrillation ablation treatment. AIM: The aim of this study was to assess the evidence on the benefits and harms of lifestyle and risk factor management interventions in patients undergoing atrial fibrillation ablation. METHOD: Our systematic review searched MEDLINE, EMBASE, CINAHL, Psychinfo, Web of Science and CENTRAL using key terms related to atrial fibrillation and lifestyle, including interventional trials. The primary outcomes were mortality and serious adverse events. Random effects meta-analyses of outcomes were conducted when appropriate. RESULTS: Two randomised controlled trials and two non-randomised interventional trials with a total of 498 patients were included. Six primary events were reported for the intervention groups and five events for the control groups (relative risk of 1.03, 95% confidence interval (CI) 0.3 to 3.1, I2 0%, P = 0.537). Effects in favour of the intervention groups were found for atrial fibrillation frequency (0.82 points, 95% CI -1.60 to -0.03, I2 87.3%, P = 0.005), atrial fibrillation duration (-0.76 points, 95% CI -1.64 to 0.12, I2 89.1%, P = 0.002) and body mass index (-5.40 kg/m2, 95% CI 6.22 to -2.57, I2 83.9%, P = 0.013). Risk of bias in the four studies was judged to be low to moderate. CONCLUSION: Lifestyle changing interventions seem to have a positive effect on outcomes relevant to patients undergoing atrial fibrillation ablation, but the included studies were small, interventions were inhomogeneous, and the quality of evidence was low to moderate. More studies are warranted.

Frailty Index Status of Canadian Home Care Clients Improves With Exercise Therapy and Declines in the Presence of Polypharmacy.

OBJECTIVE: This study aimed to investigate if exercise therapy and polypharmacy was associated with frailty state transitions for home care service recipients. DESIGN: Longitudinal cohort-study using client-level health information collected using interRAI home care (RAI-HC) assessments. SETTING: Population-based study with Canadian home care clients in Alberta, British Columbia, Ontario and the Yukon. PARTICIPANTS: Home care clients aged 65 years and older. METHODS: A Markov chain multistate transition logistic regression model was used to calculate ORs for state transitions with exercise therapy and polypharmacy as independent variables. RESULTS: In total, 250,428 home care clients experiencing 402,005 frailty state transitions were included in the analyses. At baseline, 39.4% of clients were categorized as nonfrail, 30.2% were categorized as prefrail, and 30.4% were categorized as frail. Nonfrail clients using polypharmacy were more likely to become prefrail (OR 1.16) and frail (OR 1.11). Pre-frail clients using polypharmacy were more likely to become frail (OR 1.06), and they were less likely to become nonfrail (OR 0.80). Frail clients using polypharmacy were significantly less likely to become prefrail (OR 0.82) or nonfrail (OR 0.62). Nonfrail clients who participated in exercise therapy were more likely to become prefrail (OR 1.05). Prefrail clients who participated in exercise therapy were more likely to become nonfrail (OR 1.26). Frail clients who participated in exercise therapy were more likely to become nonfrail (OR 1.27) and prefrail (OR 1.12). CONCLUSIONS AND IMPLICATIONS: This study suggests that frailty among home care clients can be reversed. Frailty state improvement occurred significantly more often among home care clients receiving exercise therapy and significantly less often among clients with polypharmacy.

Injuries in Novice Participants during an Eight-Week Start up CrossFit Program-A Prospective Cohort Study.

BACKGROUND: Previously published studies have reported injury rates ranging from 0.74 to 3.3 per 1000 h of exposure in CrossFit participants. However, the existing body of evidence is mainly based on experienced participants; therefore, the injury incidence and injury rate within novice CrossFit participants remains relatively unknown. The aim of this study wasto investigate the injury incidence and injury rate among novice participants in an eight-week CrossFit program. METHODS: This survey-based prospective cohort study included CrossFit Copenhagen's novice members who began an eight-week, free-of-charge membership period. A questionnaire was distributed at baseline and at eight-week follow-up. Information about exposure was retrieved through the online booking system. Injury incidence, defined as proportion of participants who sustained an injury, and injury rates per 1000 h of exposure were calculated. RESULTS: Among the 168 included participants, a total of 28 injuries (14.9%) were reported. The number of injured participants and total exposure time resulted in an injury rate per 1000 h of exposure of 9.5. CONCLUSIONS: Compared to the existing body of evidence, the findings in this study indicate that the risk of injuries is higher among novice participants than among experienced CrossFit participants.

Criterion validity for step counting in four consumer-grade physical activity monitors among older adults with and without rollators.

BACKGROUND: Few studies have investigated the measurement properties of consumer-grade physical activity monitors (PAMs) in older adults. Therefore, we investigated the criterion validity of consumer-grade PAMs in older adults and whether the measurement properties differed between older adults with and without rollators and whether worn on the hip or at the wrist. METHODS: Consumer-grade PAMs were eligible for inclusion in this study if they: 1) could be fastened at the hip as well as on the wrist, 2) were simple in function and design and thus easy to use for participants with minimal technical skills, 3) included step-counting as outcome measure and 4) were powered by a button cell battery. Participants performed self-paced walking for six minutes while two physiotherapists counted their steps with a click-counter. The average of the two counts was used as criterion. The participants wore 16 monitors, four located bilaterally on both hips and wrists. Our prior expectation was that all monitors would have at least moderate criterion validity for all participants, good criterion validity for participants walking without a rollator and poor criterion validity for participants walking with a rollator. RESULTS: Four physical activity monitors were included in this study; Misfit Shine, Nokia GO, Jawbone UP Move and Garmin Vivofit 3. A total of 103 older adults participated.Nokia GO was excluded from this study due to technical issues. Therefore, we present results on the frequency of data loss, ICC (1, 2) and percentage measurement error for Misfit Shine, Garmin Vivofit 3 and Jawbone UP Move located on four different positions. CONCLUSIONS: The hip-worn PAMs did not differ significantly in terms of measurement error or criterion validity. Wrist-worn monitors cannot adequately measure number of steps in a population of older adults using rollators. The hip-worn PAMs were superior to wrist-worn PAMs among older adults with and without rollators.

Physical activity monitors to enhance amount of physical activity in older adults - a systematic review and meta-analysis.

BACKGROUND: The body of evidence related to the effect of physical activity monitor-based interventions has grown over the recent years. However, the effect of physical activity monitor-based interventions in older adults remains unclear and should be systematically reviewed. OBJECTIVE: The objective of this systematic review was to estimate the effect of physical activity monitor-based interventions on physical activity behavior in participants aged 65 and above. Subsequently we explored the effect on body mass index, physical capacity, and health-related quality of life and finally the impact of patient- and intervention characteristics. METHODS: Searches in MEDLINE, EMBASE, SPORTDiscus, CINAHL, and CENTRAL were performed on April 26, 2018. No publication date filters were applied. References of eligible studies were scrutinized and relevant journals were hand-searched. Randomized controlled trials and randomized cross-over trials investigating the effect of a physical activity monitor-based intervention on physical activity were included. Studies were included if the mean age of the participants was above 65 years, and participants could walk independently with or without walking aids. The Cochrane handbook was used as a template for extracting data and the RoB 2.0 tool was used to assess risk of bias. Random-effects meta-analysis using Hedges g, were used to pool the study results. The main outcome of this study was physical activity. RESULTS: Twenty-one studies with 2783 participants were included. The median participant age in the studies was 70.5 years, the median percentage of male participants was 42%, and the median baseline daily step count was 5268. Physical activity monitor-based interventions had a moderate effect (SMD = 0.54, 95% CI: 0.34 to 0.73) compared to control interventions, corresponding to an average increase of 1297 steps per day in the intervention groups. No impact of patient and intervention characteristics on the effect estimates were found. SHORT CONCLUSION: Low quality of evidence was found for a moderate effect of physical activity monitor-based interventions on physical activity compared with control interventions. More studies with higher research methodology standards are required. PROSPERO REGISTRATION: CRD42018083648.

Feedback from physical activity monitors to enhance amount of physical activity in adults-a protocol for a systematic review and meta-analysis.

OBJECTIVE: The use of physical activity monitors (PAMs) in the adult population is increasing rapidly and previous systematic reviews are outdated. The objective of this systematic review and meta-analysis is to estimate the effect of PAM-based interventions on physical activity behavior in adults. Furthermore, the impact of intervention, study, and participants characteristics will be investigated. METHODS AND DESIGN: Randomized controlled trials and randomized cross-over trials including adult participants will be included if the study compares any PAM-based intervention where the participants receive feedback on their physical activity level measured by PAMs, to control interventions where participants do not receive feedback from PAMs. This protocol is detailed according to the recommendations of the Cochrane Handbook, and it is reported according to the preferred reporting items for systematic reviews and meta-analyses protocols statement. The results from the literature search will be presented in a PRISMA flow chart. The effects from individual studies will be summarized in a random effects meta-analysis and the impact of diagnosis of the participants, type of feedback, type of intervention, and control intervention will be investigated in stratified meta-analysis and meta-regressions analysis. The results on daily physical activity, moderate to vigorous physical activity, sedentary time, and adverse events will be presented in a summary of findings table. DISCUSSION: The results will be useful to researchers, policy makers, and health care professionals when the intention is to increase physical activity in the adult population. PROSPERO REGISTRATION: CRD42018102719.

Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes-A pilot randomized controlled trial.

OBJECTIVES: The objective was to investigate the feasibility and usability of electronic momentary assessment, goal-setting and personalized phone-calls on adherence to a 12-week self-conducted interval walking training (IWT) program, delivered by the InterWalk smartphone among patients with type 2 diabetes (T2D). METHODS: In a two-arm pilot randomized controlled trial (Denmark, March 2014 to February 2015), patients with T2D (18-80 years with a Body Mass Index of 18 and 40 kg/m2) were randomly allocated to 12 weeks of IWT with (experimental) or without additional support (control). The primary outcome was the difference between groups in accumulated time of interval walking training across 12 weeks. All patients were encouraged to use the InterWalk application to perform IWT for ≥90 minute/week. Patients in the experimental group made individual goals regarding lifestyle change. Once a week inquiries about exercise adherence was made using an ecological momentary assessment (EMA). In case of consistent self-reported non-adherence, the patients would receive a phone-call inquiring about the reason for non-adherence. The control group did not receive additional support. Information about training adherence was assessed objectively. Usability of the EMA was assessed based on response rates and self-reported satisfaction after 12-weeks. RESULTS: Thirty-seven patients with T2D (66 years, 65% female, hemoglobin 1Ac 50.3 mmol/mol) where included (n = 18 and n = 19 in experimental and control group, respectively). The retention rate was 83%. The experimental group accumulated [95%CI] 345 [-7, 698] minutes of IWT more than the control group. The response rate for the text-messages was 83% (68% for males and 90% for females). Forty-one percent of the experimental and 25% of the control group were very satisfied with their participation. CONCLUSION: The combination inquiry about adherence using EMA, goal-setting with the possibility of follow-up phone calls are considered feasible interventions to attain training adherence when using the InterWalk app during a 12-week period in patients with T2D. Some uncertainty about the effect size of adherence remains. TRIAL REGISTRATION: Clinicaltrials.gov NCT02089477.

Physical activity monitors to enhance the daily amount of physical activity in elderly-a protocol for a systematic review and meta-analysis.

BACKGROUND: To investigate the use of physical activity monitors (PAMs) for the elderly, the scientific literature should be systematically reviewed and the effect quantified, as the evidence seems inconclusive. METHODS AND DESIGN: Randomized controlled trials and randomized crossover trials, with participants with a mean age above 65 years, comparing any PAM intervention with other control interventions or no intervention, will be included. This protocol is detailed according to the recommendations of the Cochrane Handbook, and it is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement. RESULTS: We will present results from the search in a flow diagram. The results from the analyses will include regular meta-analyses, stratified analyses, and meta-regressions. The results on each outcome of interest will be presented in a summary of findings table. DISCUSSION: This paper will explore and analyze the heterogeneity of the results and try to identify variables that will enhance the effect of PAMs in elderly. The results will be useful to researchers working with elderly and/or PAMs, health care professionals working with elderly, and relatives together with the elderly themselves. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018083648 .

A SYSTEMATIC REVIEW AND META-ANALYSIS COMPARING CARDIOPULMONARY EXERCISE TEST VALUES OBTAINED FROM THE ARM CYCLE AND THE LEG CYCLE RESPECTIVELY IN HEALTHY ADULTS.

INTRODUCTION: The cardiopulmonary exercise test (CPET) assesses maximal oxygen uptake (VO2max) and is commonly performed on a leg cycle ergometer (LC). However, some individuals would rather perform the CPET on an arm cycle ergometer (AC). OBJECTIVE: The objectives of this study were to undertake a systematic review and meta-analysis of the difference in VO2max achieved by AC compared to LC in healthy adults and to explore factors that may be predictive of this difference. METHODS: MEDLINE, EMBASE, CINAHL, and PEDro were searched in April 2015. The differences in VO2max (ACLCdiff) were pooled across studies using random effects meta-analysis and three different methods were used to estimate the ratio between the values obtained from the tests (ACLCratio). RESULTS: This paper included 41 studies with a total of 581 participants. The mean ACLCdiff across studies was 12.5 ml/kg/min and 0.89 l/min with a mean ACLCratio of 0.70. The ACLCdiff was lower in studies with higher mean age and lower aerobic capacity. CONCLUSION: There is linear association between the AC and LC values in healthy adults. The AC values were on average 70% of the LC values. The magnitude of this difference appeared to be reduced in studies on older and less active populations. LEVEL OF EVIDENCE: 3a.