Myths and methodologies: The use of equivalence and non-inferiority tests for interventional studies in exercise physiology and sport science.

Exercise physiology and sport science have traditionally made use of the null hypothesis of no difference to make decisions about experimental interventions. In this article, we aim to review current statistical approaches typically used by exercise physiologists and sport scientists for the design and analysis of experimental interventions and to highlight the importance of including equivalence and non-inferiority studies, which address different research questions from deciding whether an effect is present. Initially, we briefly describe the most common approaches, along with their rationale, to investigate the effects of different interventions. We then discuss the main steps involved in the design and analysis of equivalence and non-inferiority studies, commonly performed in other research fields, with worked examples from exercise physiology and sport science scenarios. Finally, we provide recommendations to exercise physiologists and sport scientists who would like to apply the different approaches in future research. We hope this work will promote the correct use of equivalence and non-inferiority designs in exercise physiology and sport science whenever the research context, conditions, applications, researchers' interests or reasonable beliefs justify these approaches.

Experiencing eight psychotherapy approaches devoted to eating disorders in a single-day workshop increases insight and motivation to engage in care: a pilot study.

PURPOSE: For patients with eating disorders (EDs), early engagement in care is usually considered a positive prognostic factor. The aim of the study was to investigate how a single-day intervention devoted to early, brief, experiential exposure to a variety of psychotherapy approaches might support commitment to change and the decision to engage in care in patients with EDs. METHODS: One hundred and sixty-nine adult outpatients newly diagnosed with an ED took part in a single-day workshop for groups of up to ten patients, where they experienced eight psychotherapeutic approaches. Motivation to change care and level of insight were assessed at baseline and 10 days after the intervention. RESULTS: Motivation and commitment to take active steps toward change (expressed by the "Committed Action" composite score) significantly improved after the intervention (p < 0.001), and a significant number of patients specifically moved from "contemplation" to "action" stage (p < 0.001). The improvement of motivation to change was significantly associated with an increase in insight capacity (p < 0.001), and this increase was observed for almost all related dimensions such as recognition of illness or awareness of need for psychological treatment. CONCLUSION: A single-day session devoted to experiencing a range of group psychotherapies increased patients' insight and motivation to actively engage in care. To confirm potential longer-term benefits of this intervention, further studies are needed to explore the contribution of each approach and process specifically involved in patients' increased motivation for care, as well as the clinical characteristics of patients associated with better outcomes. LEVEL OF EVIDENCE: V: Opinions of respected authorities, based on descriptive studies, narrative reviews, clinical experience, or reports of expert committees.

Are web-based personally tailored physical activity videos more effective than personally tailored text-based interventions? Results from the three-arm randomised controlled TaylorActive trial.

OBJECTIVES: Some online, personally tailored, text-based physical activity interventions have proven effective. However, people tend to 'skim' and 'scan' web-based text rather than thoroughly read their contents. In contrast, online videos are more engaging and popular. We examined whether web-based personally tailored physical activity videos were more effective in promoting physical activity than personally tailored text and generic information. METHODS: 501 adults were randomised into a video-tailored intervention, text-tailored intervention or control. Over a 3-month period, intervention groups received access to eight sessions of web-based personally tailored physical activity advice. Only the delivery method differed between intervention groups: tailored video versus tailored text. The primary outcome was 7-day ActiGraph-GT3X+ measured moderate-to-vigorous physical activity (MVPA) assessed at 0, 3 and 9 months. Secondary outcomes included self-reported MVPA and website engagement. Differences were examined using generalised linear mixed models with intention-to-treat and multiple imputation. RESULTS: Accelerometer-assessed MVPA increased 23% in the control (1.23 (1.06, 1.43)), 12% in the text-tailored (1.12 (0.95, 1.32)) and 28% in the video-tailored (1.28 (1.06, 1.53)) groups at the 3-month follow-up only, though there were no significant between-group differences. Both text-tailored (1.77 (1.37, 2.28]) and video-tailored (1.37 (1.04, 1.79)) groups significantly increased self-reported MVPA more than the control group at 3 months only, but there were no differences between video-tailored and text-tailored groups. The video-tailored group spent significantly more time on the website compared with text-tailored participants (90 vs 77 min, p=0.02). CONCLUSIONS: The personally tailored videos were not more effective than personally tailored text in increasing MVPA. The findings from this study conflict with pilot study outcomes and previous literature. Process evaluation and mediation analyses will provide further insights. TRIAL REGISTRATION NUMBER: ACTRN12615000057583.

A randomized controlled trial of a forgiveness intervention program with female acid attack survivors in Pakistan.

Despite the traumatic effects of acid violence on its victims, treatment options are very limited. The present study was aimed at examining the efficacy of a forgiveness intervention with female survivors of acid attack violence in Pakistan. Female acid attack victims in Pakistan were randomized to either a forgiveness group (n = 8) or a treatment-as-usual (TAU; n = 8) control group. The forgiveness group received twice-a-week forgiveness sessions for 4 months, whereas the TAU group either received typical psychological treatment sessions for acid attack victims or no treatment. All participants were assessed on their levels of forgiveness, anger, anxiety, depression, and hope four times prior to the 4-month intervention period, twice after the intervention period, and once at the 1-year follow-up. Posttreatment, the forgiveness intervention group showed greater improvement in hope, anger, anxiety, and depression when compared with the TAU group. Upon further examinations, both groups improved on forgiveness from pretreatment to posttreatment, but the forgiveness group had a higher baseline. From pretreatment to the 12-month follow-up, the forgiveness group, when compared with the TAU group, showed greater improvement in all areas except for depression. This is the first study that examined the effects of a forgiveness intervention for acid attack victims in Pakistan. Results showing the improvement posttreatment as well as over a 1-year period posttreatment are encouraging.

Forty-five per cent lower acute injury incidence but no effect on overuse injury prevalence in youth floorball players (aged 12-17 years) who used an injury prevention exercise programme: two-armed parallel-group cluster randomised controlled trial.

OBJECTIVE: To study whether an injury prevention exercise programme would reduce the number of injuries in youth floorball players. METHODS : 81 youth community level floorball teams (48 clusters=clubs) with female and male players (12-17 years) were cluster-randomised into an intervention or control group. Intervention group coaches were instructed to use the Swedish Knee Control programme and a standard running warm-up before every training session, and the running warm-up before every match, during the season. Control teams continued usual training. Teams were followed during the 2017/2018 competitive season (26 weeks). Player exposure to floorball and occurrence of acute and overuse injuries were reported weekly via a web-based player survey using the Oslo Sports Trauma Research Centre Questionnaire. RESULTS : 17 clusters (301 players) in the intervention group and 12 clusters (170 players) in the control group were included for analyses. There were 349 unique injuries in 222 players. The intervention group had a 35% lower incidence of injuries overall than the control group (adjusted incidence rate ratio (IRR) 0.65, 95% CI 0.52 to 0.81). The absolute risk reduction was 6.6% (95% CI 3.2 to 10.0), and the number needed to treat was 152 hours of floorball exposure (95% CI 100 to 316). Intervention group teams had a 45% lower incidence of acute injuries (adjusted IRR 0.55, 95% CI 0.37 to 0.83). There was no difference in the prevalence of overuse injuries (adjusted prevalence rate ratio 0.96, 95% CI 0.73 to 1.26). CONCLUSION : The Knee Control injury prevention programme reduced acute injuries in youth floorball players; there was no effect on overuse injuries. TRIAL REGISTRATION NUMBER: Clinical Trials NCT03309904.

Injection therapies for plantar fasciopathy ('plantar fasciitis'): a systematic review and network meta-analysis of 22 randomised controlled trials.

OBJECTIVE: To compare the efficacy of different injection therapies for plantar fasciopathy (historically known as 'plantar fasciitis'). DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Electronic databases (MEDLINE, CENTRAL, Web of Science and Scopus) were searched up to 11 July 2015 for completed studies. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We considered randomised trials comparing various injection therapies in adults with plantar fasciopathy. The primary outcome was pain relief. Secondary outcomes included functional disability, composite and health-related outcomes. All outcomes were assessed (1) in the short term (up to 2 months), (2) the intermediate term (2-6 months) and (3) the medium term (more than 6 months to 2 years). Quality assessment was performed using the Cochrane risk of bias tool. RESULTS: We included 22 trials comprising 1216 patients. Dehydrated amniotic membrane injections were significantly superior to corticosteroids in the short term in achieving the primary and composite outcomes (mean difference (MD) in visual analogue scale (VAS) was -7.32, 95% CIs -11.2 to -3.38; and MD in the foot health status questionnaire was 31.2, 95% CIs 13.9 to 48.6, respectively). For pain relief, botulinum toxin-A provided a significant short-term advantage over placebo, which was still present at 6 months (MD in VAS was -2.9, 95% CIs -4.44 to -1.39; and MD -4.34, 95% CIs -7.18 to -1.54, respectively). SUMMARY: Although the dehydrated amniotic membrane provided significant clinical relief at 0-2 months, there were no data about this treatment at 2 months and beyond. Botulinum toxin-A injections significantly reduced pain intensity at 0-6 months. SYSTEMATIC REVIEW REGISTRATION NUMBER: CRD42015017353.

Aerobic exercise ameliorates cognitive function in older adults with mild cognitive impairment: a systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate the effect of aerobic exercise on cognitive function in people with mild cognitive impairment (MCI). DESIGN: Systematic review and meta-analysis of aerobic exercise intervention for cognitive function in older adults with MCI. DATA SOURCES: PubMed, EMBASE, SinoMed, China National Knowledge Infrastructure (CNKI), Wanfang and Chinese Science and Technology Periodical (VIP) databases from their inception to 31 January 2015, the Cochrane Central Register of Controlled Trials (Cochrane Library, 2015, Issue 3) and the reference lists of all retrieved articles. ELIGIBILITY CRITERIA: Randomised controlled trials, older adults with MCI, aerobic exercises compared with no specific exercise intervention for global cognitive ability and any specific domains of cognition. DATA SYNTHESIS: Meta-analysis was conducted with RevMan V.5.3 software using the fixed-effect model for the available data without significant heterogeneity, or the random-effect model was used if appropriate. RESULTS: 11 studies were identified involving 1497 participants. Meta-analysis showed that aerobic exercise significantly improved global cognitive ability (Mini-Mental State Examination (MMSE) scores: MD=0.98, 95% CI 0.5 to 1.45, p<0.0001; Montreal Cognitive Assessment (MoCA) scores: MD=2.7, 95% CI 1.11 to 4.29, p=0.0009); weakly, positively improve memory (immediately recall: SMD=0.29, 95% CI 0.13 to 0.46, p=0.0005; delay recall: SMD=0.22, 95% CI 0.09 to 0.34, p=0.0005). No significant improvement was found in other domains of cognition. CONCLUSIONS: Aerobic exercise led to an improvement in global cognitive ability and had a positive effect with a small effect size on memory in people with MCI. However, owing to the limitations of the included studies, these findings should be interpreted cautiously.

Ultrasound-guided shoulder girdle injections are more accurate and more effective than landmark-guided injections: a systematic review and meta-analysis.

OBJECTIVE: To compare the accuracy and efficacy of ultrasound (US)-guided injections versus landmark-guided injections of the subacromial space, biceps tendon sheath, acromioclavicular (AC) joint and glenohumeral (GH) joint. METHODS: PubMed, Medline and Cochrane libraries were searched up to 31 July 2013. Two independent authors selected and evaluated randomised controlled trials comparing the accuracy and/or efficacy of US versus landmark-guided injection of the shoulder girdle. A meta-analysis of accuracy, pain Visual Analog Scale (VAS), function score and reported adverse events were performed. RESULT: Four cadaveric studies (300 cadaveric shoulders) and nine live human studies (514 patients) were reviewed. Based on three studies for AC joint, the accuracy of US versus a landmark-guided injection was 93.6% vs 68.2% (p<0.0001). Based on single studies, the accuracy of US versus a landmark-guided injection was 65% vs 70% for the subacromial space (p>0.05), 86.7% vs 26.7% for the biceps tendon sheath (p<0.05), and 92.5% vs 72.5% for the GH joint (p=0.025). Based on three studies for the subacromial space, the US group had a significantly greater reduction in pain (mean difference (MD)=1.47, 95% CI 1.0 to 1.93), and improvement in function (standardised MD=0.70, 95% CI 0.39 to 1.01) at 6 weeks postinjection. Based on a single study for the biceps tendon sheath, the US group had a significantly greater reduction in pain (MD 1.9, 95% CI 1.2 to 2.6) and improvement in function (MD=10.9, 95% CI 6.57 to 15.23). CONCLUSIONS: US-guided injections showed greater accuracy for all shoulder girdle injections, with the exception of the subacromial space. There was improved efficacy for the subacromial space and biceps tendon sheath injections.

The efficacy of a supervised and a home-based core strengthening programme in adults with poor core stability: a three-arm randomised controlled trial.

BACKGROUND: Poor core stability is linked to a range of musculoskeletal pathologies and core-strengthening programmes are widely used as treatment. Treatment outcomes, however, are highly variable, which may be related to the method of delivery of core strengthening programmes. We investigated the effect of identical 8 week core strengthening programmes delivered as either supervised or home-based on measures of core stability. METHODS: Participants with poor core stability were randomised into three groups: supervised (n=26), home-based (n=26) or control (n=26). Primary outcomes were the Sahrmann test and the Star Excursion Balance Test (SEBT) for dynamic core stability and three endurance tests (side-bridge, flexor and Sorensen) for static core stability. The exercise programme was devised and supervised by an exercise physiologist. RESULTS: Analysis of covariance on the change from baseline over the 8 weeks showed that the supervised group performed significantly better on all core stability measures than both the home-based and control group. The home-based group produced significant improvements compared to the control group in all static core stability tests, but not in most of the dynamic core stability tests (Sahrmann test and two out of three directions of the SEBT). CONCLUSIONS: Our results support the use of a supervised core-strengthening programme over a home-based programme to maximise improvements in core stability, especially in its dynamic aspects. Based on our findings in healthy individuals with low core stability, further research is recommended on potential therapeutic benefits of supervised core-strengthening programmes for pathologies associated with low core stability. TRIAL REGISTRATION NUMBER: ACTRN12613000233729.

Patellar taping for patellofemoral pain: a systematic review and meta-analysis to evaluate clinical outcomes and biomechanical mechanisms.

OBJECTIVE: Patellar taping is frequently used to treat patellofemoral pain (PFP). This systematic review and meta-analysis (1) evaluates the efficacy of patellar taping for patients with PFP, (2) compares the efficacy of various taping techniques and (3) identifies potential biomechanical mechanisms of action. METHODS: The MEDLINE, CINAHL, SPORTSDiscus, Web of Science and Google Scholar databases were searched in January 2013 for studies evaluating the effects of patellar taping on pain and lower-limb biomechanics in individuals with PFP. Three independent reviewers assessed each paper for inclusion and two assessed for quality. Means and SDs were extracted from each included study to allow effect size calculations. RESULTS: Twenty studies were identified. There is moderate evidence that (1) tailored (customised to the patient to control lateral tilt, glide and spin) and untailored patellar taping provides immediate pain reduction of large and small effect, respectively and (2) tailored patellar taping promotes earlier onset of vastus medialis oblique (VMO) contraction (relative to vastus lateralis contraction). There is limited evidence that (1) tailored patellar taping combined with exercise provides superior pain reduction compared to exercise alone at 4 weeks, (2) untailored patellar taping added to exercise at 3-12 months has no benefit and (3) tailored patellar taping promotes increased internal knee extension moments. CONCLUSIONS: Tailoring patellar taping application (ie, to control lateral tilt, glide and spin) to optimise pain reduction is important for efficacy. Evaluation of tailored patellar taping beyond the immediate term is limited and should be a research priority. Possible mechanisms behind patellar taping efficacy include earlier VMO onset and improved knee function capacity (ie, ability to tolerate greater internal knee extension moments).

Strong evidence against platelet-rich plasma injections for chronic lateral epicondylar tendinopathy: a systematic review.

BACKGROUND: Chronic lateral epicondylar tendinopathy is frequent in athletes, and platelet-rich plasma (PRP) is being used increasingly in its treatment. OBJECTIVE: To systematically review the literature on the efficacy of PRP injections for chronic lateral epicondylar tendinopathy. METHODS: The databases of PubMed, EMBASE, CINAHL, Medline OvidSP, Scopus, Google Scholar, Web of Science and Cochrane Library were searched in October 2013. Inclusion criteria were a clinical diagnosis of chronic lateral epicondylar tendinopathy, a randomised controlled trial, an intervention with a PRP injection and the outcome measures described in terms of pain and/or function. One author screened the search results and two authors independently assessed the study quality using the Physiotherapy Evidence Database (PEDro) score. A study was considered to be of high quality if its PEDro score was ≥6. A best evidence synthesis was used to identify the level of evidence. RESULTS: 6 studies were included, of which four were considered to be of high quality. Three high-quality studies (75%) and two low-quality studies showed no significant benefit at the final follow-up measurement or predefined primary outcome score when compared with a control group. One high-quality study (25%) showed a beneficial effect of a PRP injection when compared with a corticosteroid injection (corticosteroid injections are harmful in tendinopathy). Based on the best evidence synthesis, there is strong evidence that PRP injections are not efficacious in chronic lateral epicondylar tendinopathy. CONCLUSIONS: There is strong evidence that PRP injections are not efficacious in the management of chronic lateral elbow tendinopathy.

Attention to principles of exercise training: a review of exercise studies for survivors of cancers other than breast.

OBJECTIVES: Randomised controlled trials (RCTs) can evaluate how well a particular exercise programme reduces cancer treatment-related side effects. Adequate design and reporting of the exercise prescription employed in RCTs is central to interpreting study findings and translating effective interventions into practice. Our previous review on the quality and reporting of exercise prescriptions in RCTs in breast cancer survivors revealed several inadequacies. This review similarly evaluates exercise prescriptions used in RCTs in patients with cancers other than the breast. METHODS: The literature was searched for RCTs in persons diagnosed with a cancer other than breast. Data were extracted to evaluate the attention to the principles of exercise training in the study design and the reporting of and adherence to the exercise prescription used for the intervention. RESULTS: Of the 33 studies reviewed, none attended to all of the exercise training principles. Specificity was applied by 89%, progression by 26%, overload by 37%, initial values by 26%, diminishing returns by 9% and reversibility by 3%. Only 2 of 33 studies (6%) reported both the exercise prescription in full and adherence to each individual component of the prescription. CONCLUSIONS: Application of the principles of training in exercise RCTs of non-breast cancer survivors was incomplete and inconsistent. Given these observations, interpretation of findings from the reviewed studies should consider potential shortcomings in intervention design. Though the prescribed exercise programme was often described, adherence to the entire prescription was rarely reported providing a less accurate picture of dose-response and challenges in translating programmes to community settings.

A knowledge transfer scheme to bridge the gap between science and practice: an integration of existing research frameworks into a tool for practice.

Evidence of effectiveness does not equal successful implementation. To progress the field, practical tools are needed to bridge the gap between research and practice and to truly unite effectiveness and implementation evidence. This paper describes the Knowledge Transfer Scheme integrating existing implementation research frameworks into a tool which has been developed specifically to bridge the gap between knowledge derived from research on the one side and evidence-based usable information and tools for practice on the other.

Physical activity during pregnancy and the risk of gestational diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials.

OBJECTIVES: We performed a systematic review and meta-analysis to assess the effects of physical activity in preventing gestational diabetes mellitus (GDM). SEARCH STRATEGY: We searched the literature in six electronic databases and bibliographies of relevant articles. SELECTION CRITERIA: We included randomised controlled trials on pregnant women who did not have GDM and other complications previously and had increased physical activity as the only intervention. The risk of developing GDM was documented separately for the intervention and control groups. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data and assessed quality independently. Data from the included trials were combined using a fixed-effects model. The effect size was expressed as relative risk (RR) and 95% CI. MAIN RESULTS: Of the 1110 studies identified, six randomised controlled trials met the inclusion criteria. In three trials, the incidence of GDM was lower in the intervention group than in the control group, whereas two trials showed a higher incidence of GDM in the intervention group and the remaining trial found no GDM in either the intervention or control group. The meta-analysis resulted in a relative risk (RR) of GDM of 0.91 (95% CI 0.57 to 1.44), suggesting no significant difference in the risk of developing GDM between the intervention and the control groups. No indication of publication bias was found. CONCLUSIONS: Evidence was insufficient to suggest that physical activity during pregnancy might be effective to lower the risk of developing GDM.

ACTIVEDEP: a randomised, controlled trial of a home-based exercise intervention to alleviate depression in middle-aged and older adults.

OBJECTIVE: To evaluate the efficacy of a home-based exercise programme added to usual medical care for the treatment of depression. DESIGN: Prospective, two group parallel, randomised controlled study. SETTING: Community-based. PATIENTS: 200 adults aged 50 years or older deemed to be currently suffering from a clinical depressive illness and under the care of a general practitioner. INTERVENTIONS: Participants were randomly allocated to either usual medical care alone (control) or usual medical care plus physical activity (intervention). The intervention consisted of a 12-week home-based programme to promote physical activity at a level that meets recently published guidelines for exercise in people aged 65 years or over. MAIN OUTCOME MEASUREMENTS: Severity of depression was measured with the structured interview guide for the Montgomery-Asberg Depression Rating Scale (SIGMA), and depression status was assessed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). RESULTS: Remission of depressive illness was similar in both the usual care (59%) and exercise groups (63%; OR = 1.18, 95% CI 0.61 to 2.30) at the end of the 12-week intervention, and again at the 52-week follow-up (67% vs 68%) (OR=1.07, 95% CI 0.56 to 2.02). There was no change in objective measures of fitness over the 12-week intervention among the exercise group. CONCLUSIONS: This home-based physical activity intervention failed to enhance fitness and did not ameliorate depressive symptoms in older adults, possibly due to a lack of ongoing supervision to ensure compliance and optimal engagement.

Empowering Movement: Enhancing Young Adults' Physical Activity through Self-Determination Theory and Acceptance and Commitment Therapy-Based Intervention.

OBJECTIVE: This study aims to investigate the effectiveness of a combined Self-Determination Theory (SDT) and Acceptance and Commitment Therapy (ACT) intervention, the "Running Minds" program, in promoting physical activity (PA) among young adults. METHODS: The intervention, consisting of eight sessions, targeted motivational and psychological barriers to PA. It intertwined SDT's core components (autonomy, competence, relatedness) with ACT's emphasis on mindfulness and value-driven actions. This study used a qualitative approach, collecting data through semi-structured interviews with twelve participants aged 20-35, conducted post-intervention. RESULTS: Our reflexive thematic analysis of the interviews revealed five key themes: alignment with personal values, rewarding experience of the sessions, fulfillment of social connectedness, enhancement of both intrinsic and extrinsic motivation, and observable behavioral changes. These findings highlight the importance of aligning exercise with personal values and the role of supportive social environments in sustaining PA. CONCLUSIONS: The integration of SDT and ACT in the "Running Minds" program appears to be a viable approach for enhancing motivation and adherence to PA among young adults. This study offers valuable insights for future PA interventions, underscoring the need for strategies that consider psychological and social dimensions. Limitations and Future Research: Despite the promising results, limitations include potential recall bias and the short duration of the study. Further research, especially focusing on more diverse groups and employing longitudinal designs, is recommended to broaden and substantiate these findings.

Effects of a multidisciplinary intervention to promote physical activity in patients with stroke undergoing rehabilitation: study protocol for the ActivePAS pilot randomised controlled trial.

Introduction: Physical activity after stroke is related to functional recovery and outcomes. To optimise physical activity adapted to a patient's walking ability and characteristics, multidisciplinary support and interventions are required. The Activate Physical Activity for Stroke pilot randomised controlled trial aims to assess the safety and feasibility of a multidisciplinary intervention that promotes physical activity in patients who had a stroke undergoing rehabilitation. Methods and analysis: This single-centre, randomised controlled trial will enrol 32 patients who had a stroke undergoing rehabilitation. Patients who had a stroke with the ability to walk 50 m with at least hand assistance, regardless of the use of braces or walking aids, and aged≥20 years will be randomly allocated to a multidisciplinary intervention group or control group. Patients in the intervention group will receive instructions for the self-monitoring of hospitalised physical activity and support to promote physical activity by multidisciplinary staff. The primary outcome of the present study is the safety (adverse events) and feasibility (retention and completion rates) of the multidisciplinary intervention. We assess physical activity using a triaxial accelerometer (UW-204NFC, A&D Company) as one of the secondary outcomes. Ethics and dissemination: The present study has been approved by the Research Ethics Committee of Konan Women's University and the Ethics Committee of Nishi-Kinen Port Island Rehabilitation Hospital. We will disseminate the results of the present study through a peer-reviewed manuscript and presentations at international conferences. Trial registration number: UMIN000046731.