A qualitative evaluation of a clinic versus home exercise rehabilitation program for adults with multiple sclerosis: The tele-exercise and multiple sclerosis (TEAMS) study.

BACKGROUND: Substantial evidence supports therapeutic exercise for improving health and function in people with multiple sclerosis (MS). However, few studies have considered the patients' perspective. OBJECTIVE: This study explored perspectives of adults with MS following participation in a 3-month clinic- and home-based exercise rehabilitation program. METHODS: Twenty participants with MS were interviewed using a semi-structured interview guide on the design and implementation processes of the exercise programs as well as any perceived facilitators or barriers to exercise. Data analysis was conducted using a thematic analysis approach to generate themes from the transcribed interviews. RESULTS: Key facilitators of exercise for people with MS included perceived improvements in physical health and function, activity participation, and psychosocial health. Mismatched level of exercise with their stage of post-diagnosis and/or functional ability and limited human interaction emerged as barriers to exercise. CONCLUSIONS: Participation in the exercise program was a positive experience for people with MS. Despite the provision of a high level of adaptation and tailored exercise plan and delivery, self-directed exercise continued to present challenges for people with MS. Additionally, the importance of seeking cost-effective ways to maintain motivational support was implicit in participant responses. The findings provided an improved understanding of personal experiences and exercise perspectives that can inform future intervention strategies aimed at promoting sustained exercise participation.

Supporting successful recruitment in a randomized control trial comparing clinic and home-based exercise among adults with multiple sclerosis.

BACKGROUND: The Tele- Exercise and Multiple Sclerosis (TEAMS) study, funded by the Patient Centered Outcome Research Institute (PCORI), is a pragmatic, cluster randomized controlled trial aimed at comparing the effectiveness of a 12-week complementary and alternative medicine (CAM) program for people with multiple sclerosis (MS) delivered by a therapist at a clinic and the same program initiated by the participant at home using a tablet and pre-recorded videos. The 20-session CAM program consists of yoga, Pilates and dual tasking exercises. The study aimed to enroll 820 participants with MS living in Alabama, Mississippi and Tennessee. MAIN BODY: The information provided in this paper describes the strategies that led to the largest randomized controlled exercise trial ever conducted for people with multiple sclerosis. Specifically, the paper presents the result of incorporating stakeholder engagement, a novel participant recruitment method, to produce a successful recruitment outcome for a comparative effectiveness randomized controlled trial. This study used three tiers of engagement: panel members (9 members), clinical partners (88 occupational and physical therapists), and community organizations (6 non-profits). CONCLUSION: Engagement of the stakeholder panel, clinical partners and community organizations led to interest of over 1700 people with MS across three states in the Deep South (final enrollment was n = 837). The diversity of our stakeholder groups and their extensive reach into various communities were a critical aspect for achieving our target sample size. The recruitment numbers reflect the importance of involving multiple stakeholder groups at project inception, developing relationships over time, utilizing member strengths, and monitoring their engagement on a regular basis to ensure a meaningful experience for all involved. TRIAL REGISTRATION: NCT03117881. Registered 18 April 2017, https://clinicaltrials.gov/ct2/show/NCT03117881?term=tele+rehabilitation&cond=Multiple+Sclerosis&cntry=US&state=US%3AAL&draw=2&rank=1 .

The Tele Exercise and Multiple Sclerosis (TEAMS) study has been able to successfully screen over 1700 people with multiple sclerosis (MS) across three southern states (Alabama, Mississippi, Tenessee) largely due to the advice and input that the research team received from a stakeholder panel, clinic partners and community organizations. These groups met before the study was submitted for funding to the Patient-Centered Outcome Research Institute (PCORI), and was awarded in 2017. These engagement stages and framework established early in the study process were instrumental in generating strong enthusiasm for the study among various MS constituency groups. The feedback from our stakeholders, clinic partners, and community organizations led to the creation of a variety of recruitment methods (print material, email, social media, attendance at events, and health fairs) to connect with potential participants in a setting convenient within each location. In approximately 26 months, the study enrolled 837 participants with MS and baseline tested 759 individuals who participated in a rehabilitative exercise program at either a clinic site or in their home using a tablet that they were given (and kept) which included a set of preloaded videos. All milestones established by PCORI and research staff were met, leading to the largest exercise trail ever conducted with people with MS.

COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.

BACKGROUND: Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. OBJECTIVE: In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. METHODS: The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8" step, and a large-print 8" × 11" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. RESULTS: The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. CONCLUSIONS: This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. TRIAL REGISTRATION: ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18415.

Comparing the Convergent and Concurrent Validity of the Dynamic Gait Index with the Berg Balance Scale in People with Multiple Sclerosis.

Background: Recent clinical guidelines for adults with neurological disabilities suggest the need to assess measures of static and dynamic balance using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) as core outcome measures. Given that the BBS measures both static and dynamic balance, it was unclear as to whether either of these instruments was superior in terms of its convergent and concurrent validity, and whether there was value in complementing the BBS with the DGI. Objective: The objective was to evaluate the concurrent and convergent validity of the BBS and DGI by comparing the performance of these two functional balance tests in people with multiple sclerosis (MS). Methods: Baseline cross-sectional data on 75 people with MS were collected for use in this study from 14 physical therapy clinics participating in a large pragmatic cluster-randomized trial. Convergent validity estimates between the DGI and BBS were examined by comparing the partial Spearman correlations of each test to objective lower extremity functional measures (Timed Up and Go (TUG), Six-Minute Walk Test (6MWT), Timed 25-Foot Walk (T25FW) test) and the self-reported outcomes of physical functioning and general health using the 36-Item Short Form Health Survey (SF-36). Concurrent validity was assessed by applying logistic regression with gait disability as the binary outcome (Patient Determined Disease Steps (PDDS) as the criterion measure). The predictive ability of two models, a reduced/parsimonious model including the BBS only and a second model including both the BBS and DGI, were compared using the adjusted coefficient of determinations. Results: Both the DGI and BBS were strongly correlated with lower extremity measures overall as well as across the two PDSS strata with correlations. In PDDS ≤ 2, the difference in the convergence of BBS with TUG and DGI with TUG was -0.123 (95% CI: -0.280, -0.012). While this finding was statistically significant at a type 1 error rate of 0.05, it was not significant (Hommel's adjusted p-value = 0.465) after accounting for multiple testing corrections to control for the family-wise error rate. The BBS⁻SF-36 physical functioning correlation was at least moderate and significant overall and across both PDDS strata. However, the DGI⁻physical functioning score did not have a statistically significant correlation within PDDS ≤ 2. None of the differences in convergent and concurrent validity between the BBS and DGI were significant. The additional variation in 6MWT explained by the DGI when added to a model with the BBS was 7.78% (95% CI: 0.6%, 15%). Conclusions: These exploratory analyses on data collected in pragmatic real-world settings suggest that neither of these measures of balance is profoundly superior to the other in terms of its concurrent and convergent validity. The DGI may not have any utility for people with PDDS ≤ 2, especially if the focus is on mobility, but may be useful if the goal is to provide insight on lower extremity endurance. Further research leveraging longitudinal data from pragmatic trials and quasi-experimental designs may provide more information about the clinical usefulness of the DGI in terms of its predictive validity when compared to the BBS.

Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south.

Long-term exercise/rehabilitation is an integral component of the continual care for people with multiple sclerosis (MS). However, access to this care, which includes comprehensive exercise/rehabilitation services to people with MS, remains a significant challenge, especially in rural, low-income areas. Telerehabilitation, or what we refer to as teleexercise, can help fill service gaps for underserved MS populations in this region. This pragmatic, cluster randomized controlled effectiveness trial will compare a 12-week, 20 session complementary and alternative medicine (CAM) intervention composed of neurorehabilitative (functional) exercise, yoga and Pilates delivered at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology (TeleCAM), to the same intervention delivered in clinic by a therapist (DirectCAM). Eight hundred and twenty people with MS are being recruited across Alabama, Mississippi and Tennessee. Primary self-reported patient-centered health outcomes are: pain, fatigue, quality of life and physical activity. Secondary outcomes include four physical functioning measures: balance, endurance, gait, and strength. Each of these outcomes will be examined by age, race, sex, severity of MS and other demographics to determine if outcomes are beneficial across all groups (i.e., heterogeneity of treatment effect). The project is important to people with MS and/or caregivers because it aims to reduce their barriers to receiving exercise treatment and increases the convenience and appeal of such programs through technology. Clinical Trials.gov Identifier: NCT03117881.

Assessing relapse in multiple sclerosis questionnaire: results of a pilot study.

There is need for a brief but comprehensive objective assessment tool to help clinicians evaluate relapse symptoms in patients with multiple sclerosis (MS) and their impact on daily functioning, as well as response to treatment. The 2-part Assessing Relapse in Multiple Sclerosis (ARMS) questionnaire was developed to achieve these aims. Part 1 consists of 7 questions that evaluate relapse symptoms, impact on activities of daily living (ADL), overall functioning, and response to treatment for previous relapses. Part 2 consists of 7 questions that evaluate treatment response in terms of symptom relief, functioning, and tolerability. The ARMS questionnaire has been evaluated in 103 patients with MS. The most commonly reported relapse symptoms were numbness/tingling (67%), fatigue (58%), and leg/foot weakness (55%). Over half of patients reported that ADL or overall functioning were affected very much (47%) or severely (11%) by relapses. Prescribed treatments for relapses included intravenous and/or oral corticosteroids (87%) and adrenocorticotropic hormone (13%). Nearly half of patients reported that their symptoms were very much (33%) or completely resolved (16%) following treatment. The most commonly reported adverse events were sleep disturbance (45%), mood changes (33%), weight gain (29%), and increased appetite (26%). Systematic assessment of relapses and response to relapse treatment may help clinicians to optimize outcomes for MS patients.

Sex, attribution, and severity influence intervention decisions of informal helpers in domestic violence.

Most domestic violence (DV) researchers examine professional intervention (e.g., police and nurses), but informal helpers (e.g., friends and bystanders) are critical. The authors measure undergraduates' intervention likelihood, type of involvement (i.e., contact with abuser), and the influence of attribution decisions in DV situations where the abuser's sex is manipulated. Self-esteem and other personal variables are not found to be influential, but participants intervene more when the abuser is male and if they have experienced childhood abuse. The influence of attributions in DV situations is influenced by the sex of the attacker and severity of the attack. Participants' attributions for male attackers predict intervention in severe cases of DV; attributions of drunkenness predict more intervention. In general, informal male helpers choose more risky types of intervention than female helpers do, and more aggressive individuals choose less helpful behaviors than those lower in aggression. Stigma reduction associated with DV and intervention, especially among male victims, and the importance of encouraging appropriate involvement among helpers are discussed.