Physical activity together for MS (PAT-MS): Secondary outcomes of a randomized controlled feasibility trial.

BACKGROUND: Care partners provide essential care to those with multiple sclerosis (MS). Dyadic interventions promoting health behaviours have wide-reaching benefits for individuals with MS and their care partners. However, behavioural interventions to promote physical activity in patient-caregiver dyads have yet to be explored in an MS-specific context. This study examined the secondary outcomes of the "Physical Activity Together for Multiple Sclerosis (PAT-MS)" intervention, including dyadic adjustment, caregiving tasks, caregiver quality of life, coping, and MS impact in MS dyads. METHODS: A randomized controlled feasibility trial of the 12-week behavioural PAT-MS intervention. The Dyadic Adjustment Scale, Caregiving Tasks in MS Scale, Caregiver Quality of Life in MS Scale, Coping with MS Caregiving Inventory, and MS Impact Scale measured secondary outcomes of interest. Mixed-model ANOVAs were used to test changes in variables between groups (PAT-MS vs wait-list control) over time. RESULTS: 20 participants, including 10 people with MS (51.4 ± 10.1 years old; median patient-determined disease steps (PDDS) score= 4, IQR= 1.25) and 10 care partners (48.5 ± 12.1 years old) were recruited and randomized. There was no statistically significant effect of the intervention on any of the secondary outcomes (p= 0.67-1.00). However, large effect sizes and condition-by-time interaction effects indicated improvement in dyadic adjustment (d= 1.03, ηp2= 0.45), the criticism-coercion coping subscale (d= -0.93, ηp2= 0.49), and caregiving tasks (d= 1.05, ηp2= 0.52), specifically within psycho-emotional (d= 1.47, ηp2= 0.38) and socio-practical (d= 1.10, ηp2 =0.37) sub-domains of caregiving tasks after the PAT-MS intervention compared to the wait-list condition. CONCLUSION: While this pilot feasibility study was not powered based on the secondary outcomes herein, our findings indicate improvement in dyadic adjustment and emotional and social caregiving tasks, with reduced reliance on criticism-coercion coping in the PAT-MS group compared to controls following the intervention. Findings indicate that PAT-MS may improve dyadic psychosocial well-being of people with moderate-to-severe MS and their care partners, and this should be examined next in a fully-powered study.

Physical Activity Together for Multiple Sclerosis (PAT-MS): A randomized controlled feasibility trial of a dyadic behaviour change intervention.

Background: Many people with advanced multiple sclerosis (MS) and their care-partners do not engage in sufficient physical activity (PA) for health benefits. We developed "Physical Activity Together for MS (PAT-MS)", a 12-week dyadic behavioural intervention, to promote PA among these dyads. Herein, we evaluated the feasibility of PAT-MS before a definitive trial. Methods: A randomized controlled feasibility trial, with 1:1 allocation into the intervention or wait-list control condition. Predefined progression criteria included rates of recruitment, retention, safety, participant satisfaction and adherence. Changes in self-reported and accelerometer-measured PA were assessed at baseline and post-intervention using mixed-factor ANOVAs. Effects sizes were calculated as Cohen's d. Results: The recruitment rate (i.e., 20 participants in 10 months) was not acceptable. However, retention (80%) was acceptable. No serious adverse events were reported. There were high levels of participant satisfaction with the intervention (content (median = 6 out of 7), facilitator (median = 7 out of 7), and delivery (median = 5 out of 7)) and adherence (92% of the group sessions, 83% of the individual support calls, and 80% of the practice activities were completed). There were statistically significant time-by-condition interactions on self-reported PA, steps/day, and %wear time and minutes in sedentary behaviour, and moderate-to-vigorous PA from baseline to post-intervention in people with MS and their family care-partners. Conclusion: PAT-MS appears feasible, safe, and efficacious for PA promotion in MS dyads. We established effect size estimates to power a future definitive trial and identified necessary methodological changes to increase the efficiency of study procedures and improve the quality of the intervention. Trial registration: ClinicalTrials.gov NCT04267185; Registered February 12, 2020, https://clinicaltrials.gov/ct2/show/NCT04267185.

The MoxFo initiative - outcomes: Outcome measures in studies of exercise training in multiple sclerosis; scoping review of reviews and classification according to the ICF framework.

BACKGROUND: The number of published studies of exercise training in multiple sclerosis (MS) has grown exponentially with increasing numbers of outcomes capturing exercise effects. This has complicated the selection of relevant indicators and interpretation of intervention effects. OBJECTIVES: The Outcomes subgroup of the MoXFo initiative aimed to (1) identify outcome measures and biomarkers in studies of exercise training in MS; (2) systematically map retrieved outcomes to International Classification of Functioning, Disability and Health (ICF) categories; (3) identify gaps where relevant ICF categories have been omitted. METHODS: Electronic databases and registers were searched from 2010 to July 2020 to identify systematic reviews or meta-analyses of controlled trials of exercise training on any outcome in MS. Retrieved outcomes/biomarkers were mapped to the corresponding ICF category. RESULTS: Eighty-one review articles reporting 235 different outcomes were included. The outcomes corresponded to 15 chapters and 45 categories within the ICF. Outcomes mapped primarily to body function (30 categories) and activities and participation (9 categories) components. Few outcomes mapped to body structures (2 categories) or environmental factors (1 category). CONCLUSION: This sets the stage to develop a resource for researchers/clinicians that will aid in the selection of appropriate outcomes/biomarkers when examining exercise effects in MS.