Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Fakolade A

PROVIDER: S-EPMC10622616 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Fakolade Afolasade A Awadia Zain Z Cardwell Katherine K McKenna Odessa O Venasse Myriam M Hume Taylor T Ludgate Julia J Freedman Mark S MS Finlayson Marcia M Latimer-Cheung Amy E AE Pilutti Lara A LA

Contemporary clinical trials communications 20231016

<h4>Background</h4>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.<h4>Methods</h4>A randomized controlled feasibility trial, with 1:1 allocation into the intervention or wait-list control condi ...[more]

PMID: 37928934

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Project description:ObjectivesTo develop We Walk, a theoretically informed, 12-week person-centred dyadic behaviour change intervention to increase physical activity (PA) in community-dwelling people with stroke (PWS) through outdoor walking.DesignThree-phase intervention development study. Phase 1: we reviewed literature on barriers and facilitators to PA after stroke and mapped them to the Behaviour Change Wheel and Theoretical Domains Framework to define intervention components. The Health Action Process Approach determined intervention structure underpinned by person-centred principles. Phase 2: stakeholder focus groups involving PWS, their companions and health professionals reviewed the draft intervention, and experts in behaviour change were consulted. Phase 3: informed by phases 1 and 2, the intervention and form of delivery were refined, with final review through patient and public involvement.SettingThree Scottish community rehabilitation stroke services.ParticipantsTwenty-three ambulatory community-dwelling PWS and their companions, thirty-seven health and exercise professionals, seven behaviour change experts.ResultsPhase 1 determined key intervention components: information about benefits of walking; developing motivation and confidence to walk; facilitating dyadic goal setting and making plans together; monitoring walking, overcoming challenges; and maintaining walking behaviour. Phase 2 review by stakeholder focus groups and behaviour change experts endorsed intervention components and structure, emphasising dyadic relational aspects as central to potential success. In phase 3, intervention content and handbooks for PWS and buddies were finalised. Healthcare professionals proposed third-sector delivery as most appropriate for intervention delivery. A detailed delivery manual was developed. Participants preferred facilitated face-to-face and telephone delivery.ConclusionsOur multilens intervention development approach ensured this novel intervention was evidence-informed, person-centred, theoretically coherent provided appropriate social support, and addressed issues of concern to PWS. This study established intervention components and structure and identified operational issues critical to future success. Future research will pilot and refine We Walk and evaluate acceptability, feasibility, effectiveness and cost-effectiveness.Trial registration numberISRCTN34488928.

Project description:IntroductionAlthough physical activity may reduce disease burden, fatigue and disability, and improve quality of life among people with multiple sclerosis (MS), many people with MS are physically inactive and spend significant time in sedentary behaviour. Behaviour change interventions may assist people with MS to increase physical activity and reduce sedentary behaviour. However, few studies have investigated their effectiveness using objective measures of physical activity, particularly in the long term. Further, interventions that have proven effective in the short term may not be feasible in clinical practice because of the large amount of support provided. The iStep-MS trial aims to determine the safety, feasibility and acceptability of a behaviour change intervention to increase physical activity and reduce sedentary behaviour among people with MS.Methods and analysisSixty people with MS will be randomised (1:1 ratio) to receive a 12-week intervention or usual care only. The intervention consists of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Outcomes assessed at baseline, 12 weeks and 9 months are physical activity (ActiGraph wGT3X-BT accelerometer), sedentary behaviour (activPAL3µ), self-reported activity and sitting time, walking capability, fatigue, self-efficacy, participation, quality of life and health service use. The safety of the intervention will be determined by assessing change in pain and fatigue and the incidence of adverse events during the follow-up period. A parallel process evaluation will assess the feasibility and acceptability of the intervention through assessment of fidelity to the programme and semistructured interviews exploring participants' and therapists' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on quality of life and resource use.Ethics and disseminationResearch ethics committee approval has been granted from Brunel University London. Results of the trial will be submitted for publication in journals and distributed to people with MS and physiotherapists.Trial registration numberISRCTN15343862 (doi 10.1186/ISRCTN15343862). Protocol version: 1.0; Pre-results.

Project description:BackgroundEvidence for benefits of physical activity after stroke is unequivocal. However, many people with stroke are inactive, spending > 80% of waking hours sedentary even when they have physical capacity for activity, indicating barriers to physical activity participation that are not physical. WeWalk is a 12-week person-centred dyadic behaviour change intervention in which a person with stroke (PWS) and a walking buddy form a dyad to work together to support the PWS to increase their physical activity by walking outdoors. This pilot study examined the feasibility of recruiting dyads, explored their perceptions of acceptability and their experiences using WeWalk, to identify required refinements before progression to a clinical trial.MethodsDesign: A single-arm observational pilot study with qualitative evaluation.InterventionWeWalk involved facilitated face-to-face and telephone sessions with a researcher who was also a behaviour change practitioner, supported by intervention handbooks and diaries, in which dyads agreed walking goals and plans, monitored progress, and developed strategies for maintaining walking.EvaluationDescriptive data on recruitment and retention were collected. Interview data were collected through semi-structured interviews and analysed using thematic analysis, guided by a theoretical framework of acceptability.ResultsWe recruited 21 dyads comprising community dwelling PWS and their walking buddies. Ten dyads fully completed WeWalk before government-imposed COVID-19 lockdown. Despite lockdown, 18 dyads completed exit interviews. We identified three themes: acceptability evolves with experience, mutuality, and person-centredness with personally relevant tailoring. As dyads recognised how WeWalk components supported walking, perceptions of acceptability grew. Effort receded as goals and enjoyment of walking together were realised. The dyadic structure provided accountability, and participants' confidence developed as they experienced physical and psychological benefits of walking. WeWalk worked best when dyads exhibited relational connectivity and mutuality in setting and achieving goals. Tailoring intervention components to individual circumstances and values supported dyads in participation and achieving meaningful goals.ConclusionRecruiting dyads was feasible and most engaged with WeWalk. Participants viewed the dyadic structure and intervention components as acceptable for promoting outdoor walking and valued the personally tailored nature of WeWalk. Developing buddy support skills and community delivery pathways are required refinements. ISCTRN number: 34488928.

Project description:BackgroundMultiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive.Methods/designThis single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life.DiscussionPhysical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS.Trial registrationClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.

Project description:Background and purposeStroke survivors with type 2 diabetes mellitus (DM) face heightened cardiovascular risks, which are exacerbated by sedentary behaviour (SB). Despite existing interventions, there remains a gap in the literature regarding effective strategies to reduce SB and increase physical activity (PA). The purpose of this study was to explore the feasibility and safety of the 12-week 'Everyday Life is Rehabilitation' (ELiR) intervention comprising recruitment, adherence, practicality, and implementation into everyday life.MethodsSingle-group longitudinal intervention study with 1-week baseline, motivational interviews at weeks 1 and 6, and 12-week follow-up. Stroke survivors with DM (N = 14) were recruited from Neurovascular Center at Zealand University Hospital, Roskilde. The ELiR intervention is a theory-based intervention that focuses on healthcare professionals (HCP) consultations with stroke survivors with DM to address SB and PA. Primary outcomes were recruitment, adherence, completion of physical tests (accelerometer measurements), cognitive tests, and safety. Secondary outcomes were sedentary time and steps collected using an accelerometer and glycated haemoglobin (HbA1c) measurements.Results23 participants were recruited, of whom two were readmitted, one withdrew consent before the baseline test, and six were not discharged with a physiotherapy rehabilitation plan within 1-7 hospitalisation days. The remaining 14 were included and completed the study with a median modified Rankin scale (mRS) score of 1. The ELiR intervention revealed high adherence. Three participants experienced falls, and two were hospitalised. These incidents were not related to the intervention. Future adjustments include modified inclusion criteria, SMS-reminders, and point-of-care HbA1c measurements.DiscussionThe ELiR intervention was feasible and safe. Falls and serious adverse events are in line with previously reported risks. Self-reported questionnaires and clinical tests had low and moderate adherence, whereas accelerometers had high adherence. However, the small sample size limits generalisability, and adjustments to the ELiR intervention are suggested to improve usability in physiotherapy practice before testing in RCT studies to confirm these findings.

Project description:Physical activity (PA) is recommended as a key component in the management of people with rheumatoid arthritis (RA). The objective of this study was to examine the feasibility of a physiotherapist led, behaviour change (BC) theory-informed, intervention to promote PA in people with RA who have low levels of current PA. A feasibility randomised trial (ClinicalTrials.gov NCT03644160) of people with RA over 18 years recruited from outpatient rheumatology clinics and classified as insufficiently physically active using the Godin-Shephard Leisure Time Physical Activity Questionnaire. Participants were randomised to intervention group (4 BC physiotherapy sessions in 8 weeks) delivered in person/virtually or control group (PA information leaflet only). Feasibility targets (eligibility, recruitment, and refusal), protocol adherence and acceptability were measured. Health care professionals (HCPs) involved in the study and patients in the intervention and control arms were interviewed to determine acceptability. Descriptive statistics were used to analyse the data with SPSS (v27) with interviews analysed using content analysis using NVivo (v14). Three hundred and twenty participants were identified as potentially eligible, with n = 183 (57%) eligible to participate, of which n = 58 (32%) consented to participate. The recruitment rate was 6.4 per month. Due to the impact of COVID-19 on the study, recruitment took place over two separate phases in 2020 and 2021. Of the 25 participants completing the full study, 23 were female (mean age 60 years (SD 11.5)), with n = 11 allocated to intervention group and n = 14 to control. Intervention group participants completed 100% of sessions 1 & 2, 88% of session 3 and 81% of session 4. The study design and intervention were acceptable overall to participants, with enhancements suggested. The PIPPRA study to improve promote physical activity in people with RA who have low PA levels was feasible, acceptable and safe. Despite the impact of COVID-19 on the recruitment and retention of patients, the study provides preliminary evidence that this physiotherapist led BC intervention is feasible and a full definitive intervention should be undertaken. Health care professionals involved in the study delivery and the patient participants described a number of positive aspects to the study with some suggestions to enhance the design. These findings hence inform the design of a future efficacy-focused clinical trial.

Project description:ObjectivesThis study reports on the feasibility of the SitLess with MS trial, an intervention targeting sedentary behavior in individuals with multiple sclerosis (MS).DesignSingle group, pre-post intervention design.SettingCommunity.ParticipantsParticipants (N=41) with mild to moderate disability from MS.InterventionThe intervention was 15 weeks, with a 7-week follow-up, and included 2 stages: SitLess and MoveMore. During the SitLess stage, participants were encouraged to break up prolonged sitting bouts over a 7-week period, whereas the MoveMore stage promoted increased steps per day and interrupting sitting over a 7-week period. The intervention was delivered through weekly one-on-one coaching sessions via telerehabilitation and an accompanying newsletter based on social-cognitive theory. Activity was monitored throughout the program using a Fitbit.Main outcome measuresProcess (eg, recruitment) and resource and management (eg, personnel requirements) metrics were assessed, along with efficacy outcomes (eg, effect). Progression criteria were set a priori and were related to safety, fatigue, satisfaction, and attrition. Sedentary behavior, measured using the ActivPal, was reported pre- and postintervention, as well as 7 weeks postintervention. Effect sizes (pre to post, pre to 7 weeks post) were calculated for the sedentary behavior outcomes (eg, time sitting, transitions from sitting to standing, number of long sitting bouts). Experiences with the intervention were explored through an online survey.ResultsForty-one participants enrolled, 39 of whom completed the intervention. All participants but 1 were satisfied with the experience. Pre-post intervention effect sizes for change in total sedentary time, number of transitions from sit to stand, and number of long (>30 min) sedentary bouts were 0.34, 0.02, and 0.39 respectively. All a priori progression criteria were met.ConclusionsThe SitLess with MS program, a novel intervention that emphasized and facilitated sitting less and moving more, was feasible and resulted in small changes in sedentary behavior in individuals with MS.

Dataset Information

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

Background

Methods

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

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