Study design and setting
The IPAC-MS study is a prospective, single-blinded, parallel-group, randomized controlled trial, conducted in the Canadian province of Saskatchewan. The study is designed as a superiority trial, and is a collaborative effort of interdisciplinary researchers, clinicians, and patient and family advisors.
Study Participants
Participants will primarily be recruited through the Saskatchewan MS Drugs Program (SMSDP). The SMSDP is a provincial initiative created to oversee the application of all individuals applying for government coverage of a disease-modifying therapy for MS. At the time of enrollment in the SMSDP, individuals are offered the chance to consent to be contacted about participating in future MS-related research; those who consent are also asked to complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ).23-25 Approximately 50% of all applicants to the SMSDP have consented and completed the GLTEQ. Individuals with a GLTEQ <24 are considered not sufficiently active for substantial health benefits, and will be the primary cohort targeted for recruitment. If necessary, recruitment may also occur through the Saskatoon MS Clinic, the primary referral site for all Saskatchewan MS patients, and through local MS Society organizations.
Individuals greater than 18 years of age, with clinically definite MS, a Patient Determined Disease Steps score ≤6 (i.e. able to walk with or without aids),26 and who are estimated to not be sufficiently active enough for substantial health benefits (i.e. self-reported exercise <4 times weekly) are eligible for this study. Those who are unable to provide consent or deemed to have a moderate-high risk for exercise-related harm based on the Physical Activity Readiness Questionnaire (PAR-Q)27 will be excluded.
Randomisation and Blinding
All consenting participants who have completed a baseline assessment will be stratified into one of three categories based on their baseline GLTEQ score (<9, 9-17, ≥18). Participants from each of the three strata will be randomly assigned to either the intervention or control group by a centralized telephone request to a study coordinator not involved in data collection or analyses. Randomisation lists were computer-generated in blocks of 4 to help achieve balance in the groups. The randomisation list was created prior to participant recruitment by a research team member not involved in data collection or analyses. Given the nature of the intervention, only the outcome assessors involved in the data collection will be blinded to the study group.
Intervention and Control
The intervention is an individualized physical activity behaviour change program. The intervention will be delivered by neurophysiotherapists with expertise in MS over a 12-month period. Because each program is specifically created for each individual, components of the intervention may vary between participants. However, there are three consistent features: behavioural change strategies, recommendations for physical activity, and ongoing neurophysiotherapist support. After randomization, participants in the intervention group will undergo a tailored intake by a neurophysiotherapist, which will serve as the foundation for the individualized approach. At the initial intake, neurophysiotherapists will evaluate the participants’ individual attributes and physical activity needs in addition to a general physiotherapy assessment (e.g. MS symptoms and functional levels) to create personalised programs. This initial intake may occur over 1-3 sessions and in variable formats depending on the participants’ needs. To promote consistency, neurophysiotherapists will be trained in the Behaviour Change Wheel,28 the Behaviour Change Technique Taxonomy,14 and the Social Cognitive Theory of Behaviour Change, including correlates and determinants of physical activity behaviour in MS.20 All training of the neurophysiotherapists was done with a standardised program and delivered by the same instructor.
All physical activity recommendations made by the neurophysiotherapists will be based on established guidelines, existing resources, and individual participant needs. Best practice guidelines recommend individuals with MS who have mild to moderate disability work up to at least 30 minutes of moderate intensity aerobic activity 2 times per week, and resistance exercises for major muscle groups 2 times per week.29 Support from a neurophysiotherapist will be available to the intervention group throughout the study period. We have allotted 15 neurophysiotherapist contact hours per participant, and each encounter will be recorded (method of contact, service delivered, and time required) using standardised data collection forms. The neurophysiotherapist support may occur in-person, via telephone, web-based methods and/or Telehealth. The neurophysiotherapist will record the types of behaviour change strategies utilised with each participant according to the framework and descriptors from the Behaviour Change Technique Taxonomy.14 Intervention participants will also receive printed educational material from the MS Society of Canada on physical activity,29 diet,30 and stress management31 at 2, 4 and 8 months.
The control group will receive the same printed education material as the intervention group at 2, 4, and 8 months. Participants in the control group will not receive any individualized assessments or recommendations, nor will they have access to neurophysiotherapist support throughout the 12-month study period (Figure 1). At the end of the study, the control group participants will have the opportunity to receive the intervention; however, any results generated will not be part of the primary study analyses.