Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS)
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|ClinicalTrials.gov Identifier: NCT04027114|
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Individualized behavioural physical activity intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial|
|Estimated Study Start Date :||July 12, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||March 2022|
|Experimental: Behavioural Physical Activity (PA) intervention||
Behavioral: Individualized behavioural physical activity intervention
• The intervention involves a tailored physiotherapy (PT) intake that will serve as the foundation for the individualized approach. Participants' individual attributes and physical activity needs, including a general PT assessment will occur initially. Over the next 12 months, participants will receive individualized PT coaching and a physical activity plan plus access to educational literature that outlines methods and benefits of exercise. An estimated 15 hours of PT contact hours per participant is anticipated and the specifics of each encounter will be documented.
|No Intervention: Wait list control|
- Godin Leisure Time Exercise Questionnaire (GLTEQ) Score [ Time Frame: baseline to 12 months ]change in physical activity level. The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active.
- Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2) [ Time Frame: baseline to 12 months ]change in patient-reported disease-related symptoms measured using MSIS-29 v2 scale. MSIS-29 assess the impact of MS on health related quality of life in terms of physical and psychological well-being. The MSIS-29 v2 is a 29 item self-administered questionnaire. 20 items are associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 4 response options: 1 "not at all" to 4"extremely". Min score=29, max =116 with a higher value indicating more severely impacted
- Multiple Sclerosis Self Efficacy Scale (MSSE) [ Time Frame: baseline to 12 months ]change in patient-reported level of confidence regarding components of disease management. The MSSE has 18 items represented by two subscales of Function (9 items) and Control (9 items). Participants rate their confidence from 10-100 where 10 has an anchor of very uncertain, 50 moderately certain, and 100 very certain. A higher score meaning more confident/higher self-efficacy.
- Interviews and Exit surveys [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control) group ]experience of participants and interventionists
- Intervention Description [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control group) ]a description of interventionist contact time with participant and frequency, method and types of services provided
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027114
|University of Saskatchewan|
|Saskatoon, Saskatchewan, Canada, S7N 2Z4|