Implementing Physical Activity Guidelines for Adults With MS

A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.

The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.

This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Direct Referral to physical activity

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University, Physical Activity Centre for Excellence
    • Kingston, Ontario, Canada, K7L 3N6
      • Queens University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of MS with mild-moderate disability (EDSS 1-7)
• Aged 18-60
• Medical clearance to participate in physical activity

Exclusion Criteria:

• current participation in regular physical activity (at least twice-weekly)
• other serious medical condition that might impair ability to participate in strength or aerobic exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct Referral to Physical Activity; The REF group will be referred to a centre-based community exercise program in their respective community (either the MacWheelers or Revved Up) by a clinical neurologist where they will be prescribed exercise based on the PAGs for adults with MS, and according to their individual capabilities.	Other: Direct Referral to physical activity; Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
No Intervention: Control; The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the Physical Activity Guidelines	Adherence to the physical activity guidelines will be analyzed by having participants fill in a weekly physical activity log that will be sent to them by email.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Fitness	Peak oxygen uptake, maximum muscle strength, bodyweight	At baseline and after the 16 week intervention
Perceived Quality of Life	Multiple Sclerosis Quality of Life (MSQoL) scale	At baseline and after the 16 week intervention
Fatigue	Multiple Sclerosis Fatigue Impact Scale (MSFIS)	At baseline and after the 16 week intervention
Mobility	25ft walk test	At baseline and after the 16 week intervention
Blood markers of cardiovascular disease risk	blood lipid panel, HbA1c, fasting glucose	At baseline and after the 16 week intervention

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Audrey L Hicks, Ph.D., McMaster University

Publications and helpful links

General Publications

• Canning KL, Hicks AL. Physician referral improves adherence to the physical activity guidelines for adults with MS: A randomized controlled trial. Mult Scler Relat Disord. 2020 Jan;37:101441. doi: 10.1016/j.msard.2019.101441. Epub 2019 Oct 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; multiple sclerosis; exercise guidelines
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MSProject2001