Implementing Physical Activity Guidelines for Adults With MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100020
• Other study ID #: MSProject2001
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University, Physical Activity Centre for Excellence	Hamilton	Ontario
Canada	Queens University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

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