Back to results

Implementing Physical Activity Guidelines for Adults With MS

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Direct Referral to physical activity

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring physical activity, exercise guidelines, multiple sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McMaster University, Physical Activity Centre for Excellence
Queens University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Direct Referral to Physical Activity

Control

Arm Description

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.

The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical Fitness

Peak oxygen uptake, maximum muscle strength, bodyweight

Perceived Quality of Life

Multiple Sclerosis Quality of Life (MSQoL) scale

Fatigue

Multiple Sclerosis Fatigue Impact Scale (MSFIS)

Mobility

25ft walk test

Blood markers of cardiovascular disease risk

blood lipid panel, HbA1c, fasting glucose

Full Information

NCT ID

NCT02100020

First Posted

March 24, 2014

Last Updated

May 29, 2018

Sponsor

McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT02100020

Brief Title

Implementing Physical Activity Guidelines for Adults With MS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

March 31, 2018 (Actual)

Study Completion Date

March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

physical activity, exercise guidelines, multiple sclerosis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct Referral to Physical Activity

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

The CON group will be provided with a print copy of the PAGs and a link to an online resource for physical activity information.

Intervention Type

Other

Intervention Name(s)

Direct Referral to physical activity

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adherence to the Physical Activity Guidelines

Description

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Physical Fitness

Description

Peak oxygen uptake, maximum muscle strength, bodyweight

Time Frame