Implementing Physical Activity Guidelines for Adults With MS

NCT ID: NCT02100020

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-03-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Direct Referral to physical activity

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audrey L Hicks, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University, Physical Activity Centre for Excellence

Hamilton, Ontario, Canada

Queens University

Kingston, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 31675636 (View on PubMed)

Other Identifiers

MSProject2001

Identifier Type: -

Identifier Source: org_study_id