Implementing Physical Activity Guidelines for Adults With MS

NCT02100020 | Completed

• 1 other identifier: MSProject2001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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

Keywords

physical activity; exercise guidelines; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physical Fitness

  At baseline and after the 16 week intervention

• Perceived Quality of Life

  At baseline and after the 16 week intervention

• Fatigue

  At baseline and after the 16 week intervention

• Mobility

  At baseline and after the 16 week intervention

• Blood markers of cardiovascular disease risk

  At baseline and after the 16 week intervention

Study Arms (2)

Direct Referral to Physical Activity

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Direct Referral to physical activity 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.

Direct Referral to Physical Activity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

McMaster University, Physical Activity Centre for Excellence

Hamilton, Ontario, L8S 4K1, Canada

Location

Queens University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 31675636 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Audrey L Hicks, Ph.D.

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 31, 2014
• Study Start: May 1, 2014
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

CA (2)