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OpenTrials
Completed

NCT Number: NCT02100020

Implementing Physical Activity Guidelines for Adults With MS

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Physical Activity Centre for Excellence, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adherence to the Physical Activity Guidelines

    Time frame: 3 years

    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 outcomes

  1. Physical Fitness

    Time frame: At baseline and after the 16 week intervention

    Peak oxygen uptake, maximum muscle strength, bodyweight

  2. Perceived Quality of Life

    Time frame: At baseline and after the 16 week intervention

    Multiple Sclerosis Quality of Life (MSQoL) scale

  3. Fatigue

    Time frame: At baseline and after the 16 week intervention

    Multiple Sclerosis Fatigue Impact Scale (MSFIS)

  4. Mobility

    Time frame: At baseline and after the 16 week intervention

    25ft walk test

  5. Blood markers of cardiovascular disease risk

    Time frame: At baseline and after the 16 week intervention

    blood lipid panel, HbA1c, fasting glucose

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2014
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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