CClinicalTrials.gg
CompletedNCT02100020Updated May 31, 2018

Implementing Physical Activity Guidelines for Adults With MS

An interventional study of Direct Referral to physical activity in Multiple Sclerosis, sponsored by McMaster University. Completed at 2 sites in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by McMaster University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • physical activity
  • exercise guidelines
  • multiple sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 94 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    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.

    Other: Direct Referral to physical activity

  • No intervention
    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.

Interventions

  • OtherDirect 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.

06

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. Physical Fitness

    Peak oxygen uptake, maximum muscle strength, bodyweight

    Time frame: At baseline and after the 16 week intervention

  2. Perceived Quality of Life

    Multiple Sclerosis Quality of Life (MSQoL) scale

    Time frame: At baseline and after the 16 week intervention

  3. Fatigue

    Multiple Sclerosis Fatigue Impact Scale (MSFIS)

    Time frame: At baseline and after the 16 week intervention

  4. Mobility

    25ft walk test

    Time frame: At baseline and after the 16 week intervention

  5. Blood markers of cardiovascular disease risk

    blood lipid panel, HbA1c, fasting glucose

    Time frame: At baseline and after the 16 week intervention

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Study locations

2 sites
  • McMaster University, Physical Activity Centre for Excellence
    Hamilton, Ontario L8S 4K1, Canada
  • Queens University
    Kingston, Ontario K7L 3N6, Canada
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References and documents

Publications

  • 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. PubMed 31675636 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02100020
Lead sponsor
McMaster University
Responsible party
Sponsor
First posted
Mar 31, 2014
Start date
May 2014
Primary completion
Mar 31, 2018
Completion
Mar 31, 2018
Last update
May 31, 2018

Study contacts

Audrey L Hicks, Ph.D.
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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