Multiple SclerosisNCT02100020
Implementing Physical Activity Guidelines for Adults With MS
A study testing Direct Referral to physical activity in people with Multiple Sclerosis, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Direct Referral to physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesCanada
- Study dates
- May 2014to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of MS with mild-moderate disability (EDSS 1-7)
- Aged 18-60
- Medical clearance to participate in physical activity
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University, Physical Activity Centre for Excellence
Hamilton, Ontario, L8S 4K1
Queens University
Kingston, Ontario, K7L 3N6
About this study
Official title: A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.
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
- Being tested
- Direct Referral to physical activity
- Keywords
- physical activity, exercise guidelines, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Referral to physical activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (5)
Physical Fitness
Peak oxygen uptake, maximum muscle strength, bodyweight
Measured: At baseline and after the 16 week intervention
Perceived Quality of Life
Multiple Sclerosis Quality of Life (MSQoL) scale
Measured: At baseline and after the 16 week intervention
Fatigue
Multiple Sclerosis Fatigue Impact Scale (MSFIS)
Measured: At baseline and after the 16 week intervention
Mobility
25ft walk test
Measured: At baseline and after the 16 week intervention
Blood markers of cardiovascular disease risk
blood lipid panel, HbA1c, fasting glucose
Measured: At baseline and after the 16 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey L Hicks, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100020
- Sponsor's protocol ID
- MSProject2001
- Status last verified
- May 2018
- First submitted
- 24 Mar 2014
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT02100020
- Acronym / sponsor ID
- MSProject2001
- Conditions
- Multiple Sclerosis
- Keywords
- physical activity, exercise guidelines, multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Referral to Physical Activity | Experimental | Other: Direct Referral to physical activityThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of MS with mild-moderate disability (EDSS 1-7)
- Aged 18-60
- Medical clearance to participate in physical activity
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Referral to physical activityParticipants 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. | Other | Direct Referral to Physical Activity |
Primary outcome
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.
5 secondary outcomes
Physical Fitness
Time frame: At baseline and after the 16 week intervention
Perceived Quality of Life
Time frame: At baseline and after the 16 week intervention
Fatigue
Time frame: At baseline and after the 16 week intervention
Mobility
Time frame: At baseline and after the 16 week intervention
Blood markers of cardiovascular disease risk
Time frame: At baseline and after the 16 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Derived from this study: PubMed 31675636Canning 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey L Hicks, Ph.D. principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Referral to physical activity in people with Multiple Sclerosis, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Physical Activity Guidelines (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018; AzTrials last refreshed its copy on 3 Nov 2026.