- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006900
Multiple Sclerosis and Pilates
June 27, 2018 updated by: Phil Chilibeck, University of Saskatchewan
Determining the Impact of a Pilates Program in Multiple Sclerosis
Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to the more traditional exercise programs.
Although somewhat limited, previous research has suggested Pilates may have some beneficial effects in MS.
This 12-week, single-blinded, randomized controlled study has one intervention group (Pilates and massage therapy) and one control group (massage therapy only).
The primary outcome of interest is the change in walking ability between groups.
Secondary outcomes include other measures of physical performance and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the recent 2015 MS Society of Canada MS Wellness Survey almost 25% of people indicated that they think physical activity is the most important area of wellness, yet physical inactivity is still common in individuals with multiple sclerosis (MS).
While some of this may be due to factors related to MS such as fatigue, pain, and physical restrictions, research has shown that exercise has beneficial effects on mobility, strength, balance, and overall quality of life.
However, because the symptoms of MS vary, there is not one optimal exercise program that exists.
Pilates may be a good exercise option for MS.
Pilates focuses on body positions and movement, with specific attention on the core (stomach or trunk) muscles.
Very few researchers have studied Pilates in MS, but those that have, noticed some improvements in walking, balance, and strength.
There were no negative effects reported from the Pilates exercises, and the exercises can be adapted for all levels of ability in MS.
We are interested in studying the effect of Pilates in MS.
To do this, we will recruit 30 people with MS to participate in this study.
Participants will be randomly put into either the Pilates group or the control group.
Those individuals in the Pilates group will attend two 50-minute Pilates classes twice weekly, plus receive a weekly 1-hour massage therapy session.
Individuals in the control group will only receive the weekly massage therapy session.
At the end of the study (12 weeks), we will look to see if there are any differences between the two groups in walking ability.
We will also compare other important outcomes such as muscle strength, balance, and quality of life between the two groups.
Results from this study may provide individuals with another exercise option to help manage their MS and improve their wellness.
Results will also be useful for organizations such as the MS Society to help make decisions about which programs and services to offer to individuals with MS.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology, University of Saskatchewan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of multiple sclerosis
Exclusion Criteria:
- Expanded Disability Status Scale of 8 or higher
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilates and massage
Pilates (twice per week for 50 minutes) and massage (once per week for one hour)
|
Pilates
Massage
|
Active Comparator: Massage
Massage (once per week for one hour)
|
Massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in distance during the 6-minute walk test
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in balance score for the Fullerton Advanced Balance Scale
Time Frame: 12 weeks
|
12 weeks
|
Change in sit and reach test score for flexibility
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in timed up and go test score
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in physical activity level
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in maximal isometric knee extension strength
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in ability to recruit motor units
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in ability to recruit motor units in a fatigued state
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in trunk muscular endurance
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in lean tissue mass
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in fat mass
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline for score from the MS International Quality of Life questionnaire
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in adverse events
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Charity Evans, PhD, University of Saskatchewan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
December 27, 2016
First Submitted That Met QC Criteria
December 27, 2016
First Posted (Estimate)
December 30, 2016
Study Record Updates
Last Update Posted (Actual)
June 28, 2018
Last Update Submitted That Met QC Criteria
June 27, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2918
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
University of JaenCompletedLow Back Pain | Mind-body Exercise | Pilates, Core Stability | Pilates ExerciseSpain
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-
Universidad de AntioquiaCompletedHealthy VolunteersColombia
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