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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006900
Other study ID # 2918
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date December 2017

Study information

Verified date June 2018
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of multiple sclerosis

Exclusion Criteria:

- Expanded Disability Status Scale of 8 or higher

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates
Pilates
Massage
Massage

Locations

Country Name City State
Canada College of Kinesiology, University of Saskatchewan Saskatoon Saskatchewan

Sponsors (2)

Lead Sponsor Collaborator
University of Saskatchewan Multiple Sclerosis Society of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in distance during the 6-minute walk test 12 weeks
Secondary Change from baseline in balance score for the Fullerton Advanced Balance Scale 12 weeks
Secondary Change in sit and reach test score for flexibility 12 weeks
Secondary Change from baseline in timed up and go test score 12 weeks
Secondary Change from baseline in physical activity level 12 weeks
Secondary Change from baseline in maximal isometric knee extension strength 12 weeks
Secondary Change from baseline in ability to recruit motor units 12 weeks
Secondary Change from baseline in ability to recruit motor units in a fatigued state 12 weeks
Secondary Change from baseline in trunk muscular endurance 12 weeks
Secondary Change from baseline in lean tissue mass 12 weeks
Secondary Change from baseline in fat mass 12 weeks
Secondary Change from baseline for score from the MS International Quality of Life questionnaire 12 weeks
Secondary Change from baseline in adverse events 12 weeks
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