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Multiple Sclerosis and Pilates

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pilates
Massage
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of multiple sclerosis

Exclusion Criteria:

  • Expanded Disability Status Scale of 8 or higher

Sites / Locations

  • College of Kinesiology, University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pilates and massage

Massage

Arm Description

Pilates (twice per week for 50 minutes) and massage (once per week for one hour)

Massage (once per week for one hour)

Outcomes

Primary Outcome Measures

Change from baseline in distance during the 6-minute walk test

Secondary Outcome Measures

Change from baseline in balance score for the Fullerton Advanced Balance Scale
Change in sit and reach test score for flexibility
Change from baseline in timed up and go test score
Change from baseline in physical activity level
Change from baseline in maximal isometric knee extension strength
Change from baseline in ability to recruit motor units
Change from baseline in ability to recruit motor units in a fatigued state
Change from baseline in trunk muscular endurance
Change from baseline in lean tissue mass
Change from baseline in fat mass
Change from baseline for score from the MS International Quality of Life questionnaire
Change from baseline in adverse events

Full Information

First Posted
December 27, 2016
Last Updated
June 27, 2018
Sponsor
University of Saskatchewan
Collaborators
Multiple Sclerosis Society of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03006900
Brief Title
Multiple Sclerosis and Pilates
Official Title
Determining the Impact of a Pilates Program in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Multiple Sclerosis Society of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates and massage
Arm Type
Experimental
Arm Description
Pilates (twice per week for 50 minutes) and massage (once per week for one hour)
Arm Title
Massage
Arm Type
Active Comparator
Arm Description
Massage (once per week for one hour)
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention Description
Pilates
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
Massage
Primary Outcome Measure Information:
Title
Change from baseline in distance during the 6-minute walk test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in balance score for the Fullerton Advanced Balance Scale
Time Frame
12 weeks
Title
Change in sit and reach test score for flexibility
Time Frame
12 weeks
Title
Change from baseline in timed up and go test score
Time Frame
12 weeks
Title
Change from baseline in physical activity level
Time Frame
12 weeks
Title
Change from baseline in maximal isometric knee extension strength
Time Frame
12 weeks
Title
Change from baseline in ability to recruit motor units
Time Frame
12 weeks
Title
Change from baseline in ability to recruit motor units in a fatigued state
Time Frame
12 weeks
Title
Change from baseline in trunk muscular endurance
Time Frame
12 weeks
Title
Change from baseline in lean tissue mass
Time Frame
12 weeks
Title
Change from baseline in fat mass
Time Frame
12 weeks
Title
Change from baseline for score from the MS International Quality of Life questionnaire
Time Frame
12 weeks
Title
Change from baseline in adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of multiple sclerosis Exclusion Criteria: Expanded Disability Status Scale of 8 or higher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charity Evans, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Kinesiology, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Multiple Sclerosis and Pilates

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