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Multiple Sclerosis and Pilates

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ClinicalTrials.gov Identifier: NCT03006900
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
Multiple Sclerosis Society of Canada
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Pilates Other: Massage Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining the Impact of a Pilates Program in Multiple Sclerosis
Study Start Date : December 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilates and massage
Pilates (twice per week for 50 minutes) and massage (once per week for one hour)
Other: Pilates
Pilates

Other: Massage
Massage

Active Comparator: Massage
Massage (once per week for one hour)
Other: Massage
Massage




Primary Outcome Measures :
  1. Change from baseline in distance during the 6-minute walk test [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in balance score for the Fullerton Advanced Balance Scale [ Time Frame: 12 weeks ]
  2. Change in sit and reach test score for flexibility [ Time Frame: 12 weeks ]
  3. Change from baseline in timed up and go test score [ Time Frame: 12 weeks ]
  4. Change from baseline in physical activity level [ Time Frame: 12 weeks ]
  5. Change from baseline in maximal isometric knee extension strength [ Time Frame: 12 weeks ]
  6. Change from baseline in ability to recruit motor units [ Time Frame: 12 weeks ]
  7. Change from baseline in ability to recruit motor units in a fatigued state [ Time Frame: 12 weeks ]
  8. Change from baseline in trunk muscular endurance [ Time Frame: 12 weeks ]
  9. Change from baseline in lean tissue mass [ Time Frame: 12 weeks ]
  10. Change from baseline in fat mass [ Time Frame: 12 weeks ]
  11. Change from baseline for score from the MS International Quality of Life questionnaire [ Time Frame: 12 weeks ]
  12. Change from baseline in adverse events [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of multiple sclerosis

Exclusion Criteria:

  • Expanded Disability Status Scale of 8 or higher

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006900


Locations
Canada, Saskatchewan
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5B2
Sponsors and Collaborators
University of Saskatchewan
Multiple Sclerosis Society of Canada
Investigators
Principal Investigator: Charity Evans, PhD University of Saskatchewan

Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03006900     History of Changes
Other Study ID Numbers: 2918
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases