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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

Tracking Information
First Submitted Date  ICMJE December 27, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date June 28, 2018
Study Start Date  ICMJE December 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2016)
Change from baseline in distance during the 6-minute walk test [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03006900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2016)
  • Change from baseline in balance score for the Fullerton Advanced Balance Scale [ Time Frame: 12 weeks ]
  • Change in sit and reach test score for flexibility [ Time Frame: 12 weeks ]
  • Change from baseline in timed up and go test score [ Time Frame: 12 weeks ]
  • Change from baseline in physical activity level [ Time Frame: 12 weeks ]
  • Change from baseline in maximal isometric knee extension strength [ Time Frame: 12 weeks ]
  • Change from baseline in ability to recruit motor units [ Time Frame: 12 weeks ]
  • Change from baseline in ability to recruit motor units in a fatigued state [ Time Frame: 12 weeks ]
  • Change from baseline in trunk muscular endurance [ Time Frame: 12 weeks ]
  • Change from baseline in lean tissue mass [ Time Frame: 12 weeks ]
  • Change from baseline in fat mass [ Time Frame: 12 weeks ]
  • Change from baseline for score from the MS International Quality of Life questionnaire [ Time Frame: 12 weeks ]
  • Change from baseline in adverse events [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Sclerosis and Pilates
Official Title  ICMJE Determining the Impact of a Pilates Program in Multiple Sclerosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Other: Pilates
    Pilates
  • Other: Massage
    Massage
Study Arms  ICMJE
  • Experimental: Pilates and massage
    Pilates (twice per week for 50 minutes) and massage (once per week for one hour)
    Interventions:
    • Other: Pilates
    • Other: Massage
  • Active Comparator: Massage
    Massage (once per week for one hour)
    Intervention: Other: Massage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of multiple sclerosis

Exclusion Criteria:

  • Expanded Disability Status Scale of 8 or higher
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03006900
Other Study ID Numbers  ICMJE 2918
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Phil Chilibeck, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Multiple Sclerosis Society of Canada
Investigators  ICMJE
Principal Investigator: Charity Evans, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP