Multiple Sclerosis and Pilates

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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT03006900
• Other Study ID Numbers: 2918
• First Posted: December 30, 2016
• 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:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases