Clinical trial NCT03006900: Multiple Sclerosis and Pilates
Official title: Determining the Impact of a Pilates Program in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society of Canada
First posted: 2016-12-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis

Exclusion Criteria:

* Expanded Disability Status Scale of 8 or higher

Primary outcomes:
measure: Change from baseline in distance during the 6-minute walk test
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in balance score for the Fullerton Advanced Balance Scale
timeFrame: 12 weeks
measure: Change in sit and reach test score for flexibility
timeFrame: 12 weeks
measure: Change from baseline in timed up and go test score
timeFrame: 12 weeks
measure: Change from baseline in physical activity level
timeFrame: 12 weeks
measure: Change from baseline in maximal isometric knee extension strength
timeFrame: 12 weeks
measure: Change from baseline in ability to recruit motor units
timeFrame: 12 weeks
measure: Change from baseline in ability to recruit motor units in a fatigued state
timeFrame: 12 weeks
measure: Change from baseline in trunk muscular endurance
timeFrame: 12 weeks
measure: Change from baseline in lean tissue mass
timeFrame: 12 weeks
measure: Change from baseline in fat mass
timeFrame: 12 weeks
measure: Change from baseline for score from the MS International Quality of Life questionnaire
timeFrame: 12 weeks
measure: Change from baseline in adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Kinesiology, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Charity Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References: