The Acceptability, Feasibility, and Impact of a Group-based Yoga and Psychoeducation Program for Community-dwelling Adults With Multiple Sclerosis: A Randomized, Cross-over Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Feasibility of conducting a yoga intervention study
Study Overview
Brief Summary
The purpose of the study is to assess the feasibility of a 6-week yoga and meditation intervention for people with multiple sclerosis (MS). The study will evaluate the impact of the program on fatigue, anxiety, depression, positive affect, and other measures. A sub-study will collect brain images using MRI on 2 subjects before and after the intervention to identify potential biological markers of MS related-fatigue.
Detailed Description
This study will recruit 20 subjects with multiple sclerosis (MS) to participate in a 6-week yoga/meditation program. Subjects will be randomly assigned to one of two groups. The first group will complete the yoga/meditation classes, followed by a waiting period. The second group will go through a waiting period, followed by yoga/meditation classes. Two subjects assigned to classes during the first session will be selected to participate in an MRI sub-study to look for biomarkers of MS-associated fatigue. All subjects will complete questionnaires and assessments during 3 clinic visits - at baseline, in between the class sessions, and at the end of the study. Questionnaires will also be mailed to subjects 6 weeks after the last study visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
- •18 years of age or older
- •Ability to ambulate without assistance from a device or person
- •Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
- •Able to read, write, and speak English
- •Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
- •Willing and able to give informed consent
Exclusion Criteria
- •Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
- •MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
- •Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
- •Contraindication to scanning, including but not limited to ferromagnetic metal in the body, claustrophobia, inability to lie still or otherwise tolerate being in the scanner.
- •Pregnant women must be excluded from the imaging component of the study due to unknown but possible risk of fetal exposure to the scanner. Women of child-bearing potential will take a confidential pregnancy test immediately prior to each scan session.
Arms & Interventions
Yoga/meditation
A 6-week yoga/meditation intervention.
Intervention: Yoga/meditation (Behavioral)
Wait list
A wait list control period.
Outcomes
Primary Outcomes
Feasibility of conducting a yoga intervention study
Time Frame: At the clinic visit immediately following the yoga class session
The feasibility will be determined by the completion rates of the intervention. If fewer than 50% of subjects complete the intervention, it will be deemed unfeasible in the current format.
Secondary Outcomes
- Change in subject self-rated sleep disturbance(Through study completion, approximately 22 weeks)
- Change in subject self-rated fatigue(Through study completion, approximately 22 weeks)
- Change in subject self-rated anxiety(Through study completion, approximately 22 weeks)
- Change in subject self-rated depression(Through study completion, approximately 22 weeks)
- Change in subject self-rated pain interference(Through study completion, approximately 22 weeks)
- Change in subject self-rated cognitive function(Through study completion, approximately 22 weeks)
- Change in subject self-rated positive affect(Through study completion, approximately 22 weeks)
- Change in subject self-rated quality of life(Through study completion, approximately 22 weeks)
- Change in subject self-rated self-efficacy(Through study completion, approximately 22 weeks)
- Change in subject cognition/processing speed(Through study completion, approximately 22 weeks)
- Satisfaction rating of 6-week yoga program on a scale of 1 - 10(At the clinic visit immediately following the yoga/meditation class session)
Investigators
Andrew D. Smith III
Principal Investigator
Dartmouth-Hitchcock Medical Center