Clinical trial NCT03827928: LoveYourBrain Yoga for Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Fatigue
Anxiety
Depression
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
2. 18 years of age or older
3. Ability to ambulate without assistance from a device or person
4. Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
5. Able to read, write, and speak English
6. Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
7. Willing and able to give informed consent

Exclusion Criteria:

1. Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
2. MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
3. Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
4. 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.
5. 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.

Primary outcomes:
measure: Feasibility of conducting a yoga intervention study
timeFrame: At the clinic visit immediately following the yoga class session
Secondary outcomes:
measure: Change in subject self-rated fatigue
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated self-efficacy
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated anxiety
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated depression
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated positive affect
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject cognition/processing speed
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated sleep disturbance
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated pain interference
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated quality of life
timeFrame: Through study completion, approximately 22 weeks
measure: Change in subject self-rated cognitive function
timeFrame: Through study completion, approximately 22 weeks
measure: Satisfaction rating of 6-week yoga program on a scale of 1 - 10
timeFrame: At the clinic visit immediately following the yoga/meditation class session
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: