LoveYourBrain Yoga for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827928
• Other study ID #: D19058
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Yoga/meditation
A 6-week yoga and meditation program with psychoeducation components, delivered through community-based yoga sessions. This program offers structured instruction: 10 minutes of breathing exercises to calm the nervous system, 45 minutes of gentle yoga to improve strength, flexibility, and balance, 15 minutes of guided meditation to enhance attention control, emotional regulation, and self-efficacy, and 20 minutes of facilitated discussion with psychoeducation to build community connection and skills in resilience.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of conducting a yoga intervention study	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.	At the clinic visit immediately following the yoga class session
Secondary	Change in subject self-rated fatigue	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale for MS: 8-item measure of fatigue. Scale range 8 to 40. A lower score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated self-efficacy	Liverpool Self-efficacy scale: 17-item measure of self-efficacy. Scale range 17 to 68. A higher score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated anxiety	Neuro-Quality of Life (QOL) v1.0 Anxiety - Short Form: 8-item measure of anxiety. Scale range 8 to 40. A lower score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated depression	Neuro-Quality of Life (QOL) v1.0 Depression - Short Form: 8-item measure of depression. Scale range 8 to 40. A lower score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated positive affect	Neuro-Quality of Life (QOL) v1.0 Positive affect and well-being - Short form: 9-item measure of positive affect and well-being. Scale range 8 to 48. A higher score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject cognition/processing speed	Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated sleep disturbance	Neuro-QOL v1.0 Sleep disturbance - Short Form: 8-item measure of sleep disturbance. Scale range 8 to 40. A lower score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated pain interference	Patient-Reported Outcomes Measurement Information System (PROMIS) v1.0 Pain Interference - Short Form 6b: 6-item measure of sleep disturbance. Scale range 6 to 30. A lower score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated quality of life	Multiple Sclerosis Impact Scale (MSIS-29): 29-item measure of quality of life. Scale range 29 to 145. A lower score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Change in subject self-rated cognitive function	Neuro-Quality of Life (QOL) v2.0 Cognitive Function - Short Form: 8-item measure of cognitive function. Scale range 8 to 48. A higher score represents a better outcome.	Through study completion, approximately 22 weeks
Secondary	Satisfaction rating of 6-week yoga program on a scale of 1 - 10	Satisfaction scale: Subjects will rate their satisfaction with the yoga program on a scale of 1 - 10. Higher scores indicate a better rating.	At the clinic visit immediately following the yoga/meditation class session