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LoveYourBrain Yoga for Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03827928
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew D. Smith III, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Yoga/meditation Not Applicable

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 quesitonnaires 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga/meditation
A 6-week yoga/meditation 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.

No Intervention: Wait list
A wait list control period.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in subject self-rated fatigue [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  2. Change in subject self-rated self-efficacy [ Time Frame: Through study completion, approximately 22 weeks ]
    Liverpool Self-efficacy scale: 17-item measure of self-efficacy. Scale range 17 to 68. A higher score represents a better outcome.

  3. Change in subject self-rated anxiety [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  4. Change in subject self-rated depression [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  5. Change in subject self-rated positive affect [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  6. Change in subject cognition/processing speed [ Time Frame: Through study completion, approximately 22 weeks ]
    Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.

  7. Change in subject self-rated sleep disturbance [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  8. Change in subject self-rated pain interference [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  9. Change in subject self-rated quality of life [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  10. Change in subject self-rated cognitive function [ Time Frame: Through study completion, approximately 22 weeks ]
    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.

  11. Satisfaction rating of 6-week yoga program on a scale of 1 - 10 [ Time Frame: At the clinic visit immediately following the yoga/meditation class session ]
    Satisfaction scale: Subjects will rate their satisfaction with the yoga program on a scale of 1 - 10. Higher scores indicate a better rating.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827928


Contacts
Contact: Charlotte Jeffreys, MLS 603-650-3834 charlotte.a.jeffreys@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center

Responsible Party: Andrew D. Smith III, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03827928     History of Changes
Other Study ID Numbers: D19058
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrew D. Smith III, Dartmouth-Hitchcock Medical Center:
Multiple Sclerosis
Fatigue
Anxiety
Depression

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases