LoveYourBrain Yoga for Multiple Sclerosis

NCT03827928 | Completed

• 1 other identifier: D19058
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Fatigue; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in subject self-rated fatigue

  Through study completion, approximately 22 weeks

• Change in subject self-rated self-efficacy

  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 positive affect

  Through study completion, approximately 22 weeks

Study Arms (2)

Yoga/meditation

EXPERIMENTAL

A 6-week yoga/meditation intervention.

Behavioral: Yoga/meditation

Wait list

NO INTERVENTION

A wait list control period.

Interventions

Yoga/meditation BEHAVIORAL

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.

Yoga/meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 4, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)