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

CompletedNot a drug-phase studyMS (type not specified)NCT03827928

What it found

No results found

We found no results in the registry or in papers.

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Yoga/meditation

What it measured

Main measures

  • Feasibility of conducting a yoga intervention study

    At the clinic visit immediately following the yoga class session

    Feasibility

Other measures (11)

  • Change in subject self-rated fatigue

    Through study completion, approximately 22 weeks

    FatigueQuality of life (reported by participants)
  • 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

    Mood and sleepQuality of life (reported by participants)
  • Change in subject self-rated depression

    Through study completion, approximately 22 weeks

    Mood and sleepQuality of life (reported by participants)
  • Change in subject self-rated positive affect

    Through study completion, approximately 22 weeks

    Quality of life (reported by participants)
  • Change in subject cognition/processing speed

    Through study completion, approximately 22 weeks

    Thinking and memory
  • Change in subject self-rated sleep disturbance

    Through study completion, approximately 22 weeks

    Mood and sleepQuality of life (reported by participants)
  • Change in subject self-rated pain interference

    Through study completion, approximately 22 weeks

    PainMood and sleepQuality of life (reported by participants)
  • Change in subject self-rated quality of life

    Through study completion, approximately 22 weeks

    Quality of life (reported by participants)
  • Change in subject self-rated cognitive function

    Through study completion, approximately 22 weeks

    Thinking and memoryQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jul 2019

    2. Main results due

      Dec 2019

    3. Finished

      Dec 2019

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