Multiple SclerosisNCT03827928
LoveYourBrain Yoga for Multiple Sclerosis
A study testing Yoga/meditation in people with Multiple Sclerosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Yoga/meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
- 18 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Yoga/meditation
- Keywords
- Multiple Sclerosis, Fatigue, Anxiety, Depression
- Medical subject headings
- Multiple Sclerosis, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga/meditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga/meditation | Experimental | A 6-week yoga/meditation intervention. Receives: Behavioral: Yoga/meditation |
| Wait list | No intervention | A wait list control period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the clinic visit immediately following the yoga class session
Secondary outcomes (11)
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: Through study completion, approximately 22 weeks
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.
Measured: At the clinic visit immediately following the yoga/meditation class session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew D. Smith III, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827928
- Sponsor's protocol ID
- D19058
- Status last verified
- Feb 2020
- First submitted
- 23 Jan 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03827928
- Acronym / sponsor ID
- D19058
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Fatigue, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga/meditation | Experimental | Behavioral: Yoga/meditationA 6-week yoga/meditation intervention. |
| Wait list | No intervention | –A wait list control period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
- 18 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga/meditationA 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. | Behavioural | Yoga/meditation |
Primary outcome
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.
11 secondary outcomes
Change in subject self-rated fatigue
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated self-efficacy
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated anxiety
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated depression
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated positive affect
Time frame: Through study completion, approximately 22 weeks
Change in subject cognition/processing speed
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated sleep disturbance
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated pain interference
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated quality of life
Time frame: Through study completion, approximately 22 weeks
Change in subject self-rated cognitive function
Time frame: Through study completion, approximately 22 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga/meditation in people with Multiple Sclerosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of conducting a yoga intervention study (time frame: At the clinic visit immediately following the yoga class session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.