LoveYourBrain Yoga for Multiple Sclerosis
4. februar 2020 opdateret af: Andrew D. Smith III, Dartmouth-Hitchcock Medical Center
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Yoga/meditation
A 6-week yoga/meditation intervention.
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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.
|
|
Ingen indgriben: Wait list
A wait list control period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of conducting a yoga intervention study
Tidsramme: At the clinic visit immediately following the yoga class session
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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.
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At the clinic visit immediately following the yoga class session
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in subject self-rated fatigue
Tidsramme: 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.
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Through study completion, approximately 22 weeks
|
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Change in subject self-rated self-efficacy
Tidsramme: 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.
|
Through study completion, approximately 22 weeks
|
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Change in subject self-rated anxiety
Tidsramme: 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.
|
Through study completion, approximately 22 weeks
|
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Change in subject self-rated depression
Tidsramme: Through study completion, approximately 22 weeks
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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
|
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Change in subject self-rated positive affect
Tidsramme: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Change in subject cognition/processing speed
Tidsramme: Through study completion, approximately 22 weeks
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Single Digit Modalities Test: Measure of cognition/processing speed.
Score range 0 to 110.
A higher score represents a better outcome.
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Through study completion, approximately 22 weeks
|
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Change in subject self-rated sleep disturbance
Tidsramme: Through study completion, approximately 22 weeks
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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
|
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Change in subject self-rated pain interference
Tidsramme: 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.
|
Through study completion, approximately 22 weeks
|
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Change in subject self-rated quality of life
Tidsramme: 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.
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Through study completion, approximately 22 weeks
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Change in subject self-rated cognitive function
Tidsramme: Through study completion, approximately 22 weeks
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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.
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Through study completion, approximately 22 weeks
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Satisfaction rating of 6-week yoga program on a scale of 1 - 10
Tidsramme: At the clinic visit immediately following the yoga/meditation class session
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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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At the clinic visit immediately following the yoga/meditation class session
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2019
Primær færdiggørelse (Faktiske)
30. december 2019
Studieafslutning (Faktiske)
30. december 2019
Datoer for studieregistrering
Først indsendt
23. januar 2019
Først indsendt, der opfyldte QC-kriterier
30. januar 2019
Først opslået (Faktiske)
4. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D19058
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