An interventional study of Yoga and Educational film in Restless Legs Syndrome, sponsored by West Virginia University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by West Virginia University · Not applicable, Interventional, and Other
The purpose of this study is to see whether adults with Restless Legs Syndrome (RLS) are willing to be in a 12-week study where they have a 50-50 chance of being placed in either a gentle yoga program or a film-based education program designed for people with RLS. If so, do they complete the program, and does their RLS, sleep, mood, or quality of life improve?
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 41 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
moderate-severe RLS, defined as:
Exclusion Criteria:
Yoga group participants will attend two, 75-minute yoga classes/week for 4 weeks, then one class/week for 8 weeks, and do a 30-minute home practice on non-class days.
Behavioral: Yoga
Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home.
Behavioral: Educational film
Yoga group participants will attend two, 75-minute yoga classes/week for 4 weeks, then one class/week for 8 weeks, and do a 30-minute home practice on non-class days, recording their practice on a yoga homework log provided to them.
Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home.
Recruitment rate
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on: rates of recruitment and success of different recruitment strategies, and reasons for refusal to participate.
Time frame: 12 weeks
Retention rates
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on: rates of retention (completion of assessment visits)
Time frame: 12 weeks
Adherence rates
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on rates of adherence (completion of home logs and class attendance rates (yoga and film groups); completion of home practice (yoga group));
Time frame: 12 weeks
Participant satisfaction
To determine feasibility and acceptability of the programs, we will collect comprehensive information, both overall and by treatment group, on participant satisfaction, assessed via a structured program evaluation questionnaire regarding participant perceptions of and experiences with the study, and satisfaction regarding their respective programs
Time frame: 12 weeks
Yoga dosing preference
A structured questionnaire regarding possible yoga dosing scenarios will be administered at week 12 to determine participant preferences relative to yoga programs of varying duration and intensity (8 weeks, 16 classes (2x/week); 12 weeks, 16 classes (2x/week for the first 4 weeks, once/week thereafter); 16 weeks, 16 classes (once/week), as well as time of year the classes meet. Information from this questionnaire will aid in optimizing the yoga protocol for our future studies.
Time frame: 12 weeks
International RLS Rating Scale (IRLS)
To determine effect sizes of the programs, data critical to the design of the planned larger randomized clinical trial. RLS symptom severity, the primary efficacy outcome for the full scale trial, will be evaluated using the IRLS, a 10 item scale which includes questions related to frequency, intensity, and impact.
Time frame: 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the 9-item PSQI
Time frame: 12 weeks
Profile of Mood States (POMS)
Mood will be evaluated using the 65-item POMS
Time frame: 12 weeks
Perceived Stress Scale (PSS)
10-item PSS
Time frame: 12 weeks
Medical Outcomes Study Short Form-36 (SF-36).
Health-related quality of life will be measured using the 36-item SF-36.
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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West Virginia University