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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga | Experimental | 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. |
|
| Educational Film | Active Comparator | Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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)); | 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
ambulatory adults
at least 21 years of age
moderate-severe RLS, defined as:
willingness and ability to complete the 12-week yoga or educational film program and all study assessments;
willingness to avoid use of any new drugs or treatments other than the assigned intervention.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim E Innes, PhD | WVU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35426733 | Derived | Selfe TK, Montgomery C, Klatt M, Wen S, Sherman KJ, Innes KE. An Exploratory Randomized Controlled Trial of a 12-Week Yoga Versus Educational Film Program for the Management of Restless Legs Syndrome: Feasibility and Acceptability. J Integr Complement Med. 2022 Apr;28(4):309-319. doi: 10.1089/jicm.2021.0182. Epub 2022 Jan 18. | |
| 31957638 |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Educational film | Behavioral | Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home. |
|
| 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. | 12 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | Sleep quality will be assessed using the 9-item PSQI | 12 weeks |
| Profile of Mood States (POMS) | Mood will be evaluated using the 65-item POMS | 12 weeks |
| Perceived Stress Scale (PSS) | 10-item PSS | 12 weeks |
| Medical Outcomes Study Short Form-36 (SF-36). | Health-related quality of life will be measured using the 36-item SF-36. | 12 weeks |
| Innes KE, Selfe TK, Montgomery C, Hollingshead N, Huysmans Z, Srinivasan R, Wen S, Hausmann MJ, Sherman K, Klatt M. Effects of a 12-week yoga versus a 12-week educational film intervention on symptoms of restless legs syndrome and related outcomes: an exploratory randomized controlled trial. J Clin Sleep Med. 2020 Jan 15;16(1):107-119. doi: 10.5664/jcsm.8134. |
| 30770767 | Derived | Selfe TK, Wen S, Sherman K, Klatt M, Innes KE. Acceptability and feasibility of a 12-week yoga vs. educational film program for the management of restless legs syndrome (RLS): study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):134. doi: 10.1186/s13063-019-3217-7. |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |