Yoga vs. Education for Restless Legs Syndrome: a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
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?

Official Title
-----------------
Yoga vs. Education for Restless Legs Syndrome - a Feasibility Study

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Behavioral: Yoga
* Behavioral: Educational film


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory adults at least 21 years of age moderate-severe RLS, defined as: symptoms that meet all five of the International RLS Study Group essential diagnostic criteria for RLS (i.e., 1) an urge to move the legs, often associated with discomfort or disagreeable sensations in the legs, that 2) begins or worsen during periods of rest or inactivity; 3) is partially or totally relieved by movement; 4) is worse or only occurs in the evening or night; and 5) is not solely accounted for by another condition (e.g. leg cramps, positional discomfort, habitual foot tapping)); RLS symptoms at least 1x/wk for the previous 3 months; a score of at least 2 points (moderate) IRLS question 6: How severe was your RLS as a whole?; and RLS diagnostic criteria applied as per training by the study physician, a sleep medicine expert; these criteria will help ensure exclusion of mimics (e.g. leg cramps, positional discomfort). 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: practiced yoga within the past year; currently on dopaminergic agents (eg, ropinirole, pramipexole) or anti-psychotic medication; changed dosage if any other central nervous system agents (e.g., sedative hypnotics, gamma-aminobutyric acid (GABA) analogs, narcotic analgesics, antiadrenergic agents, or anticonvulsants) within the past 3 months; any orthopedic, neurologic or other condition that might prevent safe completion of a 12-week yoga program or confound assessments (e.g., neuropathy; Parkinson's disease; stroke; rheumatoid arthritis; renal failure; uncontrolled sleep apnea; recent (within the last 6 months) myocardial infarction; heart failure; cancer (other than non-melanoma skin cancer); pregnant or within 6 months post-partum).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>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<br>* 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.<br>|
| Active Comparator: Educational Film<br>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<br>* Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |