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

Not Applicable

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Behavioral: Yoga; Behavioral: Educational film

• Registration Number: NCT03570515
• Lead Sponsor: West Virginia University

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-15
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-27
• Primary Completion: 2019-07-15
• Study Completion: 2021-08-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• ambulatory adults

• at least 21 years of age

• moderate-severe RLS, defined as:

  1. 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));
  2. RLS symptoms at least 1x/wk for the previous 3 months;
  3. a score of at least 2 points (moderate) IRLS question 6: "How severe was your RLS as a whole?"; and
  4. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga	Yoga	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	Educational film	Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home.

Primary Outcome Measures

Name	Time	Method
Retention rates	12 weeks	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)
Adherence rates	12 weeks	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));
Recruitment rate	12 weeks	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.
Participant satisfaction	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Profile of Mood States (POMS)	12 weeks	Mood will be evaluated using the 65-item POMS
Medical Outcomes Study Short Form-36 (SF-36).	12 weeks	Health-related quality of life will be measured using the 36-item SF-36.
Yoga dosing preference	12 weeks	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.
Pittsburgh Sleep Quality Index (PSQI)	12 weeks	Sleep quality will be assessed using the 9-item PSQI
International RLS Rating Scale (IRLS)	12 weeks	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.
Perceived Stress Scale (PSS)	12 weeks	10-item PSS

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States