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Completed

NCT Number: NCT03570515

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

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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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 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.

  2. Retention rates

    Time frame: 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)

  3. Adherence rates

    Time frame: 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));

  4. Participant satisfaction

    Time frame: 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 outcomes

  1. Yoga dosing preference

    Time frame: 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.

  2. International RLS Rating Scale (IRLS)

    Time frame: 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.

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 weeks

    Sleep quality will be assessed using the 9-item PSQI

  4. Profile of Mood States (POMS)

    Time frame: 12 weeks

    Mood will be evaluated using the 65-item POMS

  5. Perceived Stress Scale (PSS)

    Time frame: 12 weeks

    10-item PSS

  6. Medical Outcomes Study Short Form-36 (SF-36).

    Time frame: 12 weeks

    Health-related quality of life will be measured using the 36-item SF-36.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Jun 27, 2018
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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