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

West Virginia University

Status: Completed

Conditions: Restless Legs Syndrome

Treatments: Behavioral: Yoga; Behavioral: Educational film

Study type: Interventional

Funder types: Other

Identifiers

NCT03570515

1505699758

Details and patient eligibility

About

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?

Enrollment: 41 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Yoga

Experimental group

Description:

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.

Treatment:

Behavioral: Yoga

Educational Film

Active Comparator group

Description:

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

Treatment:

Behavioral: Educational film