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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-15

Study Completion Date

2021-08-15

Brief Summary

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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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Detailed Description

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Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Yoga

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Educational film

Intervention Type BEHAVIORAL

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

Interventions

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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, recording their practice on a yoga homework log provided to them.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No