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



Status:Recruiting
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:21 - Any
Updated:6/29/2018
Start Date:February 15, 2015
End Date:August 15, 2019
Contact:Kim E Innes, PhD
Email:kinnes@hsc.wvu.edu
Phone:304 293-5206

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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?


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).
We found this trial at
1
site
Morgantown, West Virginia 26506
(304) 293-0111
Phone: 304-293-5206
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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from
Morgantown, WV
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