Clinical trial NCT03570515: Yoga vs. Education for Restless Legs Syndrome: a Feasibility Study
Official title: Yoga vs. Education for Restless Legs Syndrome - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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?


Eligibility criteria: 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).

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 weeks
measure: Retention rates
timeFrame: 12 weeks
measure: Adherence rates
timeFrame: 12 weeks
measure: Participant satisfaction
timeFrame: 12 weeks
Secondary outcomes:
measure: Yoga dosing preference
timeFrame: 12 weeks
measure: International RLS Rating Scale (IRLS)
timeFrame: 12 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 weeks
measure: Profile of Mood States (POMS)
timeFrame: 12 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 12 weeks
measure: Medical Outcomes Study Short Form-36 (SF-36).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: WVU
name: Kim E Innes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selfe TK, Montgomery C, Klatt M, Wen S, Sherman KJ, Innes KE. An Exploratory Randomized Controlled Trial of a 12-Week Yoga Versus Educational Film Program for the Management of Restless Legs Syndrome: Feasibility and Acceptability. J Integr Complement Med. 2022 Apr;28(4):309-319. doi: 10.1089/jicm.2021.0182. Epub 2022 Jan 18.
citation: Innes KE, Selfe TK, Montgomery C, Hollingshead N, Huysmans Z, Srinivasan R, Wen S, Hausmann MJ, Sherman K, Klatt M. Effects of a 12-week yoga versus a 12-week educational film intervention on symptoms of restless legs syndrome and related outcomes: an exploratory randomized controlled trial. J Clin Sleep Med. 2020 Jan 15;16(1):107-119. doi: 10.5664/jcsm.8134.
citation: Selfe TK, Wen S, Sherman K, Klatt M, Innes KE. Acceptability and feasibility of a 12-week yoga vs. educational film program for the management of restless legs syndrome (RLS): study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):134. doi: 10.1186/s13063-019-3217-7.