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

NCT03570515 | Completed

• 1 other identifier: 1505699758
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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?

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  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.

  12 weeks

• Retention rates

  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)

  12 weeks

• Adherence rates

  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));

  12 weeks

• Participant satisfaction

  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

  12 weeks

Secondary Outcomes (6)

• Yoga dosing preference

  12 weeks

• International RLS Rating Scale (IRLS)

  12 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  12 weeks

• Profile of Mood States (POMS)

  12 weeks

• Perceived Stress Scale (PSS)

  12 weeks

Study Arms (2)

Yoga

EXPERIMENTAL

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.

Behavioral: Yoga

Educational Film

ACTIVE COMPARATOR

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

Behavioral: Educational film

Interventions

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.

Yoga

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.

Educational Film

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (3)

• 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.

  PMID: 35426733 DERIVED

• 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.

  PMID: 31957638 DERIVED

• 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.

  PMID: 30770767 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Yoga

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Kim E Innes, PhD

  WVU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: June 27, 2018
• Study Start: February 15, 2015
• Primary Completion: July 15, 2019
• Study Completion: August 15, 2021
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)