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

July 7, 2023 updated by: West Virginia University

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yoga dosing preference
Time Frame: 12 weeks
A structured questionnaire regarding possible yoga dosing scenarios will be administered at week 12 to determine participant preferences relative to yoga programs of varying duration and intensity (8 weeks, 16 classes (2x/week); 12 weeks, 16 classes (2x/week for the first 4 weeks, once/week thereafter); 16 weeks, 16 classes (once/week), as well as time of year the classes meet. Information from this questionnaire will aid in optimizing the yoga protocol for our future studies.
12 weeks
International RLS Rating Scale (IRLS)
Time Frame: 12 weeks
To determine effect sizes of the programs, data critical to the design of the planned larger randomized clinical trial. RLS symptom severity, the primary efficacy outcome for the full scale trial, will be evaluated using the IRLS, a 10 item scale which includes questions related to frequency, intensity, and impact.
12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12 weeks
Sleep quality will be assessed using the 9-item PSQI
12 weeks
Profile of Mood States (POMS)
Time Frame: 12 weeks
Mood will be evaluated using the 65-item POMS
12 weeks
Perceived Stress Scale (PSS)
Time Frame: 12 weeks
10-item PSS
12 weeks
Medical Outcomes Study Short Form-36 (SF-36).
Time Frame: 12 weeks
Health-related quality of life will be measured using the 36-item SF-36.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Investigators

  • Principal Investigator: Kim E Innes, PhD, WVU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2015

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

August 15, 2021

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1505699758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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