search
Back to results

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

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Educational film
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Restless Legs Syndrome

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga

Educational Film

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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)
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));
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

Secondary Outcome Measures

Yoga dosing preference
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.
International RLS Rating Scale (IRLS)
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.
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the 9-item PSQI
Profile of Mood States (POMS)
Mood will be evaluated using the 65-item POMS
Perceived Stress Scale (PSS)
10-item PSS
Medical Outcomes Study Short Form-36 (SF-36).
Health-related quality of life will be measured using the 36-item SF-36.

Full Information

First Posted
February 1, 2017
Last Updated
July 7, 2023
Sponsor
West Virginia University
search

1. Study Identification

Unique Protocol Identification Number
NCT03570515
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2015 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
August 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Film
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Yoga
Intervention Description
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
Intervention Name(s)
Educational film
Intervention Description
Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
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.
Time Frame
12 weeks
Title
Retention rates
Description
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)
Time Frame
12 weeks
Title
Adherence rates
Description
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));
Time Frame
12 weeks
Title
Participant satisfaction
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Yoga dosing preference
Description
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.
Time Frame
12 weeks
Title
International RLS Rating Scale (IRLS)
Description
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.
Time Frame
12 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality will be assessed using the 9-item PSQI
Time Frame
12 weeks
Title
Profile of Mood States (POMS)
Description
Mood will be evaluated using the 65-item POMS
Time Frame
12 weeks
Title
Perceived Stress Scale (PSS)
Description
10-item PSS
Time Frame
12 weeks
Title
Medical Outcomes Study Short Form-36 (SF-36).
Description
Health-related quality of life will be measured using the 36-item SF-36.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim E Innes, PhD
Organizational Affiliation
WVU
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35426733
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.
Results Reference
derived
PubMed Identifier
31957638
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.
Results Reference
derived
PubMed Identifier
30770767
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs