Restless Legs SyndromeNCT03570515
Yoga vs. Education for Restless Legs Syndrome: a Feasibility Study
A study testing Yoga and Educational film in people with Restless Legs Syndrome, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Yoga and Educational film
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2015to 15 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: 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?
- Conditions
- Restless Legs Syndrome
- Being tested
- Yoga, Educational film
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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.
Educational filmBehavioural
Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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));
Measured: 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
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the 9-item PSQI
Measured: 12 weeks
Profile of Mood States (POMS)
Mood will be evaluated using the 65-item POMS
Measured: 12 weeks
Perceived Stress Scale (PSS)
10-item PSS
Measured: 12 weeks
Medical Outcomes Study Short Form-36 (SF-36).
Health-related quality of life will be measured using the 36-item SF-36.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start15 Feb 2015
- Primary completion15 Jul 2019
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim E Innes, PhD, Principal investigator, WVU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570515
- Sponsor's protocol ID
- 1505699758
- Status last verified
- Jul 2023
- First submitted
- 1 Feb 2017
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35426733Innes 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.
PubMed 31957638Selfe 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.
PubMed 30770767
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga vs. Education for Restless Legs Syndrome - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03570515
- Acronym / sponsor ID
- 1505699758
- Conditions
- Restless Legs Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 15 Feb 2015 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaYoga 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 | Active comparator | Behavioral: Educational filmEducational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ambulatory adults
- at least 21 years of age
- moderate-severe RLS, defined as:
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga 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. | Behavioural | Yoga |
| Educational filmEducational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home. | Behavioural | Educational Film |
Primary outcome
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.
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)
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));
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
6 secondary outcomes
Yoga dosing preference
Time frame: 12 weeks
International RLS Rating Scale (IRLS)
Time frame: 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
Profile of Mood States (POMS)
Time frame: 12 weeks
Perceived Stress Scale (PSS)
Time frame: 12 weeks
Medical Outcomes Study Short Form-36 (SF-36).
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 35426733Selfe 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.
- Derived from this study: PubMed 31957638Innes 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.
- Derived from this study: PubMed 30770767Selfe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim E Innes, PhD principal investigator
WVU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Educational film in people with Restless Legs Syndrome, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570515, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.