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

Terry Kit Selfe, Sijin Wen, Karen Sherman, Maryanna Klatt, Kim E Innes, Terry Kit Selfe, Sijin Wen, Karen Sherman, Maryanna Klatt, Kim E Innes

Abstract

Background: Restless legs syndrome (RLS) is a common and burdensome sleep disorder associated with profound impairment of health, well-being, and quality of life. Unfortunately, the medications used for RLS management carry risk of serious side effects, including augmentation of symptoms. Yoga, an ancient mind-body discipline designed to promote physical, emotional, and mental well-being, may offer a viable, low-risk new treatment. The primary objectives of this pilot, parallel-arm, randomized controlled trial (RCT) are to assess the acceptability and feasibility of a 12-week yoga vs. educational film program for the management of RLS.

Methods: Forty-four adults with confirmed moderate to severe RLS will be recruited and randomized to a 12-week yoga (n = 22) or standardized educational film program (N = 22). Yoga group participants will attend two 75-min Iyengar yoga classes per week for the first 4 weeks, then one 75-min class per week for the remaining 8 weeks, and will complete a 30-min homework routine on non-class days. Educational film group participants will attend one 75-min class per week for 12 weeks and complete a daily RLS treatment log; classes will include information on: RLS management, including sleep hygiene practices; other sleep disorders; and complementary therapies likely to be of interest to those participating in a yoga and sleep education study. Yoga and treatment logs will be collected weekly. Feasibility outcomes will include recruitment, enrollment, and randomization rates, retention, adherence, and program satisfaction. Program evaluation and yoga-dosing questionnaires will be collected at week 12; data on exploratory outcomes (e.g., RLS symptom severity (IRLS), sleep quality (PSQI), mood (POMS, PSS), and health-related quality of life (SF-36)) will be gathered at baseline and week 12.

Discussion: This study will lay the essential groundwork for a planned larger RCT to determine the efficacy of a yoga program for reducing symptoms and associated burden of RLS. If the findings of the current trial and the subsequent larger RCTs are positive, this study will also help support a new approach to clinical treatment of this challenging disorder, help foster improved understanding of RLS etiology, and ultimately contribute to reducing the individual, societal, and economic burden associated with this condition.

Trial registration: ClinicalTrials.gov, ID: NCT03570515 . Retrospectively registered on 1 February 2017.

Keywords: Acceptability; Behavioral intervention; Feasibility; Mind-body therapy; Mood; Quality of life; Restless legs syndrome; Sleep; Yoga.

Conflict of interest statement

Ethics approval and consent to participate

As described above, this study has been approved by the West Virginia University Institutional Review Board (IRB#1505699758) and each participant will provide written informed consent prior to the initiation of baseline assessments or the intervention.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow diagram
Fig. 2
Fig. 2
Schedule of evaluations. *To be monitored continuously throughout study until study is closed to enrollment. Abbreviations: BP blood pressure, BMI Body Mass Index (weight(kg)/height(m)2), CEQ Credibility/Expectancy Questionnaire, HR heart rate, DSSI Duke Social Support Index, IRLS International Restless Legs Scale, PASE Physical Activity Scale for the Elderly, POMS Profile of Mood States, PSQI Pittsburgh Sleep Quality Index, PSS Perceived Stress Scale, SF-36 36-item MOS Short Form-36, Tx treatment

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