Exercise and Restless Legs Syndrome: A Randomized Controlled Trial

Melissa McManama Aukerman, MS; Douglas Aukerman, MD; Max Bayard, MD; Fred Tudiver, MD; Lydia Thorp, MD; Beth Bailey, PhD

Disclosures

J Am Board Fam Med. 2006;19(5):487-493. 

In This Article

Methods

Overview of Study Design

The study was a randomized controlled trial of an exercise program for adults with RLS. The exercise program consisted of 12 weeks of aerobic and resistance exercise performed at a hospital-based wellness center. Outcome measures were assessed at baseline as well as 3, 6, 9, and 12 weeks.

Participants and Recruitment

Participant recruitment was accomplished via television advertisements, notices in local newspapers, and flyers placed in patient areas of an academic medicine primary care clinic. To maximize recruitment, potential participants were prescreened over the telephone before visiting the study site for formal testing. Prescreening eligibility relied on answering yes to the following questions, which are based on the diagnostic criteria for RLS[8]:

  1. Do you have the desire to move the legs in association with unusual or uncomfortable sensations within the legs?

  2. Do you feel the need to move your legs in response to these sensations?

  3. Do these sensations become obvious or worse while at rest (during periods of inactivity or relaxation) and may be temporarily diminished by voluntary movements of the legs?

  4. Do these sensations occur most frequently during the evening or the early part of the night?

Additionally, participants had to be willing to travel to the study site, accept randomization into either an exercise or control group, and confirm that they were not involved in another ongoing research project. Eligible participants from telephone prescreening were brought to the study site for further evaluation by a physician to confirm the diagnosis of RLS, rule out secondary causes, and assure the absence of exclusion criteria.

Participants were excluded from this study for the following reasons: orthopedic condition that limited ambulation on a treadmill or ability to perform prescribed resistance exercises, recent coronary event in the preceding six months, uncontrolled hypertension, renal dysfunction (serum creatinine greater than 1.5 mg/dL) or anemia (hemoglobin <13 g/dL in males and <11 g/dL in females). Information for these exclusion criteria were obtained from the potential participants on-site by the examining physician during the screening physical, which included laboratory analysis of hemoglobin and creatinine. The study physician was then responsible for determining participant suitability for the study. This study was approved by the local institutional review board, and informed consent was obtained in a manner consistent with federal guidelines.

Procedures

Following baseline data collection, qualified participants were placed in a pool and were randomized in waves of 10 using a computer-generated list of random numbers. Participants were randomized, in equal numbers, to either the control group or the exercise group. Both groups were instructed in lifestyle interventions that are thought to improve RLS, including cigarette and alcohol cessation, avoidance of excessive caffeine, and proper sleep hygiene. Both groups returned to the study site at 6 and 12 weeks, at which time they completed assessment tools and were asked about changes in medications or health status. Additionally, participants in both groups were contacted via telephone at 3 and 9 weeks to assess RLS symptom severity.

Measures

Restless leg severity was assessed using the International RLS Study Group (IRLSSG) Scale. This validated 10-item questionnaire was designed to assess symptom severity, frequency, and impact on daily life.[17] Participants completed this questionnaire (assistance was available when needed) at baseline, 6, and 12 weeks, and study personnel blinded to allocation called participants at 3 and 9 weeks to complete the questionnaire over the phone. RLS symptom severity score was determined by summing the questionnaire answers. The maximum score is 40, and a higher score indicates more severe RLS. The total score on the RLS Rating Scale questionnaire was used as the primary outcome measure of RLS severity. Participants also rated overall RLS severity on a scale of 1 to 8, with 1 representing mild symptoms and 8 representing severe symptoms.

Participant physical activity levels were assessed using the CHAMPS physical activity questionnaire for older adults.[18] This questionnaire has been shown to be reliable and valid in the older adult population.[19] The CHAMPS is formatted to assess physical activity in a typical week over the last 4 weeks.

Exercise Intervention Design

The exercise intervention consisted of lower body resistance exercises performed 3 times a week for 12 weeks and treadmill walking for aerobic exercise. The intervention was conducted at a local hospital-based community wellness center with standard exercise equipment and facilities. Following randomization into the exercise intervention group, participants underwent exercise program orientation, which was conducted individually with a certified exercise physiologist. At this visit, participants were first instructed in the use of the treadmill, which included heart rate assessment capability. Walking intensity and duration prescriptions were made in accordance with recommendations of the American College of Sports Medicine current at the time of the study.[20] Participants were instructed to walk for 30 minutes, including a 5 minute warm-up and cool-down, at 40% to 60% of their age-predicted maximum heart rate. Participants were also instructed in the use of the Borg rating of perceived exertion (RPE) scale,[21] and were instructed to maintain exercise intensity that elicited an RPE of 10 to 13.[20]

During this orientation, muscular strength was assessed using a standardized 10-repetition maximum approach, from which one repetition maximum (1-RM) was estimated. The exercise prescription for strength training was made at approximately 50% of the estimated 1-RM. Most of the study participants had never engaged in resistance training; therefore, a low intensity starting point was established for 3 reasons: 1) to familiarize participants with the proper lifting technique, 2) to reduce risk of discomfort and injury, and 3) increase participant adherence to the exercise intervention. Participants were instructed to perform one set of 8 to 12 repetitions of each exercise for the first 2 weeks to provide an introductory period. Following this 2-week period, participants were asked to increase their training to 2 sets of 8 to 12 repetitions of each exercise for the remainder of the exercise intervention. Exercise progression was achieved by instructing participants to increase the weight lifted in a specific exercise when they could perform 2 sets of 12 repetitions without maximal exertion on 2 consecutive training days. The strength training activities included horizontal leg press, leg extension, leg curl, hip adduction, hip abduction, and seated rotary calf press.

The exercise program was completed on an individual basis (eg, not group format), and the participants were free to visit the wellness center anytime during normal operating hours (5:30 AM until 10:00 PM). Participant adherence to the exercise intervention was assessed using an exercise log, which the participants completed for each exercise session. The log was checked daily by a study staff member. Participants were given written and oral feedback on their progress.

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