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

Results

Study Completion Rates

Approximately 200 adults inquired about participation in the study. Telephone screening determined preliminary eligibility for about half of these, and the first 60 who resided within an easy commuting distance from our facilities were scheduled for an initial appointment. After the elimination of those who did not show up for any of their appointments, as well as those who did not meet inclusion criteria (as detailed above), 43 participants were enrolled in the study. Of the 43, two did not complete the RLS Rating Scale at baseline and were excluded from participation. The remaining 41 participants were randomly assigned to either the exercise or the control group. Due to scheduling constraints, a delay of up to 4 weeks in contacting participants with exercise group assignment occurred. By this time, 13 (9 exercise and 4 controls) were no longer available to participate for various reasons including changes in work schedule, injury, unresolved or worsening medical conditions, and relocation. Thus, the final sample that participated in assigned treatment groups and completed assessments at 6 weeks post assignment was 28: 11 exercise group participants and 17 controls. At 12 weeks, data were available for 11 exercise group assignees and 12 controls.

Initial analyses revealed no significant attrition bias. Those assigned to the exercise group were more likely than control group members to be unavailable for participation on notification of treatment group assignment (45% vs 20%, P < .01). However, those 13 unavailable when contacted did not differ significantly from the 28 available on RLS Rating Scale scores nor on any available demographic variables (P > .05). Additionally, those who participated for the full 12 weeks did not differ from those who participated for only 6 weeks on treatment group assignment, RLS Rating Scale scores, or on any demographic variables (P > .05).

Group Baseline Differences

Baseline demographic and basic physical and medical characteristics of the participants are presented in Table 1 . The average age was 53 years. Although treatment group assignments were random, some differences between the two groups in baseline variables were evident. The exercise group participants were significantly taller than the control group. In addition, although not statistically significant, there was a trend for exercise group participants to be more likely to be male and to be slightly heavier. However, none of these background variables was significantly related to any of the baseline RLS scores. Because of this and small sample size, analyses presented below did not include controlling for any of these factors. Before the study, 2 control group participants were on pramipexole (a dopamine agonist) and 2 exercise group participants were on the anticonvulsant gabapentin. Both of these medications have been shown to improve the symptoms of RLS. During the course of the study, no patients had changes in medications known to improve or exacerbate RLS symptoms. Furthermore, there was no significant difference between the 2 groups in baseline exercise frequency or energy expenditure based on the CHAMPS questionnaire.

Change in RLS Symptoms

A comparison of the exercise and control groups on RLS Rating Scale scores is presented in Table 2 . The exercise and control groups did not differ significantly in either the total RLS severity total score or the 8-point rating at baseline. However, by 6 weeks, the exercise group scored significantly lower on both the total RLS severity score and the rating, indicating improvement of symptoms. Severity scores for the control group decreased less than 8% over 6 weeks, whereas exercise group severity scores dropped by 39% during the same time period. Scores for both groups remained relatively stable from six to twelve weeks, with symptom improvement from baseline only evident for the exercise group. One exercise group participant developed knee pain while participating in the exercise intervention. This required referral to an orthopedic surgeon.

In addition to the analyses presented in Table 2 , factorial repeated measures MANOVAs were calculated to examine change in RLS scores over time by group status. The severity scores of the control group did not change significantly over time. The exercise group changed from baseline to week 6 [F(2,9) = 84.0, P < .001], but did not change significantly from week 6 to week 12. When the 2 groups were examined together, the group by severity score interaction was significant (F = 7.74, P = .010), indicating that the exercise and control groups differed significantly over time. The same pattern was observed for the rating scores. The control group did not change significantly over time. The exercise group changed from baseline to week 6 [F(2,9) = 119, P < .001], but did not change significantly from week 6 to week 12. When the 2 groups were examined together, the group by rating score interaction was significant (F = 10.49, P = .003), indicating that the exercise and control groups differed significantly over time. Analysis was by intention to treat.

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