Effects of Different Exercise Programs on Symptoms, Sleep, and Quality of Life in Patients with Primary Restless Legs Syndrome

ABSTRACT

Background

Restless legs syndrome (RLS) is a sensorimotor disorder that can have a significant detrimental impact on the quality of life and sleep.

Objectives

Our aim was to examine the effects of aerobic exercise and stretching exercise programs on symptom severity, sleep, and quality of life in patients with primary RLS.

Methods

A total of 18 patients between the ages of 22 and 61 were randomly divided into 3 groups as aerobic exercise, stretching exercises, and control. All exercise programs were applied 3 times a week for 8 weeks. Evaluations were performed before and after treatment. Symptom severity of the patients was evaluated by the International Restless Legs Syndrome Study Group Rating Scale, sleep was evaluated with the Pittsburgh Sleep Quality Index and actigraphy, and quality of life was evaluated with the John Hopkins Restless Legs Syndrome Quality of Life Questionnaire. Recovery status of the patients was determined using the post treatment global change scale.

Results

Aerobic exercise and the stretching exercise program were found to be effective in decreasing RLS symptoms (P = 0.025, P = 0.034) and improving subjective sleep quality (P = 0.034, P = 0.025), overall sleep quality (P < 0.001, P = 0.034), and quality of life (P = 0.009, P = 0016). Aerobic exercises were found to be more effective in reducing wake after sleep onset of sleep (P = 0.048), whereas stretching exercises reduced sleep disorders (P = 0.025).

Conclusion

Both exercise approaches have been identified as highly effective approaches in patients with RLS. The treatment can be planned according to the choice of the available facilities, patient and clinician preference, and the advantages of the 2 exercise approaches.

Restless legs syndrome (RLS), also known as Willis‐Ekbom disease, is a common neurological disorder characterized by an uncontrollable need to move the legs. This impulse is often accompanied by uncomfortable or unpleasant sensations in the legs. Symptoms intensify during rest and inactivity, improve with movement, and worsen in the evening and at night. ¹ It occurs both as a primary disease and as a secondary disease related to iron deficiency anemia, pregnancy, or end‐stage renal disease. The syndrome can begin in childhood as well as after the age of 80. Despite its high prevalence, RLS is poorly understood and undertreated in the general community. ²

The wide variety of effects of RLS has a major impact on a patient's life. The use of pharmaceutical therapies can have significant adverse effects. The risk of augmentation is extremely high in dopamine agonists, which are the most often used drugs, and patients may develop impulsive control disorder. Daytime sleepiness, dizziness, and loss of balance have been reported with alpha 2 delta ligands, which are currently recommended over dopamine agonists. Therefore, non‐pharmacological therapies such as exercise can be an effective and alternative approach with minimal adverse effects and a wide range of benefits. ³

Exercise in patients with sleep‐related movement disorders focuses on reducing the severity of their symptoms. It improves sleep quality, sleep efficiency, and percentage of rapid eye movement sleep and reduces wake after sleep onset (WASO) and sleep latency. ⁴ Furthermore, it has the neurobiological effect of improving mental health. ⁵ A variety of disorders have been identified to be associated with RLS. It was reported in a study of patients with multiple sclerosis and RLS that those who lead a more sedentary lifestyle have higher levels of RLS symptoms. ⁶ It has also been determined that physical activity increases functional capacity and reduces physical limitation and pain in patients with RLS who also have diabetes. ⁷

Given the significance of non‐pharmacological treatments, several studies have shown that exercise is an invasive, affordable, and universally accessible form of therapy for patients with RLS. ⁸ , ⁹ However, the majority of these studies were conducted on patients with RLS on dialysis. According to the meta‐analysis about the effectiveness of different exercise programs in patients with RLS on hemodialysis, exercise reduces symptoms, depression, and fatigue. ¹⁰ It was also reported that there was insufficient data about sleep quality and stated the necessity of studies focusing on different exercise types, durations, and intensities to construct the optimal exercise approach for symptom management in patients with RLS. There are a limited number of studies conducted in patients with primary RLS. In the study of Aukerman and colleagues, it was determined that the combined program of aerobic and resistance exercises reduced the severity of symptoms in patients with idiopathic RLS. ¹¹ Thus, there is a need for studies of the effectiveness of exercise in patients with RLS. In addition, to the best of our knowledge, there is no study comparing exercise types. Therefore, the aim of this study is to examine the effect of different exercise programs on symptom severity, sleep, quality of life (QoL) in patients with primary RLS.

Patients and Methods

Study Design

This study was designed as a prospective, randomized controlled trial. It was conducted in accordance with the principles of the Declaration of Helsinki.

Participants

Patients diagnosed with RLS who applied to the Department of Movement Disorders of the Health Sciences University Gulhane Training and Research Hospital, Neurology Outpatient Clinic between September 2021 and June 2022 were included in the study. The inclusion criteria were as follows: a diagnosis of RLS, ¹ age older than 18, never received treatment related to RLS before or discontinued treatment, or persistent symptoms despite the current treatment. The exclusion criteria were musculoskeletal disorder that prevented physical activity, history of ischemic heart disease (recent myocardial infarction or unstable angina, uncontrolled hypertension), liver or kidney dysfunction, anemia, any other sleep disorder, pregnancy, use of psychiatric, psychoactive, or antidepression drugs, history of malignancy, and inadequate cognitive function.

We used a statistical power analysis program (G* power) to compute sample size with an effect size of 0.40, a statistical significance of 0.05, and a power of 0.80. The sample size required for our study, which included 3 groups and 2 timed evaluations, was calculated to be 15 in total, with 5 in each group. To take into account the possibility of a dropout rate, 24 participants (8 people in each group) were included. Post power of the study was calculated using the same power analysis program. The effect size was calculated as 2.64 over the posttreatment mean of the International Restless Legs Syndrome Study Group Rating Scale (IRLSSG‐RS), which evaluates the symptom severity score between the groups. The power of the study was determined as 99% for a total of 18 participants, with a significance level of 0.05 and an effect size of 2.64. The flowchart of the study designed according to the Consolidated Standards of Reporting Trials is shown in Figure 1. ¹²

FIG 1.

Flowchart of the study.

Evaluation

All assessments were performed by an evaluator blinded to the grouping. All patients were informed about the study, and written consent was obtained. A semi structured evaluation form was used to record the demographic and clinical characteristics of the patients (Table 1).

TABLE 1.

Demographic and clinical characteristics of groups

Characteristics	Aerobic Exercise, n = 6	Stretching Exercises, n = 6	Control Group, n = 6	P
Age, years, mean ± SD (min–max)	46.00 ± 6.60 (38–53)	41.50 ± 11.62 (22–52)	42.00 ± 15.00 (22–61)	0.766 a
Height, cm, mean ± SD (min–max)	170.83 ± 5.81 (163–177)	167.67 ± 4.27 (163–174)	166.50 ± 7.55 (158–177)	0.455 a
Weight, kg, mean ± SD (min–max)	80.83 ± 11.28 (70–96)	74.33 ± 19.14 (44–104)	81.17 ± 14.70 (59–103)	0.693 a
Sex, n (%)
Female	2 (33.3)	4 (66.7)	4 (66.7)	0.589 b
Male	4 (66.7)	2 (33.3)	2 (33.3)
Family history of RLS, n (%)
Yes	2 (33.3)	1 (16.7)	5 (83.3)	0.110 b
No	4 (66.7)	5 (83.3)	1 (16.7)
Drug use, n (%)
Yes	6 (100.0)	4 (66.7)	2 (33.3)	0.085 b
No	0 (0.0)	2 (33.3)	4 (66.7)
Side of symptoms, n (%)
Right	0 (0.0)	2 (33.3)	1 (16.7)
Left	1 (16.7)	0 (0.0)	3 (50.0)
Both sides	5 (83.3)	4 (66.7)	2 (33.3)
Time duration from diagnosis, months, median (min–max)	18 (2–120)	66 (48–120)	84 (3–204)	0.185 c

Abbreviations: SD, standard deviation; min, minimum; max, maximum; RLS, restless legs syndrome.

^a One‐way analysis of variance.

^b Fisher‐Freeman‐Halton exact test.

^c Kruskal‐Wallis test.

Symptom Severity

The severity of the patients' RLS‐related symptoms was evaluated with the IRLSSG‐RS, which was recommended to be used to determine the efficacy of treatment in RLS ¹³ and has been shown to be reliable and valid. ¹⁴ , ¹⁵ This scale consists of 10 questions. The first question is about general discomfort, the second is about the need to move around, the third about the relief after moving, the fourth about the quality of sleep, the fifth about fatigue and insomnia during the day, the sixth about the severity, the seventh about the weekly frequency, the eighth about the daily duration of the symptoms, the ninth about the effect of the disease on daily activities, and the last item questions the effect of RLS on mood. Each question is scored as 0 (never), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe). The severity of the symptoms is calculated over the total score and grouped as follows: 1 to 10, mild; 11 to 20, moderate; 21 to 30, severe; and 31 to 40, very severe.

Quality of Life

The QoL was evaluated with the Restless Legs Syndrome Quality of Life questionnaire, which has been shown to be reliable and valid. ¹⁶ , ¹⁷ It can evaluate the effects of treatments on the QoL. Items 1 to 5, 7 to 10, and 13 of the scale, which consists of 18 items in total, are scored as the most severe (5) and the least serious (1). The total score is converted over the following formula: ([actual raw score − lowest possible raw score]/possible raw score range) × 100. A higher score indicates a lower QoL.

Sleep

The sleep quality was evaluated with the Pittsburgh Sleep Quality Index (PSQI), which has been shown to be reliable and valid. ¹⁸ , ¹⁹ It is a subjective self‐report outcome that evaluates sleep characteristics and sleep disturbance for a month. It has 7 subcategories on subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of sleeping drugs, and daytime dysfunction. Each subcategory is scored as 0 to 3. The total score range varies between 0 and 21.

Sleep was also evaluated objectively by using motion‐detecting sensors by actigraphy. Patients were asked to sleep with a MotionWatch 8 device (CamNtech, Fenstanton, UK) on their nondominant wrist for 3 nights (2 days during the week, 1 day on the weekend if the patient was working). ²⁰ The patients were informed about the use of the device and were asked to press the button that activates the system when they go to bed and to turn the system off when they get out of bed during the 3 days of wearing the watch. Data were collected as 30‐second epochs and analyzed with the sleep detection algorithm provided by the sleep software (MotionWare Sleep and Circadian Ryhtm analysis, CamNtech 7.28). Total sleep time, sleep efficiency (total sleep time/time in bed), WASO, and sleep latency were determined as the average of the 3 recorded days.

The recovery status of the patients was evaluated using the Global Rating of Change (GRC). ²¹ This scale consists of a 10‐cm straight line that can be scored from −5 to +5. A value of 0 indicates that the recovery status has not changed, −5 indicates that the current situation is extremely poor compared with the past, and +5 indicates that there is complete recovery.

Intervention

Randomization was performed using computer‐assisted randomization software (https://www.graphpad.com/) by an individual who had no affiliation with the participants. Participants through this program were divided into 3 groups as the aerobic exercise group (AE), the stretching exercises group (SE), and the control group (CG). A total of 24 participants, 8 in each group, were assigned to numbers 1 to 24. The data were stored in an opaque envelope.

Aerobic Exercise

The content of the AE program was planned according to the recommendations of the American College of Sports Medicine (ACSM). ²² AE were performed with a treadmill 3 times a week for 8 weeks under the supervision of a physiotherapist (Fig. 2). The exercises were started at moderate intensity and progressed to high intensity according to the patient's performance. The heart rate (HR) reserve (HRR) formula was used to determine exercise intensity; HRR method: targeted HR = [(HR max − HR rest) × desired exercise intensity] + HR rest. Exercises performed between 40% and 59% of the HRR were classified as moderate intensity, whereas those performed between 60% and 89% of the HRR were high intensity. Each exercise program consisted of warm‐up and cool‐down periods, each lasting 5 minutes. The exercise took a total of 40 minutes. To ensure that the exercises are performed at the targeted HR, a device that measures the HR (Geonaute Dual HR belt, Kalenji, Villeneuve‐ D'ascq, France) was placed over the chest in contact with the xiphoid process of the patients. HR was checked during the treatment by establishing a smart phone connection with the belt via Bluetooth.

FIG 2.

Aerobic exercise program.

Stretching Exercises

The exercise program was created according to the evidence‐based recommendations of the ACSM for flexibility exercises. ²² The detailed exercise list ²³ for each session is given in Appendix S1. Stretching exercises were performed 3 times a week for 8 weeks under the supervision of a physiotherapist (Fig. 3). Each exercise program consisted of warm‐up and cool‐down periods, each lasting 5 minutes. Each exercise was performed as 4 repetitions of 15 seconds or 2 repetitions of 30 seconds for a total of 60 seconds. The total exercise program took about 40 to 45 minutes. The rest period between sets was determined as 2 to 3 minutes. Because there were upper extremity symptoms in half of the patients, a specific region was not differentiated for the exercises. ²⁴ Each exercise session consisted of 7 different exercises targeting major muscle and tendon structures.

FIG 3.

Stretching exercise program.

Control Group

Between the initial evaluation and the final evaluation, the patients in this group received no exercise treatment. The patients were placed in the group they preferred following the final assessment.

Statistical Analysis

The statistical analysis was performed by using the IBM SPSS 26 program (IBM Corp., Armonk, NY). Descriptive statistics included frequency distributions for categorical variables and mean, standard deviation, median, and minimum and maximum values for continuous variables. The Shapiro–Wilk test was used to evaluate the normality of data. Fisher's exact test was used to compare categorical data, and 1‐way analysis of variance (ANOVA) and Kruskal–Wallis analysis were used to compare continuous data in terms of demographic characteristics between groups. The effect sizes of the group comparisons were calculated. The effect size was accepted as r = 0.10, small; r = 0.30, medium; r = 0.5, large; and r ≥ 0.70, very large effect. ²⁵ The statistical significance level was set as P < 0.05. All parametric assumptions were met, and therefore appropriate parametric tests were used to determine the differences between and within groups. ANOVA was used in multiple group comparisons followed by the Tukey test. The group–time interaction was added when there was a difference between groups before or after treatment.

Results

The demographic and clinical characteristics of the patients (n = 18) are presented in Table 1. The AE and SE showed a very high within‐group decrease on the symptom severity. There were significant within‐group increases in QoL in the AE and SE, but not in the CG. However, the between‐group differences of symptom severity and QoL were not significant between the AE and SE (Table 2). Both the AE and SE improved in both the total sleep score and subjective sleep quality determined by PSQI. Only the SE showed a significant change within the group in reducing sleep disturbances (Table 3). There was only a slight difference in the reduction of WASO in the AE (Table 4). The GRC was determined as 2/5 for both the AE and SE.

TABLE 2.

Comparison of symptom severity and quality of life within and between groups

Variable	Group	n	Pretreatment Mean ± SD	Posttreatment Mean ± SD	t	P	r (Effect Size)
IRLSSG‐RS	CO	6	20.00 ± 9.25	20.17 ± 8.13	−0.222	0.833	0.099
	AE	6	33.67 ± 5.92	26.50 ± 6.86	3.155	0.025 a	0.816
	SE	6	27.33 ± 3.32	22.17 ± 5.34	2906	0.034 a	0.793
					Group × Time
			F = 6.392	F = 1.330	F = 4.853
			P = 0.010 a	P = 0.294	P = 0.024 a
			CO‐AE b
RLS‐QoL	CO	6	35.42 ± 26.24	35.00 ± 19.81	0.106	0.920	0.047
	AE	6	62.92 ± 22.93	33.75 ± 14.29	4.183	0.009 a	0.882
	SE	6	49.58 ± 18.86	18.33 ± 7.69	3.581	0.016 a	0.848
			F = 2.167	F = 2.364
			P = 0.149	P = 0.128

Abbreviations: SD, standard deviation; IRLSSG‐RS, International Restless Legs Syndrome Study Group Rating Scale; CO, control group; AE, aerobic exercise group; SE, stretching exercise group; RLS‐QoL, Restless Legs Syndrome Quality of Life Questionnaire.

^a P < 0.05.

^b Difference between group.

TABLE 3.

Comparison of self‐reported sleep within and between groups

Variable	Group	n	Pretreatment Mean ± SD	Posttreatment Mean ± SD	t	P	r (Effect Size)
Subjective sleep quality (PSQI)	CO	6	1.33 ± 1.03	1.67 ± 0.81	−1.000	0.363	0.408
	AE	6	2.17 ± 0.98	1.00 ± 0.00	2.907	0.034 a	0.793
	SE	6	1.50 ± 0.83	0.83 ± 0.40	3.162	0.025 a	0.816
					Group × Time
			F = 1.280	F = 1.373	F = 5.526
			P = 0.307	P = 0.036 a	P = 0.016 a
				CO‐SE c
Sleep latency (PSQI)	CO	6	1.00 ± 1.54	1.50 ± 1.37	−1.464	0.203	0.548
	AE	6	1.83 ± 1.16	1.17 ± 0.98	2.000	0.102	0.667
	SE	6	2.17 ± 0.98	1.50 ± 1.04	1.348	0.235	0.516
			F = 1.373	F = 0.168
			P = 0.283	P = 0.847
Sleep duration (PSQI)	CO	6	0.67 ± 0.81	0.83 ± 0.983	−0.542	0.611	0.236
	AE	6	0.83 ± 0.75	0.83 ± 0.753	0.000	1.000	–
	SE	6	1.33 ± 1.21	1.33 ± 1.033	0.000	1.000	–
			F = 0.802	F = 0.577
			P = 0.467	P = 0.574
Sleep efficiency (PSQI)	CO	6	0.17 ± 0.40	0.33 ± 0.51	−1.000	0.363	0.408
	AE	6	1.00 ± 0.63	0.33 ± 0.51	2.000	0.102	0.667
	SE	6	1.17 ± 0.98	0.67 ± 0.81	1.464	0.203	0.548
			F = 3.370	F = 0.556
			P = 0.062	P = 0.585
Sleep disorders (PSQI)	CO	6	2.00 ± 0.63	2.00 ± 0.63	0.000	1.000	–
	AE	6	2.50 ± 0.54	1.83 ± 0.75	0.243	0.102	0.108
	SE	6	2.17 ± 0.75	1.50 ± 0.54	0.728	0.025 a	0.310
			F = 0.921	F = 0.921
			P = 0.419	P = 0.419
Sleep medicine (PSQI)	CO	6	0.00 ± 0.00	0.00 ± 0.00	–	–	–
	AE	6	0.50 ± 1.22	0.00 ± 0.00	1.000	0.363	0.167
	SE	6	0.00 ± 0.00	0.00 ± 0.00	–	–	–
			F = 1.000	‐
			P = 0.391
Daytime dysfunction (PSQI)	CO	6	1.17 ± 0.98	1.17 ± 0.75	−2.907	1.000	0.628
	AE	6	1.83 ± 0.75	1.17 ± 0.98	−5.966	0.102	0.877
	SE	6	1.50 ± 0.83	1.17 ± 0.40	−4.392	0.363	0.794
			F = 0.896	F = 0.000
			P = 0.429	P = 1.000
Total (PSQI)	CO	6	6.33 ± 3.55	7.50 ± 3.72	−1.115	0.315	0.446
	AE	6	10.83 ± 3.43	6.17 ± 2.92	8.367	0.000 b	0.966
	SE	6	9.83 ± 4.07	7.00 ± 2.82	2.890	0.034 a	0.791
			F = 2.451	F = 0.268
			P = 0.120	P = 0.768

Abbreviations: SD, standard deviation; PSQI, Pittsburg Sleep Quality Index; CO, control group; AE, aerobic exercise group; SE, stretching exercise group.

^a P < 0.05;

^b P < 0.001.

^c Difference between group.

TABLE 4.

Comparison of sleep (actigraphy) within and between groups

Variables	Group	n	Pretreatment Mean ± SD	Posttreatment Mean ± SD	t	P	r (Effect Size)
Sleep efficiency (actigraphy)	CO	6	84.65 ± 4.21	83.95 ± 4.46	1.500	0.194	0.557
	AE	6	84.14 ± 5.07	86.56 ± 6.50	−1.896	0.117	0.647
	SE	6	76.30 ± 9.40	81.64 ± 4.54	−1.619	0.166	0.586
			F = 2.986	F = 1.318
			P = 0.081	P = 0.297
Wake after sleep onset (actigraphy)	CO	6	40.62 ± 9.83	52.39 ± 17.11	−2.052	0.095	0.676
	AE	6	49.39 ± 18.43	37.39 ± 7.47	2.607	0.048 a	0.759
	SE	6	88.19 ± 33.73	63.94 ± 18.26	1.961	0.107	0.659
					Group × Time
			F = 7.329	F = 4.677	F = 4.862
			P = 0.006 b	P = 0.026 a	P = 0.024
			1, 2–3 c	2–3 c
Sleep duration (actigraphy)	CO	6	341.00 ± 26.28	348.11 ± 52.75	−0.292	0.782	0.129
	AE	6	309.03 ± 39.72	338.97 ± 48.30	−1.330	0.241	0.511
	SE	6	348.44 ± 41.90	349.61 ± 44.71	−0.077	0.942	0.034
			F = 1.961	F = 0.084
			P = 0.175	P = 0.920
Sleep latency (actigraphy)	CO	6	13.44 ± 12.59	17.56 ± 15.98	−1.150	0.302	0.457
	AE	6	12.39 ± 8.66	8.14 ± 12.30	1.084	0.328	0.436
	SE	6	30.86 ± 27.28	30.17 ± 32.81	0.094	0.929	0.042
			F = 1.981	F = 1.483
			P = 0.172	P = 0.258

Abbreviations: SD, standard deviation; CO, control group; AE, aerobic exercise group; SE, stretching exercise group.

^a P < 0.05;

^b P < 0.01.

^c Difference between group.

Discussion

As a result of our study, which aimed to examine the effects of aerobic exercise and stretching exercises on symptom severity, sleep, and QoL in patients with primary RLS, both exercise programs performed 3 times a week for 8 weeks reduced symptoms and improved QoL and subjective and overall sleep quality. In addition, aerobic exercises were found to be more effective in reducing WASO, whereas stretching exercises reduced sleep disorders. This is the first study to compare different types of exercise in patients with RLS.

Our study found that 3‐times‐a‐week aerobic exercise and stretching exercises programs followed for 8 weeks resulted in 21% and 18% improvements, respectively, in patients with primary RLS. Both aerobic exercise and stretching exercises have shown very large effect sizes in decreasing the severity of symptoms, and they did not differ from each other. In addition, these improvements in groups exceeded the minimal clinically important difference. ²⁶ A number of studies performed in patients with RLS revealed the change in symptom severity with exercise. Studies in patients with RLS on hemodialysis have indicated that 4‐to 6‐month aerobic exercise and stretching exercises lowered the severity of symptoms compared with control or dopamine treatment. ²⁷ , ²⁸ , ²⁹ , ³⁰ , ³¹ , ³² Although there are studies on the effectiveness of aerobic exercise and stretching exercises in patients with primary RLS, there is no comparison between the exercises. ³³ , ³⁴ Exercise has been shown to modulate dopamine and glutamate neurotransmission and synaptogenesis and enhance regional cerebral blood flow. ³⁵ However, there has been little research with animal models for sleep, physical exercise, and movement disorders and the dopaminergic system, making it difficult to comprehend the various pathways involved with symptom alleviation through exercise. ³⁶ Several physiological mechanisms might theoretically explain the ability to alleviate RLS symptoms with exercise. These include increased β‐endorphin release, ⁴ increased cerebral blood flow, ³⁷ positive effects of exercise training on basal ganglia neuroplasticity, ³⁵ and the improvement in antioxidant mechanisms. ³⁸ As a result, exercise has the potential to provide multiple therapeutic benefits that are compatible with the complicated pathophysiology of RLS.

Subjective sleep and total sleep quality improved in both exercise groups, with varying effect sizes. Only the aerobic exercise decreased the WASO, whereas the stretching exercises decreased sleep disturbances. This may be attributed to the fact that stretching exercises may be more effective for relaxing and aerobic exercise produces more autonomous responses. Tworoger et al ³⁹ compared moderate‐intensity aerobic exercise to a stretching exercises program in postmenopausal women. Both treatments demonstrated an improvement in sleep in sedentary, overweight, and postmenopausal women. At the same time, the stretching exercises program may assist women in transitioning to sleep, minimizing their need for sleeping pills. In a study by D'Aurea and colleagues, the effect of resistance exercises and stretching exercises in patients with chronic insomnia was compared. ⁴⁰ Both exercise approaches have similar benefits in sleep quality, both objectively and subjectively. Although the mechanism of exercise improving sleep is not fully known, there are several sleep‐promoting physiological states that exercise affects: (1) regulation of body temperature, (2) cardiac and autonomic functions, (3) hormone and metabolic regulation, (4) immune‐inflammatory response, and (5) mood. ⁴¹ , ⁴² Although both stretching exercises and aerobic exercise have shown to have positive effects on sleep in different populations, our study is the first to compare these exercises in patients with primary RLS.

QoL improved by 46% and 63% in the AE and SE, respectively. This is extremely promising for the population of patients with RLS whose QoL is dramatically affected. The World Health Organization defines health not only as the absence of disease but also as a state of complete (physical, mental, and social) well‐being. ⁴³ RLS has a significant effect on both the physical and mental dimensions of patients' QoL. In fact, people with RLS typically have a lower QoL than those with other prevalent chronic conditions. ⁴⁴ Therefore, it is not effective enough to treat symptoms alone in patients with RLS. A holistic approach is needed that will affect mental and social health components such as fatigue, depression, and QoL. As a result of our study, both exercise types made a significant difference in improving QoL. This significant change in QoL may be because exercise not only treats RLS symptoms but also has an effect on many other dimensions.

Many clinicians question how their patients change after treatment and use this information to guide the treatment process. Therefore, many studies prefer a patient‐rated scale to determine a particular treatment. ²¹ According to our findings, patients in both exercise groups rated themselves as healed on a scale of 2/5, which shows a significant gain in a chronic condition and high patient satisfaction. In addition, the patients in the CG interpreted the process as “never changed.” We did not record any improvement in the CG in any of our evaluations. There was even a deterioration in some parameters. The fact that patients with RLS who are left unsupervised do not improve suggests that these patients have limited access to health professionals who will assist them on a regular basis. As a result of our study, there was no significant difference between the AE and SE aside from the additional benefits that emerged in several assessment parameters. Therefore, the decision‐making process can be shared with a patient by consulting the patient when choosing the appropriate treatment. This approach can create a 2‐way relationship between the patient and the therapist. In this way, patients feel less anxious, more self‐confident, and have less conflict with their therapists by knowing more about their health status, which leads to an improvement in patient satisfaction, compliance, and success of the treatment. ⁴⁵

Although we have reached the sample size that we aimed, it may seem that there are a small number of patients for an exercise study. Most of the exercise studies in patients with RLS were conducted in patients receiving hemodialysis treatment. It is possible to reach ideal numbers in these studies because secondary RLS is extremely common, especially in patients receiving hemodialysis treatment. Between September 2021 and June 2022, we worked in the clinic with the highest number of patients with RLS in the capital city, and as we stated in the flowchart, it was possible to reach only this number of patients with RLS. Only 3 studies investigating exercise with potentially primary RLS can be compared with our study in terms of sample size. Esteves et al included only 11 participants, ⁴ and the Haider et al study included 30 patients with RLS who were obese with no exclusion criteria for anemia or pregnancy. ³⁴ In the study by Aukerman and colleagues, which is a pioneering study in terms of exercise in patients with RSL, secondary conditions were excluded, and the study was completed with only 28 patients. ¹¹

We acknowledge some limitations. A combined model with quantitative and qualitative methods might provide a better evaluation of emotionally, psychologically, and cognitively impacted patients with RLS. In addition, the follow‐up duration was restricted to 8 weeks. Therefore, it is unknown if the effectiveness of exercise programs persists over time. The strength of our study is the originality. This is the first study to compare the effectiveness of different exercise approaches in patients with RLS with a comprehensive focus on sleep and QoL specific to RLS. Future studies may examine the effectiveness of exercises performed at different intensities and plan studies with mixed models in patients with RLS.

Author Roles

(1) Research Project: A. Conception, B. Organization, C. Execution; (2) Statistical Analysis: A. Design, B. Execution, C. Review and Critique; (3) Manuscript: A. Writing of the First Draft, B. Review and Critique.

Ö.Ç.: 1A, 1B, 1C, 2A, 2C, 3A

N.Ü.Y.: 1A, 1B, 1C, 2A, 2C, 3C

M.E.Y.: 1A, 1C, 3C

A.R.S.: 1B, 1C, 2A, 3C

Disclosures

Ethical Compliance Statement: We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. The study was approved by the Gulhane Scientific Research Ethics Committee of the University of Health Sciences (2020–422) and registered at ClinicalTrials.gov (identifier NCT04711993, first received January 15, 2021). All participants gave written informed consent prior to inclusion.

Funding Sources and Conflicts of Interest: The study was supported by the University of Health Sciences, Scientific Research and Projects Unit, PhD Thesis Project (2021–28) and the Scientific and Technological Research Council of Türkiye 2211 Program.

Financial Disclosures for the Previous 12 Months: Nothing to report.

Supporting information

Appendix S1. Details of stretching exercises program.