Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms

Study Overview
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Brief Summary
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To compare the effects of stretching exercises versus thermotherapy on RLS symptoms and sleep quality among pregnant women. Research hypotheses: Pregnant women who perform leg stretching exercises exhibit lower RLS symptoms severity and pain level than those who applied thermotherapy. Pregnant women who perform leg stretching exercises exhibit higher sleep quality than those who applied thermotherapy.

Detailed Description
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a quasi-experimental study was carried out at the antenatal outpatient clinic of XXXX. A sample of 60 pregnant women was randomly assigned to two groups. One group was instructed to perform stretching exercises daily for one week, and the other group applied thermotherapy. They rated their RLS symptoms, pain level, and sleep quality at baseline and after receiving interventions. A convenience sampling of 60 pregnant women who fulfilled the following inclusion criteria was recruited: suffering from RLS according to the IRLSSG criteria during the third-trimester of a singleton pregnancy; rated restlessness severity greater than ten on the RLS Rating Scale, and compliant with an iron supplement. While, women who had a high-risk pregnancy, e.g., preeclampsia, diabetes, and placenta previa as well as had leg cramps, periodic limb movement disorder, leg edema, myalgia, peripheral neuropathy, leg injuries, and anxiety were excluded from the study. Initially, the researchers approached the pregnant women of both groups in the waiting area of the antenatal clinic, established rapport, and collected the socio-demographic data and current pregnancy profile, Moreover, baseline RLS symptoms severity, pain, and women's sleep quality were assessed. Interventions For the stretching exercises group; the researchers explained to the women how to perform the stretching exercises through different visual materials like videos & pictures, provided a demonstration of each step, and emphasized that they could perform this exercise at any comfortable position, standing, sitting, or dorsal. For the thermotherapy group, women were instructed to warm the water to 43-47 C° using a water thermometer or test it with the inner aspect of their wrists. They are also advised to avoid using too hot or too cold water. Then immerse their legs for 20 minutes in the warm water at a height where the water level can reach their knees. The researchers emphasized that the procedure should be done every night for one week. For both groups, the intensity of RLS and pain severity of pregnant women of the two groups were reassessed after the first session.

Official Title
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Effect of Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms, Pain, and Quality of Sleep Among Pregnant Women

Conditions
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Muscle Disorder

Intervention / Treatment
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* Behavioral: stretching exercises
* Other: thermotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Had singleton pregnancy During the third-trimester Rated restlessness severity greater than ten on the RLS Rating Scale Compliant with an iron supplement. Exclusion Criteria: Had a high-risk pregnancy Periodic limb movement disorder Leg edema Myalgia Peripheral neuropathy Leg injuries Anxiety

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stretching exercises group<br>Pregnant women with RLS were instructed to perform stretching exercises daily for one week | Behavioral: stretching exercises<br>* For the stretching exercises group; the researchers explained to the women how to perform the stretching exercises through different visual materials like videos & pictures, provided a demonstration of each step, and emphasized that they could perform this exercise at any comfortable position, standing, sitting, or dorsal.<br>|
| Active Comparator: Thermotherapy group<br>Pregnant women with RLS were instructed to apply warm water immersion of their legs daily for one week. | Other: thermotherapy<br>* women were instructed to warm the water to 43-47 C° using a water thermometer or test it with the inner aspect of their wrists. They are also advised to avoid using too hot or too cold water. Then immerse their legs for 20 minutes in the warm water at a h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RLS Rating Scale | This tool was adopted from the International RLS Study Group. The scale was designed to grade the severity of RLS symptoms. It is composed of ten items rated on a four-point Likert scale ranging from mild (1) to very severe (4). The total scores ranged from 10-to 40. The severity of women's restless leg symptoms was categorized as follows; very severe symptoms (scores 31- 40), Severe (scores 21- 30), Moderate (scores 11-20), Mild (scores 1-10). Abetz, et al. tested RLS Rating Scale for validity and reliability. The concurrent validity was r = 0.70, and internal consistency, alpha=0.81.16 | After 7 days | 
| Numeric Pain Rating Scale (NPRS) | This tool was adopted from the Clinical Manual for Nursing Practice.17 It is a unidimensional measure of pain severity in adult individuals; the 11-point numeric scale varies from 0 (no pain) to 10 (severe pain). It was used to assess four levels of pain: 0 = no pain, 1-3= mild pain, 4-6 = moderate pain, 7-10 = severe pain. | After 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Groningen Sleep Quality Scale (GSQS) | This scale is used to assess the subjects' sleeping patterns and overall sleep quality. It consists of 15-items that scored as true or false. One point was given for all the true items except items 8, 10, and 12 had reversed scores. The scoring system of this scale is as follows; the first question is not counted toward the total score therefore, scores ranged from 0 to 14. According to the total scores, the sleep quality was categorized into three categories; normal refreshing sleep score 0-2, slightly disturbed sleep scores 3-9, and poor quality of sleep scores 10-14. In a validation study, the mean score on the scale was 6.0 ± 4.2 and Cronbach's alpha for internal consistency was 0.88. | After 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle Stretching Exercises, Thermotherapy, Restless legs syndrome, Pain, Sleep quality, pregnant women