- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05261035
Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms (Exersize)
Effect of Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms, Pain, and Quality of Sleep Among Pregnant Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alexandria, Egypt, 56321
- Faculty of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: stretching exercises group
Pregnant women with RLS were instructed to perform stretching exercises daily for one week
|
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.
|
Active Comparator: Thermotherapy group
Pregnant women with RLS were instructed to apply warm water immersion of their legs daily for one week.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RLS Rating Scale
Time Frame: After 7 days
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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
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After 7 days
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Numeric Pain Rating Scale (NPRS)
Time Frame: After 7 days
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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.
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After 7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Groningen Sleep Quality Scale (GSQS)
Time Frame: After 7 days
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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.
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After 7 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003 Mar;4(2):101-19. doi: 10.1016/s1389-9457(03)00010-8.
- Jafarimanesh H, Vakilian K, Mobasseri S. Thermo-therapy and cryotherapy to decrease the symptoms of restless leg syndrome during the pregnancy: A randomized clinical trial. Complement Ther Med. 2020 May;50:102409. doi: 10.1016/j.ctim.2020.102409. Epub 2020 Apr 19.
- Sonmez A, Aksoy Derya Y. Effects of sleep hygiene training given to pregnant women with restless leg syndrome on their sleep quality. Sleep Breath. 2018 May;22(2):527-535. doi: 10.1007/s11325-018-1619-5. Epub 2018 Jan 13.
- Darvishi N, Daneshkhah A, Khaledi-Paveh B, Vaisi-Raygani A, Mohammadi M, Salari N, Darvishi F, Abdi A, Jalali R. The prevalence of Restless Legs Syndrome/Willis-ekbom disease (RLS/WED) in the third trimester of pregnancy: a systematic review. BMC Neurol. 2020 Apr 13;20(1):132. doi: 10.1186/s12883-020-01709-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Psychomotor Agitation
- Restless Legs Syndrome
- Muscular Diseases
Other Study ID Numbers
- 1206022021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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