Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms (Exersize)
Primary Purpose
Muscle Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
stretching exercises
thermotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Muscle Disorder focused on measuring Muscle Stretching Exercises, Thermotherapy, Restless legs syndrome, Pain, Sleep quality, pregnant women
Eligibility Criteria
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
Sites / Locations
- Faculty of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stretching exercises group
Thermotherapy group
Arm Description
Pregnant women with RLS were instructed to perform stretching exercises daily for one week
Pregnant women with RLS were instructed to apply warm water immersion of their legs daily for one week.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05261035
First Posted
February 18, 2022
Last Updated
February 18, 2022
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT05261035
Brief Title
Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms
Acronym
Exersize
Official Title
Effect of Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms, Pain, and Quality of Sleep Among Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Disorder
Keywords
Muscle Stretching Exercises, Thermotherapy, Restless legs syndrome, Pain, Sleep quality, pregnant women
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stretching exercises group
Arm Type
Experimental
Arm Description
Pregnant women with RLS were instructed to perform stretching exercises daily for one week
Arm Title
Thermotherapy group
Arm Type
Active Comparator
Arm Description
Pregnant women with RLS were instructed to apply warm water immersion of their legs daily for one week.
Intervention Type
Behavioral
Intervention Name(s)
stretching exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
thermotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
RLS Rating Scale
Description
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
Time Frame
After 7 days
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
After 7 days
Secondary Outcome Measure Information:
Title
Groningen Sleep Quality Scale (GSQS)
Description
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.
Time Frame
After 7 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
ZIP/Postal Code
56321
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
14592341
Citation
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.
Results Reference
background
PubMed Identifier
32444058
Citation
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.
Results Reference
background
PubMed Identifier
29332218
Citation
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.
Results Reference
background
PubMed Identifier
32284042
Citation
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.
Results Reference
background
Learn more about this trial
Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms
We'll reach out to this number within 24 hrs