Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms
NCT ID: NCT05261035
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2021-06-05
2021-11-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Stretching Exercises Versus Aerobic Exercises on Preeclampsia
NCT07255677
Effect of Adding Pelvic Floor Exercises to the Stabilization Exercises in Treating Low Back Pain During Pregnancy
NCT06120959
Effect of Pilates Exercise Versus Circuit Exercise Training on Gestational Hypertension
NCT06618521
Pulsed Electromagnetic Field Versus Active Stretching Exercises on Primary Dysmenorrhoea Randomized Controlled Study
NCT06984003
Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women
NCT06271798
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
stretching exercises group
Pregnant women with RLS were instructed to perform stretching exercises daily for one week
stretching exercises
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.
Thermotherapy group
Pregnant women with RLS were instructed to apply warm water immersion of their legs daily for one week.
thermotherapy
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
stretching exercises
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.
thermotherapy
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* During the third-trimester
* Rated restlessness severity greater than ten on the RLS Rating Scale
* Compliant with an iron supplement.
Exclusion Criteria
* Periodic limb movement disorder
* Leg edema
* Myalgia
* Peripheral neuropathy
* Leg injuries
* Anxiety
18 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alexandria University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zohour Ibrahim Mahmoud Rashwan
Lecturer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Nursing
Alexandria, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1206022021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.