Clinical trial NCT05261035: Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms
Official title: Effect of Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms, Pain, and Quality of Sleep Among Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Disorder
Keywords: Muscle Stretching Exercises
Thermotherapy
Restless legs syndrome
Pain
Sleep quality
pregnant women
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: RLS Rating Scale
timeFrame: After 7 days
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: After 7 days
Secondary outcomes:
measure: Groningen Sleep Quality Scale (GSQS)
timeFrame: After 7 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
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.
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.
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.
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.