Stretching Exercises Versus Thermotherapy on Restless Legs Syndrome Symptoms

NCT05261035 | Completed DMC

• 1 other identifier: 1206022021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Disorder

Keywords

Muscle Stretching Exercises; Thermotherapy; Restless legs syndrome; Pain; Sleep quality; pregnant women

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Groningen Sleep Quality Scale (GSQS)

  After 7 days

Study Arms (2)

stretching exercises group

EXPERIMENTAL

Pregnant women with RLS were instructed to perform stretching exercises daily for one week

Behavioral: stretching exercises

Thermotherapy group

ACTIVE COMPARATOR

Pregnant women with RLS were instructed to apply warm water immersion of their legs daily for one week.

Other: thermotherapy

Interventions

stretching exercises BEHAVIORAL

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.

stretching exercises group

thermotherapy OTHER

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

Thermotherapy group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Had singleton pregnancy
• During the third-trimester
• Rated restlessness severity greater than ten on the RLS Rating Scale
• Compliant with an iron supplement.

You may not qualify if:

• Had a high-risk pregnancy
• Periodic limb movement disorder
• Leg edema
• Myalgia
• Peripheral neuropathy
• Leg injuries
• Anxiety

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Nursing

Alexandria, 56321, Egypt

Location

Related Publications (4)

• 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.

  PMID: 14592341 BACKGROUND

• 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.

  PMID: 32444058 BACKGROUND

• 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.

  PMID: 29332218 BACKGROUND

• 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.

  PMID: 32284042 BACKGROUND

MeSH Terms

Conditions

Muscular Diseases; Hyperthermia; Restless Legs Syndrome; Pain; Sleep Initiation and Maintenance Disorders

Interventions

Muscle Stretching Exercises; Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: June 5, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 21, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)