Comparative Effects of Aerobic and Muscle Relaxation Exercises in Pregnant Women With Restless Leg Syndrome

June 4, 2026 updated by: Riphah International University

Comparative Effects of Aerobic and Muscle Relaxation Exercises to Improve Sleep Quality, Fatigue Level, Pain Intensity and Quality of Life in Pregnant Women With Restless Leg Syndrome

This study will be a randomized controlled trial and will be conducted in the Gynecology and Physiotherapy departments of Valencia Health Clinic, Lahore. Non-probability purposive sampling will be used to collect data. A total of 40 pregnant women aged between 20-35 years, in their 2nd or 3rd trimester and clinically diagnosed with RLS, will be included after fulfilling inclusion and exclusion criteria and giving informed consent. Subjects will be randomly divided into two groups using a random number generator table. Group A will receive supervised aerobic exercises for 8 weeks while Group B will undergo progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks. Both groups will be assessed at baseline and after the 8-week intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Restless Legs Syndrome (RLS) is a neurological disorder that often worsens during pregnancy, particularly in the second and third trimesters. It is characterized by an uncontrollable urge to move the legs, often accompanied by discomfort or pain, and is known to disrupt sleep, increase fatigue, and negatively affect the quality of life. Pharmacological treatments for RLS during pregnancy are limited due to safety concerns, creating a need for effective, non-drug interventions. Aerobic exercise and progressive muscle relaxation (PMR) are two physiotherapeutic approaches that have shown promise in improving sleep quality and reducing discomfort in various populations, but limited evidence exists regarding their impact on pregnant women with RLS. This study will be a randomized controlled trial and will be conducted in the Gynecology and Physiotherapy departments of Valencia Health Clinic, Lahore. Non-probability purposive sampling will be used to collect data. A total of 40 pregnant women aged between 20-35 years, in their 2nd or 3rd trimester and clinically diagnosed with RLS, will be included after fulfilling inclusion and exclusion criteria and giving informed consent. Subjects will be randomly divided into two groups using a random number generator table. Group A will receive supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks. Group B will undergo progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks. Both groups will be assessed at baseline and after the 8-week intervention. Outcome measures will be evaluated using the Pittsburgh Sleep Quality Index (PSQI) for sleep, Fatigue Severity Scale (FSS), Visual Analogue Scale (VAS) for pain, and WHOQOL-BREF for quality of life. Data analysis will be performed using SPSS version 26.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54770
        • Recruiting
        • Valencia health clinic
        • Principal Investigator:
          • Sadia Gulzar, MSWHPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women diagnosed with Restless Leg Syndrome based on clinical criteria.

    • Gestational age between 20 to 34 weeks.
    • Age range between 20-40 years.
    • Experiencing moderate to severe sleep disturbance as per Pittsburgh Sleep Quality Index (PSQI score >5).
    • Complaints of fatigue and generalized discomfort during pregnancy.

Exclusion Criteria:

  • High-risk pregnancy or obstetric complications (e.g., preeclampsia, placenta previa).

    • History of neurological or musculoskeletal disorders unrelated to pregnancy.
    • Any psychiatric disorder or currently taking sedative medications.
    • History of uncontrolled diabetes mellitus or thyroid dysfunction.
    • Participation in any structured exercise program or physiotherapy within the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aerobic exercises
supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks
Other: aerobic exercises
Participants in Group A will receive supervised aerobic exercise in addition to conventional therapy. Mode: Treadmill walking or stationary cycling (based on participant preference and safety). Intensity: Moderate intensity at 50-60% of maximum heart rate (HRmax), calculated as HRmax = 220 - age. Duration: 30 minutes per session. Frequency: 3 sessions per week. Total Duration: 8 weeks. Monitoring: Heart rate monitors will be used to ensure target heart rate is maintained. Each session will be supervised by a qualified physiotherapist. Warm-up and Cool-down: 5-minute warm-up and 5-minute cool-down before and after each session.
Experimental: progressive muscle relaxation
progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.
Other: progressive muscle relaxation

Participants in Group B will receive supervised progressive muscle relaxation (PMR) in addition to conventional therapy. Muscle Groups: 16 major muscle groups will be targeted sequentially, including feet, calves, thighs, hips, abdomen, chest, arms, hands, shoulders, neck, jaw, eyes, forehead, and face. Technique: Each muscle group will be tensed for 5-7 seconds followed by relaxation for 20-30 seconds. Duration: 30 minutes per session. Frequency: 3 sessions per week. Total Duration: 8 weeks.

Monitoring: Sessions will be conducted under supervision to ensure proper technique and participant comfort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index
Time Frame: 8 weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This self-rated questionnaire evaluates sleep quality over a 1-month period. It includes 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. These components are summed to yield a global PSQI score ranging from 0 to 21. A score greater than 5 indicates poor sleep quality. (39)
8 weeks
Fatigue Severity Scale
Time Frame: 8 weeks

Fatigue levels will be assessed using the Fatigue Severity Scale (FSS). The scale includes 9 statements rated on a 7-point Likert scale, where higher scores indicate greater fatigue severity.

The scale focuses on the impact of fatigue on motivation, exercise, physical functioning, and social life.
8 weeks
Numerical Pain Rating Scale
Time Frame: 8 weeks
Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS), a scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their average pain during the past week.
8 weeks
WHOQOL-BREF (Quality of Life)
Time Frame: 8 weeks
Quality of life will be assessed using the WHOQOL-BREF questionnaire. It consists of 26 items covering four domains: physical health, psychological health, social relationships, and environment. Higher scores represent better quality of life.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Hafiza Iqra Rubab, MSWHPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/25/0511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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