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NCT Number: NCT07628387

Comparative Effects of Aerobic and Muscle Relaxation Exercises 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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Valencia health clinic

Lahore, Punjab Province, 54770, Pakistan

Location status: Recruiting

Location contact

Sadia Gulzar, MSWHPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aerobic exercises

Other

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.

Progressive Muscle Relaxation

Other

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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