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

NCT07628387 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0511
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Restless Leg Syndrome in Pregnancy

Keywords

restless leg syndrome; pregnancy; Sleep quality of life; Fatigue; Pain; Muscle Relaxation

Outcome Measures

Primary Outcomes (4)

• Pittsburgh Sleep Quality Index

  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

  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

  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)

  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

Study Arms (2)

aerobic exercises

ACTIVE COMPARATOR

supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks

Other: aerobic exercises

progressive muscle relaxation

EXPERIMENTAL

progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.

Other: progressive muscle relaxation

Interventions

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.

aerobic exercises

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.

progressive muscle relaxation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Age range between 20-40 years, Pregnant women diagnosed with Restless Leg Syndrome based on clinical criteria and Gestational age between 20 and 34 weeks.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Valencia health clinic

Lahore, Punjab Province, 54770, Pakistan

RECRUITING

Related Publications (5)

• Mislu E, Assalfew B, Arage MW, Chane F, Hailu T, Tenaw LA, Kidie AA, Kumsa H. Prevalence and factors associated with restless legs syndrome among pregnant women in middle-income countries: a systematic review and meta-analysis. Front Med (Lausanne). 2023 Dec 21;10:1326337. doi: 10.3389/fmed.2023.1326337. eCollection 2023.

  PMID: 38188334 BACKGROUND

• Dewald-Kaufmann J, de Bruin E, Michael G. Cognitive Behavioral Therapy for Insomnia in School-Aged Children and Adolescents. Sleep Med Clin. 2022 Sep;17(3):355-365. doi: 10.1016/j.jsmc.2022.06.003.

  PMID: 36150799 BACKGROUND

• Luo Y, Du J, Wang J, Liu P, Shi Z, He Y, Che G, Huang K, Wang J. Progressive muscle relaxation alleviates anxiety and improves sleep quality among healthcare practitioners in a mobile cabin hospital: a pre-post comparative study in China. Front Psychol. 2024 Apr 30;15:1337318. doi: 10.3389/fpsyg.2024.1337318. eCollection 2024.

  PMID: 38746917 BACKGROUND

• Sweet L, O'Driscoll K, Blums T, Sommeling M, Kolar R, Teale G, Wynter K. Relationships are the key to a successful publicly funded homebirth program, a qualitative study. Women Birth. 2023 Jul;36(4):377-384. doi: 10.1016/j.wombi.2022.12.005. Epub 2023 Jan 4.

  PMID: 36604197 BACKGROUND

• Khan IA, Khan M, Raza F, Sheikh MLJMJoN. Enhancing Management of Restless Legs Syndrome through Complementary Physical Therapy: Toward Better Outcomes in a Distressing Sensorimotor Disorder. 2025;9(1):1-17.

  BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome; Fatigue; Pain

Interventions

Exercise; Autogenic Training

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hafiza Iqra Rubab, MSWHPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: October 1, 2025
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)