Aerobic exercise vs. muscle-relaxation therapy for restless legs in pregnancy
Official 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
Run by Riphah International University · NCT07628387 · Data updated 2026-11-12
This trial tests whether supervised aerobic exercise or progressive muscle relaxation can help pregnant women with restless legs syndrome.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07628387 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women aged 20-40 in 2nd–3rd trimester (20-34 weeks) with clinically diagnosed RLS and moderate-to-severe sleep disturbance who are not in high-risk pregnancies and not currently in a structured exercise program.
✕Probably not a fit
Some participants may not experience noticeable improvement in symptoms or sleep quality despite adherence to the assigned intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares two non-drug interventions for restless legs syndrome during pregnancy. Forty pregnant women in the 2nd or 3rd trimester with clinically diagnosed RLS will be randomly assigned to either supervised aerobic exercises or progressive muscle relaxation for eight weeks, with sessions three times weekly. Outcomes will be measured at baseline and after the 8-week program, focusing on sleep quality, fatigue, and comfort. The study is conducted at Valencia Health Clinic in Lahore with non-probability purposive sampling to enroll eligible participants who provide informed consent.
Why it matters
Potential benefit: If successful, the interventions could improve sleep quality and reduce discomfort for pregnant individuals with RLS.
How similar studies have gone: Previous work suggests non-pharmacologic approaches like exercise and relaxation can help with sleep and discomfort, but data specific to pregnancy-related RLS are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Valencia health clinic
Lahore, Punjab Province, Pakistan Recruiting
Study contacts
- Principal investigator: Hafiza Iqra Rubab, MSWHPT — Riphah International University
- Study coordinator: Imran Amjad, PhD
- Email: imran.amjad@riphah.edu.pk
- Phone: 03324390125
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.