Actively Recruiting

Phase Not Applicable
Age: 20Years - 40Years
FEMALE
ID07628387

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

Led by Riphah International University · Updated on 2026-06-05

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates the effects of aerobic exercise versus progressive muscle relaxation on pregnant women diagnosed with Restless Leg Syndrome (RLS) during their second or third trimester. RLS is a neurological condition that causes an uncontrollable urge to move the legs, often with discomfort, disrupting sleep and quality of life. Due to limited drug options during pregnancy, the study aims to evaluate these two non-drug therapies to improve sleep quality, reduce fatigue and pain, and enhance overall quality of life. Participants will be randomly assigned to one of two groups. Group A will engage in supervised aerobic exercises such as brisk walking, cycling, and step-ups, at moderate intensity with heart rate monitoring, for 30 minutes per session, three times a week for eight weeks. Group B will undergo supervised progressive muscle relaxation sessions targeting 16 major muscle groups, with specific tension and relaxation phases, for 30 minutes per session, also three times a week for eight weeks. Both groups will receive conventional therapy alongside these interventions. Women in the study will be assessed at the start and end of the 8-week intervention period. Researchers will measure sleep quality using the Pittsburgh Sleep Quality Index, fatigue levels with the Fatigue Severity Scale, pain intensity with a Visual Analogue Scale, and quality of life via the WHOQOL-BREF questionnaire. Data will be collected and analyzed using SPSS software. This study is conducted at the Valencia Health Clinic in Lahore and sponsored by Riphah International University.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women diagnosed with Restless Leg Syndrome based on clinical criteria
  • Gestational age between 20 to 34 weeks
  • Age between 20 and 40 years
  • Experiencing moderate to severe sleep disturbance (Pittsburgh Sleep Quality Index score greater than 5)
  • Complaints of fatigue and generalized discomfort during pregnancy
Not Eligible

You will not qualify if you...

  • High-risk pregnancy or obstetric complications such as preeclampsia or 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive supervised aerobic exercises or progressive muscle relaxation sessions three times a week for 8 weeks to improve sleep quality, reduce fatigue, and alleviate pain associated with Restless Leg Syndrome during pregnancy.

3 sessions per week

Trial Site Locations

Total: 1 location

1

Valencia health clinic

Lahore, Punjab Province, Pakistan, 54770

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Research Team

I

Imran Amjad, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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