Effects of Static Stretching and Strength Training on Antenatal Restless Leg Syndrome

Official title

Effects of Statics Stretching With and Without Strength Training on Symptom Severity, Fatigue and Sleep Quality in Antenatal Restless Leg Syndrome

Overview

Restless Legs Syndrome (RLS) is a prevalent sensorimotor disorder affecting pregnant women, particularly in the third trimester, and is associated with sleep disturbances, fatigue and reduced quality of life. Non-pharmacological strategies such as stretching and strength training offer promising alternatives during pregnancy. This randomized controlled trial aims to compare the effects of static stretching alone and static stretching combined with strength training on sleep quality, symptom severity and fatigue in antenatal women with RLS. Thirty pregnant women meeting the diagnostic criteria for RLS will be recruited from National Hospital and medical center and randomly assigned into two groups. Group A will receive static stretching exercises, while Group B will receive static stretching and lower limb strength training exercises for 6 weeks, three sessions per week. Data will be analyzed using SPSS, with a p-value \< 0.05 considered statistically significant.

Detailed description

Restless Legs Syndrome (RLS) is a prevalent sensorimotor disorder affecting pregnant women, particularly in the third trimester and is associated with sleep disturbances, fatigue and reduced quality of life. Although pharmacological treatments are limited during pregnancy due to safety concerns, non-pharmacological strategies such as stretching and strength training offer promising alternatives. This randomized controlled trial aims to evaluate and compare the effects of static stretching alone and static stretching combined with strength training on sleep quality, symptom severity and fatigue in antenatal women diagnosed with RLS. A total of 30 pregnant women in their second or third trimester, meeting the diagnostic criteria for Restless Legs Syndrome (RLS), will be recruited for the study. The data will be collected from National Hospital and medical center and participants will be randomly assigned into two equal groups. Group A will receive a static stretching exercise regimen, while Group B will receive both static stretching and lower limb strength training exercises. The intervention will be carried out over a 6-week period, with three supervised sessions per week. Data will be analyzed using SPSS. Descriptive statistics will summarize demographic details. Paired t-tests or non-parametric tests will compare baseline and post-intervention scores using validated tools: IRLS-RS, PSQI, and FSS. A p-value \< 0.05 will indicate statistical significance.

Interventions

• Other Static Stretching
  Each session for Group A will begin with a brief warm-up consisting of five minutes of light walking, followed by static stretching of major lower limb muscles including the hamstrings, quadriceps, calf muscles, hip flexors, tibialis anterior, and lower back muscles. The hamstrings can be stretched by sitting or standing forward bends; the quadriceps can be extended by standing from heel to buttocks; and the calf muscles can be stretched by lunging against a wall. Additionally, a kneeling lunge
• Other Static Stretching + Strength Training
  Group B will receive the same stretching protocol as Group A but will also engage in a structured strength training program targeting the lower limbs. Each strengthening exercise session will include seated ankle dorsiflexion using resistance bands to activate the tibialis anterior muscle, standing calf raises to strengthen the gastrocnemius and soleus muscles and glute bridges to target the gluteal and hamstring groups. Additionally, participants will perform wall squats to engage the quadricep

Primary outcome measures

• International Restless Legs Syndrome Rating Scale (IRLS-RS) [Time frame: 6 weeks]
• Pittsburgh Sleep Quality Index (PSQI) [Time frame: 6 weeks]
• Fatigue Severity Scale (FSS) [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

• Pregnant women aged 18-35 years.
• Gestational age between 24 and 32 weeks.
• Diagnosed with RLS based on the International Restless Legs Syndrome Study Group (IRLSSG) criteria.
• Experiencing sleep disturbances and fatigue related to RLS.

Exclusion criteria

• High-risk pregnancies or obstetric complications.
• Pre-existing neurological or musculoskeletal disorders.
• Engagement in regular exercise routines prior to the study.
• Contraindications to exercise as determined by a healthcare provider.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• National Hospital — Lahore

Publications

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• Cuttino JT, Scatliff JH. First year radiology residents: PGI vs. PGII. AJR Am J Roentgenol. 1979 May;132(5):855-6. doi: 10.2214/ajr.132.5.855. No abstract available. PMID 107768

Identifiers

NCT: NCT07642089 · REC/RCR & AHS/25/0524

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗