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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Restless Leg Syndrome
• Intervention / Treatment: Other: Static Stretching; Other: Static Stretching + Strength Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PHD*; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk
• Study Contact Backup: Name: Imran Amjad, PHD*; Phone Number: 0515481826; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Recruiting
      • National Hospital
      • Contact: Ghulam Fatima, PhD*; Phone Number: 03034073057

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Static Stretching); Group A will perform static stretching exercises targeting the lower limb muscles	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 position will be used to stretch the hip flexors, and toe-point or sitting plantarflexion stretches will be used to target the tibialis anterior muscles. The Cat-Cow movement and Child's Pose will help increase lower back flexibility. Each stretch will be held for 20-30 seconds and repeated 2-3 times per muscle group.
Active Comparator: Group B (Static Stretching + Strength Training); group B will perform the same static stretching exercises as Group A. along with that they will also engage in strength training exercises using resistance bands focusing on lower limb muscles.	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 quadriceps and core muscles in a low-impact manner, and seated leg extensions using resistance bands to strengthen the knee extensors. Each exercise will be performed in 2-3 sets of 10-12 repetitions, with 30-60 seconds rest between sets. Resistance bands will be used and progressively upgraded over the weeks based on individual tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Restless Legs Syndrome Rating Scale (IRLS-RS)	The IRLS-RS is a 10-item self-reported questionnaire developed by the International Restless Legs Syndrome Study Group to assess the severity of RLS symptoms. Each item is rated on a 5-point Likert scale from 0 (no symptoms) to 4 (very severe symptoms), with a total possible score of 40. Scores between 0-10 are classified as mild, 11-20 moderate, 21-30 severe, and 31-40 very severe RLS. The IRLS-RS has demonstrated strong internal consistency (Cronbach's α = 0.81) and interrater reliability (ICC = 0.87), making it suitable for use in antenatal populations.	6 weeks
Pittsburgh Sleep Quality Index (PSQI)	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire that measures seven domains of sleep, including sleep latency, duration, efficiency, disturbances, and daytime dysfunction. The total score ranges from 0 to 21, with scores above 5 indicating poor sleep quality. The PSQI is widely used in both clinical and research settings and has demonstrated strong psychometric properties, including a Cronbach's alpha of 0.83 and test retest reliability of 0.85. It is also validated for use in pregnant populations	6 weeks
Fatigue Severity Scale (FSS)	Fatigue levels will be measured using the Fatigue Severity Scale (FSS), a 9-item instrument assessing the impact of fatigue on daily life. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), and the final score is the average of all items. A score of ≥4 indicates clinically significant fatigue. The FSS has high internal consistency (Cronbach's α ranging from 0.88 to 0.93) and has been validated in various populations, including pregnant and neurological patients.	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Fatima Javed, MS*, Riphah International University

Publications and helpful links

General Publications

• Krauthammer C, Klerman GL. Mania secondary to thyroid disease. Lancet. 1979 Apr 14;1(8120):827-8. doi: 10.1016/s0140-6736(79)91348-5. No abstract available.
• Brodsky L, Zuniga J. Nitrous oxide: a psychotogenic agent. Compr Psychiatry. 1975 Mar-Apr;16(2):185-8. doi: 10.1016/0010-440x(75)90065-6. No abstract available.
• Freyschmidt J, Saure D, Hagemann G. [New intensifying screens in clinical radiology. II. Examinations in clinical practice]. Rofo. 1976 Sep;125(3):279-84. doi: 10.1055/s-0029-1230462. German.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sleep quality; Resistance training; Muscle Stretching Exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders; Restless Legs Syndrome; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training; Muscle Stretching Exercises
• Other Study ID Numbers: REC/RCR & AHS/25/0524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No