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

NCT07642089 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0524
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Restless Leg Syndrome

Keywords

Resistance training; Sleep quality; Muscle Stretching Exercise

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group A (Static Stretching)

EXPERIMENTAL

Group A will perform static stretching exercises targeting the lower limb muscles

Other: Static Stretching

Group B (Static Stretching + Strength Training)

ACTIVE COMPARATOR

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

Interventions

Static Stretching OTHER

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.

Group A (Static Stretching)

Static Stretching + Strength Training OTHER

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.

Group B (Static Stretching + Strength Training)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

National Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (4)

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  PMID: 86073 BACKGROUND

• 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.

  PMID: 1120420 BACKGROUND

• 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.

  PMID: 134959 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Initiation and Maintenance Disorders

Interventions

Muscle Stretching Exercises; Resistance Training

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human

Study Officials

• Fatima Javed, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD*

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Imran Amjad, PHD*

CONTACT

0515481826; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: April 2, 2025
• Primary Completion: July 2, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)