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

4 juin 2026 mis à jour par: Riphah International University

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

This study will be a randomized controlled trial and will be conducted in the Gynecology and Physiotherapy departments of Valencia Health Clinic, Lahore. Non-probability purposive sampling will be used to collect data. A total of 40 pregnant women aged between 20-35 years, in their 2nd or 3rd trimester and clinically diagnosed with RLS, will be included after fulfilling inclusion and exclusion criteria and giving informed consent. Subjects will be randomly divided into two groups using a random number generator table. Group A will receive supervised aerobic exercises for 8 weeks while Group B will undergo progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks. Both groups will be assessed at baseline and after the 8-week intervention.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Restless Legs Syndrome (RLS) is a neurological disorder that often worsens during pregnancy, particularly in the second and third trimesters. It is characterized by an uncontrollable urge to move the legs, often accompanied by discomfort or pain, and is known to disrupt sleep, increase fatigue, and negatively affect the quality of life. Pharmacological treatments for RLS during pregnancy are limited due to safety concerns, creating a need for effective, non-drug interventions. Aerobic exercise and progressive muscle relaxation (PMR) are two physiotherapeutic approaches that have shown promise in improving sleep quality and reducing discomfort in various populations, but limited evidence exists regarding their impact on pregnant women with RLS. This study will be a randomized controlled trial and will be conducted in the Gynecology and Physiotherapy departments of Valencia Health Clinic, Lahore. Non-probability purposive sampling will be used to collect data. A total of 40 pregnant women aged between 20-35 years, in their 2nd or 3rd trimester and clinically diagnosed with RLS, will be included after fulfilling inclusion and exclusion criteria and giving informed consent. Subjects will be randomly divided into two groups using a random number generator table. Group A will receive supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks. Group B will undergo progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks. Both groups will be assessed at baseline and after the 8-week intervention. Outcome measures will be evaluated using the Pittsburgh Sleep Quality Index (PSQI) for sleep, Fatigue Severity Scale (FSS), Visual Analogue Scale (VAS) for pain, and WHOQOL-BREF for quality of life. Data analysis will be performed using SPSS version 26.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54770
        • Recrutement
        • Valencia health clinic
        • Chercheur principal:
          • Sadia Gulzar, MSWHPT

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: aerobic exercises
supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks
Autre: aerobic exercises
Participants in Group A will receive supervised aerobic exercise in addition to conventional therapy. Mode: Treadmill walking or stationary cycling (based on participant preference and safety). Intensity: Moderate intensity at 50-60% of maximum heart rate (HRmax), calculated as HRmax = 220 - age. Duration: 30 minutes per session. Frequency: 3 sessions per week. Total Duration: 8 weeks. Monitoring: Heart rate monitors will be used to ensure target heart rate is maintained. Each session will be supervised by a qualified physiotherapist. Warm-up and Cool-down: 5-minute warm-up and 5-minute cool-down before and after each session.
Expérimental: progressive muscle relaxation
progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.
Autre: progressive muscle relaxation

Participants in Group B will receive supervised progressive muscle relaxation (PMR) in addition to conventional therapy. Muscle Groups: 16 major muscle groups will be targeted sequentially, including feet, calves, thighs, hips, abdomen, chest, arms, hands, shoulders, neck, jaw, eyes, forehead, and face. Technique: Each muscle group will be tensed for 5-7 seconds followed by relaxation for 20-30 seconds. Duration: 30 minutes per session. Frequency: 3 sessions per week. Total Duration: 8 weeks.

Monitoring: Sessions will be conducted under supervision to ensure proper technique and participant comfort.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pittsburgh Sleep Quality Index
Délai: 8 weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This self-rated questionnaire evaluates sleep quality over a 1-month period. It includes 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. These components are summed to yield a global PSQI score ranging from 0 to 21. A score greater than 5 indicates poor sleep quality. (39)
8 weeks
Fatigue Severity Scale
Délai: 8 weeks

Fatigue levels will be assessed using the Fatigue Severity Scale (FSS). The scale includes 9 statements rated on a 7-point Likert scale, where higher scores indicate greater fatigue severity.

The scale focuses on the impact of fatigue on motivation, exercise, physical functioning, and social life.
8 weeks
Numerical Pain Rating Scale
Délai: 8 weeks
Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS), a scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their average pain during the past week.
8 weeks
WHOQOL-BREF (Quality of Life)
Délai: 8 weeks
Quality of life will be assessed using the WHOQOL-BREF questionnaire. It consists of 26 items covering four domains: physical health, psychological health, social relationships, and environment. Higher scores represent better quality of life.
8 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Riphah International University

Les enquêteurs

  • Chercheur principal: Hafiza Iqra Rubab, MSWHPT, Riphah International University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2025

Achèvement primaire (Estimé)

1 juillet 2026

Achèvement de l'étude (Estimé)

1 juillet 2026

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • REC/RCR & AHS/25/0511

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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