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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07642089
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Imran Amjad, PHD*
- Número de teléfono: 03324390125
- Correo electrónico: imran.amjad@riphah.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Imran Amjad, PHD*
- Número de teléfono: 0515481826
- Correo electrónico: imran.amjad@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Reclutamiento
- National Hospital
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Contacto:
- Ghulam Fatima, PhD*
- Número de teléfono: 03034073057
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group A (Static Stretching)
Group A will perform static stretching exercises targeting the lower limb muscles
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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. |
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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International Restless Legs Syndrome Rating Scale (IRLS-RS)
Periodo de tiempo: 6 weeks
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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
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Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 6 weeks
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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
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6 weeks
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Fatigue Severity Scale (FSS)
Periodo de tiempo: 6 weeks
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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.
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Fatima Javed, MS*, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Parasomnias
- Trastornos de iniciación y mantenimiento del sueño
- Síndrome de piernas inquietas
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
- Ejercicios de estiramiento muscular
Otros números de identificación del estudio
- REC/RCR & AHS/25/0524
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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