- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07628387
Comparative Effects of Aerobic and Muscle Relaxation Exercises in Pregnant Women With Restless Leg Syndrome
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
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
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54770
- Reclutamiento
- Valencia health clinic
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Investigador principal:
- Sadia Gulzar, MSWHPT
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: aerobic exercises
supervised aerobic exercises (brisk walking, cycling, step-ups, etc.) 3 times a week for 8 weeks
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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.
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Experimental: progressive muscle relaxation
progressive muscle relaxation sessions of 20- 25 minutes, also 3 times a week for 8-weeks.
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Periodo de tiempo: 8 weeks
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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)
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8 weeks
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Fatigue Severity Scale
Periodo de tiempo: 8 weeks
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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
|
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Numerical Pain Rating Scale
Periodo de tiempo: 8 weeks
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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.
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8 weeks
|
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WHOQOL-BREF (Quality of Life)
Periodo de tiempo: 8 weeks
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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.
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8 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hafiza Iqra Rubab, MSWHPT, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- Mislu E, Assalfew B, Arage MW, Chane F, Hailu T, Tenaw LA, Kidie AA, Kumsa H. Prevalence and factors associated with restless legs syndrome among pregnant women in middle-income countries: a systematic review and meta-analysis. Front Med (Lausanne). 2023 Dec 21;10:1326337. doi: 10.3389/fmed.2023.1326337. eCollection 2023.
- Dewald-Kaufmann J, de Bruin E, Michael G. Cognitive Behavioral Therapy for Insomnia in School-Aged Children and Adolescents. Sleep Med Clin. 2022 Sep;17(3):355-365. doi: 10.1016/j.jsmc.2022.06.003.
- Luo Y, Du J, Wang J, Liu P, Shi Z, He Y, Che G, Huang K, Wang J. Progressive muscle relaxation alleviates anxiety and improves sleep quality among healthcare practitioners in a mobile cabin hospital: a pre-post comparative study in China. Front Psychol. 2024 Apr 30;15:1337318. doi: 10.3389/fpsyg.2024.1337318. eCollection 2024.
- Sweet L, O'Driscoll K, Blums T, Sommeling M, Kolar R, Teale G, Wynter K. Relationships are the key to a successful publicly funded homebirth program, a qualitative study. Women Birth. 2023 Jul;36(4):377-384. doi: 10.1016/j.wombi.2022.12.005. Epub 2023 Jan 4.
- Khan IA, Khan M, Raza F, Sheikh MLJMJoN. Enhancing Management of Restless Legs Syndrome through Complementary Physical Therapy: Toward Better Outcomes in a Distressing Sensorimotor Disorder. 2025;9(1):1-17.
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
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Parasomnias
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor
- Fatiga
- Síndrome de piernas inquietas
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Hipnosis
- Ejercicio
- Entrenamiento autogénico
Otros números de identificación del estudio
- REC/RCR & AHS/25/0511
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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