- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07754149
Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr.Rida Zafar, MSWHPT
- Número de teléfono: 03368753273
- Correo electrónico: rida.zafar@riphah.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Dr Summra Andleeb, MS-OMPT
- Número de teléfono: 0345-0617872
- Correo electrónico: sammra.andleeb@riphah.edu.pk
Ubicaciones de estudio
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Federal
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Islamabad, Federal, Pakistán, 051
- Reclutamiento
- Kens college model town humak and community model town
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Contacto:
- Dr.Rida Zafar
- Número de teléfono: 03368753273
- Correo electrónico: rida.zafar@riphah.edu.pk
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Islamabad, Federal, Pakistán, 051
- Reclutamiento
- Kid city high school
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Contacto:
- Dr.Rida Zafar
- Número de teléfono: 03368753273
- Correo electrónico: rida.zafar@riphah.edu.pk
-
Investigador principal:
- Amina Rizwan, MSPT(WH)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosed with Premenstrual Syndrome (PMS) based on PSST screening tool.
- Not currently engaged in any structured resistance or exercise training program.
- Medically cleared to participate in moderate-intensity resistance training.
- Provided written informed consent for participation.
Exclusion Criteria:
- Current use of hormonal therapy or oral contraceptives.
- History of endocrine disorders (e.g., PCOS, thyroid dysfunction).
- Any musculoskeletal or cardiovascular condition limiting exercise participation.
- Ongoing psychiatric medication or diagnosed depression/anxiety disorder.
- Participation in a structured exercise or resistance training program within the last 3 months.
- Use of analgesics, anti-inflammatory, or hormonal medications during the study period.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Progressive Resistance Training Group
Participants allocated to this arm will receive a supervised 6-week progressive resistance training program performed three times per week on non-consecutive days.
Each session will last 45-60 minutes.
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A supervised progressive resistance training program delivered three sessions per week for six weeks. Exercise intensity is gradually increased using the Borg Rating of Perceived Exertion (RPE) scale. A warm up session will be done before resistance training exercise and Cool down for 5-10 minutes will be done exercise. Participants will follow the FITT prescription for their resistance exercises. Week 1-2 (DOSE 1) Intensity: Low. Bodyweight or dumbbells (RPE 7-11/20). Sets & Reps: 2 sets of 25-30 reps. Volume: High. Focus on mastering technique. Week 3-4 (DOSE 2) Intensity: moderate. Bodyweight or dumbbells (RPE 12-14/20). Sets & Reps: 2 sets of 20-25 repetitions. Volume: Moderate. Focus on mastering technique. Week 5-6(DOSE 3) Intensity: high. Dumbbells (RPE 15-16/20). Sets & Reps: 2 sets of 15-20 repetitions. Volume: Low. |
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Comparador activo: Low-Intensity Resistance Training Group
Participants allocated to this arm will receive a supervised low-intensity resistance training program for six weeks.
Sessions will be conducted three times per week, lasting 45-60 minutes each.
Participants will perform the same standardized resistance exercises as the experimental group; however, exercise intensity will remain low throughout the intervention without progressive overload.
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Participants of this group will receive the same standardized exercises as the experimental group. Exercise intensity remains constant at low intensity throughout the intervention period without progressive increase. Before exercise the participants will perform warm up and after exercise they will perform cool down, same as the experimental group. The FITT protocol for this group is as following: Week 1-2 (DOSE1) Intensity: low Body weight. or Dumbbells (RPE 7-11/20). Sets & Reps: 2 sets of 15repetitions. Volume: Low. Focus on mastering technique. Week 3-4 (DOSE 2) Intensity: low. Bodyweight or dumbbells (RPE 7-11/20). Sets & Reps: 2 sets of 20 repetitions. Volume: Moderate. Focus on mastering technique Week 5-6(DOSE 3) Intensity: Low. Bodyweight or dumbbells (RPE 7-11/20). Sets & Reps: 2 sets of 25 reps. Volume: High. Focus on mastering technique. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Premenstrual Symptoms Screening Tool (PSST)
Periodo de tiempo: Assessments will be conducted at baseline, week 2, week 4, week 6, and at 3-month follow-up
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The primary outcome of this study is the severity of premenstrual syndrome symptoms, measured using the Premenstrual Symptoms Screening Tool (PSST).
The PSST is a self-reported questionnaire used to assess physical, psychological, and behavioral symptoms related to PMS, including mood swings, irritability, anxiety, fatigue, bloating, breast tenderness, and difficulty concentrating.
It also evaluates how these symptoms affect daily activities, school performance, and social relationships.
Each item is scored on a 4-point Likert scale ranging from "none" to "severe."
Higher scores indicate greater PMS severity..
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Assessments will be conducted at baseline, week 2, week 4, week 6, and at 3-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Life (QoL)
Periodo de tiempo: Quality of life will be assessed at baseline, immediately after the 6-week intervention, and at 3-month follow-up using the WHOQOL-BREF questionnaire.
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Quality of life will be assessed using the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF).
This questionnaire contains 26 items and evaluates four domains: physical health, psychological health, social relationships, and environmental well-being.
Each item is rated on a 5-point Likert scale, with higher scores representing better quality of life.
The WHOQOL-BREF is a reliable and valid tool commonly used in clinical and research settings to assess overall well-being.
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Quality of life will be assessed at baseline, immediately after the 6-week intervention, and at 3-month follow-up using the WHOQOL-BREF questionnaire.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rida Zafar, WHPT, Riphah International University
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
Otros números de identificación del estudio
- Amina Rizwan
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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