- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07596602
Machine-Based Pilates on Quality of Life and Low Back Pain in Older Adults (Pilates-LBP)
Feasibility and Preliminary Outcomes of a Machine-Based Pilates Program on Quality of Life and Low Back Pain in Aged Adults: A Mixed-Methods Approach
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is designed as an exploratory, quasi-experimental, single-arm pilot study. Participants presenting with moderate disability caused by low back pain (Oswestry Disability Index = 21% to 40%) will undergo a structured exercise protocol utilizing the Classical Pilates method on machines in a one-on-one setting. The intervention spans 12 weeks, consisting of two individual 50-minute sessions per week.
The pedagogical structure is divided into two distinct Classical approach components: the "Skeleton" (core base exercises on the Reformer and Mat) and the "System" (adaptations and specific exercises on auxiliary equipment like the Wunda Chair, Cadillac, and Barrels). Exercise progression is individualized based on biomechanical control, absence of pain, and ability to maintain a neutral lumbopelvic position. Resistance is modified primarily via adjustable springs on the equipment. Exercise intensity is strictly monitored using the Talk Test to ensure a light-to-moderate exertion level suitable for the geriatric demographic.
Assessments are conducted at baseline and post-intervention (12 weeks) using the WHOQOL-Bref for quality of life and the Oswestry Disability Index Version 2.0 for low back pain disability. Additionally, a qualitative focus group will be conducted post-intervention with a subsample of participants to capture contextual insights regarding mobility, psychosocial benefits, and daily habit integration.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Leiria District
-
Leiria, Leiria District, Portugal, 2411-901
- Instituto Politécnico de Leiria
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged between 55 and 75 years.
- Physically active in daily routines.
- No previous experience with machine-based Pilates.
- Presenting with moderate disability (Oswestry Disability Index = 21% to 40%) caused by low back pain.
Exclusion Criteria:
- Absolute contraindications to physical exercise.
- Severe spinal pathologies (e.g., hernias requiring surgery, severe osteoporosis, idiopathic scoliosis).
- Previous or scheduled spinal surgeries.
- Severe disability (Oswestry Disability Index > 41%).
- Chronic obstructive pulmonary disease.
- Recent stroke or myocardial infarction.
- Uncontrolled hypertension.
- Active oncological treatment.
- Physical therapy treatment for low back pain within the six months prior to the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Machine-Based Pilates Group
A 12-week program consisting of two individual 50-minute sessions per week.
The protocol integrates "Skeleton" exercises (Mat and Reformer) and "System" exercises (auxiliary equipment).
The periodization varies the positional stimulus (starting on Mat for the first 6 weeks, and starting on Reformer for the final 6 weeks).
Intensity is maintained at a light-to-moderate level, monitored continuously via the Talk Test.
|
A 12-week program consisting of two individual 50-minute sessions per week.
The protocol integrates "Skeleton" exercises (Mat and Reformer) and "System" exercises (auxiliary equipment).
The periodization varies the positional stimulus (starting on Mat for the first 6 weeks, and starting on Reformer for the final 6 weeks).
Intensity is maintained at a light-to-moderate level, monitored continuously via the Talk Test.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Quality of Life
Periodo de tiempo: Baseline (Week 0) and Post-Intervention (Week 13).
|
Assessed using the World Health Organization Quality of Life Brief (WHOQOL-Bref) questionnaire.
It evaluates four domains: physical, psychological, social relationships, and environment.
Responses for each item are recorded on a five-point scale ranging from 1 (minimum) to 5 (maximum), and the total domain scores are transformed to a 0 to 100 scale, where 0 is the minimum possible score and 100 is the maximum possible score.
Higher scores indicate a better perceived quality of life.
|
Baseline (Week 0) and Post-Intervention (Week 13).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: José Carlos Laranjo Marques, ESECS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- CE/IPLEIRIA/62/2023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .