- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07654933
Physiotherapy Effects on Function, Ambulation, and Independence in Palliative Cancer Care
12 de junio de 2026 actualizado por: Nujud Halawi, University of Jazan
Short-Term Effects of Physiotherapy on Functional Status, Ambulation, and Independence in Palliative Care Cancer Patients at Jazan Specialist Hospital: A Prospective Quasi Experimental Study
This study examines the short-term effects of physiotherapy on functional status, ambulation, and independence among patients admitted to the palliative care unit at Jazan Specialist Hospital.
The study hypothesizes that a short-term individualized physiotherapy program will lead to measurable improvements in functional outcomes as assessed by the Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A prospective single-group pre-post quasi-experimental study was conducted in the Palliative Care Unit at Jazan Specialist Hospital, Jazan, Saudi Arabia, between August 2025 and April 2026.
Sixty patients were managed during the study period; of these, 32 patients with complete paired pre- and post-intervention assessments were included in the final statistical analysis.
Patients received an individualized physiotherapy program once daily for one week (7 sessions), with each session lasting approximately 45-60 minutes.
The intervention included range-of-motion exercises, manual therapy, strengthening exercises, stretching, mobility training, transfer training, ambulation exercises, positioning, and chest physiotherapy.
Outcome measures included the Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS).
Pre- and post-intervention data were analyzed using the Wilcoxon signed-rank test.
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Jizan, Arabia Saudita, 86611
- Jazan Health Cluster
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adult patients aged 18 years or older admitted to the palliative care unit with a confirmed diagnosis of advanced cancer.
- Palliative Performance Scale (PPS) score of 40 or above.
- Clinically stable and conscious at the time of recruitment.
- Capable of providing informed consent, either personally or through a legal guardian.
Exclusion Criteria:
1. Pre-terminal or unstable clinical condition that precluded safe physiotherapy participation. 2. PPS score below 40 indicating severely reduced functional status.
3. Unconsciousness or inability to engage meaningfully in physiotherapy sessions.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Otro: Experimental: Physiotherapy Intervention Group
Individualized Physiotherapy Program Participants received an individualized physiotherapy program delivered once daily for one week (7 sessions), each lasting approximately 45-60 minutes.
The program included: range-of-motion exercises, manual therapy, strengthening exercises, stretching, mobility training, transfer training, ambulation exercises, positioning, and chest physiotherapy, as clinically appropriate.
The program was tailored to each patient's functional status, clinical condition, and tolerance, with modifications made according to daily clinical assessment.
Outcome measures: Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS) assessed at baseline (within 24-48 hours of recruitment) and after completion of the one-week intervention (day 7).
|
Individualized Physiotherapy Program Participants received an individualized physiotherapy program delivered once daily for one week (7 sessions), each lasting approximately 45-60 minutes.
The program included: range-of-motion exercises, manual therapy, strengthening exercises, stretching, mobility training, transfer training, ambulation exercises, positioning, and chest physiotherapy, as clinically appropriate.
The program was tailored to each patient's functional status, clinical condition, and tolerance, with modifications made according to daily clinical assessment.
Outcome measures: Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS) assessed at baseline (within 24-48 hours of recruitment) and after completion of the one-week intervention (day 7).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improvement in Barthel Index (BI)
Periodo de tiempo: [Time Frame: Timepoint 1 = Baseline (within 24-48 hours of recruitment). Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
The BI assesses independence in activities of daily living, with higher scores indicating greater independence.
Scores range from 0 to 100.
|
[Time Frame: Timepoint 1 = Baseline (within 24-48 hours of recruitment). Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
|
Improvement in Functional Ambulation Category (FAC)
Periodo de tiempo: [Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
The FAC assesses walking ability and level of assistance required for ambulation.
Scores range from 0 (non-ambulatory) to 5 (independent ambulation on all surfaces).
|
[Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
|
Improvement in Palliative Performance Scale (PPS)
Periodo de tiempo: [Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
The PPS assesses overall functional status in palliative care, with higher scores indicating better functional performance.
Scores range from 0 to 100 in increments of 10.
|
[Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nujud Halawi, University of Jazan
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2025
Finalización primaria (Actual)
30 de abril de 2026
Finalización del estudio (Actual)
13 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UJazan_NHalawi
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .