Intervenciones Motivacionales y Ejercicio Físico en Pacientes con Fractura por Fragilidad (PREVFRAILTY)
Eficacia de un programa de seguimiento basado en intervenciones motivacionales y ejercicio físico en pacientes con fractura por fragilidad: ensayo clínico controlado aleatorizado.
Patients with a fragility fracture are twice as likely to have future fractures compared to their non-fractured peers. Furthermore, the 30% who suffer a fragility fracture do not regain the level of functioning in terms of activities of daily living after one year. A recent ecological study, in several European countries, estimates that if fracture patients were enrolled in fracture follow-up services, at least 19,000 fractures could be prevented each year. Clinical trials carried out in the research group have shown that the prescription of physical exercise in severe underlying pathologies is effective in improving physical function, quality of life and long-term results.
Hypothesis: The implementation of a motivational intervention and physical exercise program, in a staggered manner, taking into account the basic exercise capacity, improves the functional status of the patient (basic activities of daily life), adherence to interventions and the level of physical activity, and therefore reduces the number of hospital admissions, refractures and other associated complications.
Objective: To evaluate the effect of a rehabilitation intervention based on physical exercise and motivation, applied in a staggered manner and according to the functional capacity of patients with fragility fracture.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Method: Single-blind, randomized, controlled clinical study, with 2 parallel arms and single-center. Study subjects: Patients who underwent surgery for a fragility hip fracture between September 2021 and September 2022 in a tertiary hospital in southern Spain. A progressive physical exercise and motivational intervention adjusted for functional capacity will be compared versus usual rehabilitation care. Follow-up of patients for 3 months and a final visit at 6 months. The primary outcome variables will be functional status for the development of activities of daily living (individual ability to care for himself) and number of hospital readmissions (reasons and consequences). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analyzed.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cordoba
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Córdoba, Cordoba, España, 14004
- Maimónides Biomedical Research Institute of Córdoba
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Present a hip fracture (includes cervical fracture and trochanteric), classified in the 10th version of the International Classification of Diseases (ICD-10-ES) with codes S72-S72.26X;
- In addition, the fracture must be due to fragility: fracture due to a low-energy trauma or not proportional to the consequences (Hermoso de Mendoza, 2003);
- To have received a surgical repair by replacement arthroplasty or internal fixation (ICD-10-ES procedures: 0SU and 0SR) in a period of less than one week;
- To be recovering in a trauma and orthopedic unit and/or be transferred to a rehabilitation unit or discharged;
- Before the fracture, independent or mild dependence for activities of daily living (Barthel index> 60) and living at home;
- To have the cognitive ability to give informed consent (ANNEX I);
- To live and be domiciled in a basic health area covered by the study hospital complex
- To be over 50 years of age
Exclusion Criteria:
- Presence of low cognitive level (scores below 23 points in Lobo's Mini-cognitive exam);
- Patients with pathological fractures due to skeletal alterations other than osteoporosis;
- Presence of more than one fall (other than the cause of hospital admission) in the last year;
- Presence of uncorrected anemia (hemoglobin concentration <9/dL), acute infectious disease (C-reactive protein> 10 mg / L), severe cardiorespiratory disease (for example: unstable angina; severe heart failure identified by the New York Heart Association as class III-IV), musculoskeletal or neurological diseases (for example, major amputation of lower limbs) that make physical exercise impossible.
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: Physical activity program and motivational intervention
Physical activity program agreed with the patient / family and according to functional status (based on the 6-minute walk test) and motivational intervention. In addition to the care provided in usual care, a progressive physical exercise program based on basal functional capacity is prescribed. The exercise will be developed at home. |
Physical and motivational follow-up treatment |
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Comparador activo: Treatment as usual
Multidisciplinary rehabilitation provided by professionals in the hospital and primary care settings, according to the individual needs of patients at different times of their recovery and the accessibility and availability of services in the different care settings. |
Usual rehabilitation program |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Barthel index
Periodo de tiempo: 6 months
|
Functional status for the development of activities of daily living (individual ability to take care of himself) |
6 months
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Number of hospital readmissions
Periodo de tiempo: 6 months
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Other clinical outcomes, such as mortality and all-cause hospitalization, |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mini-Mental State Examination
Periodo de tiempo: 6 months
|
A 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment |
6 months
|
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Minnesota Leisure Time Physical Activity Questionnaire
Periodo de tiempo: 6 months
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To assess the quantity (total activity metabolic index) and quality (heavy, moderate, and light) of physical activity performed |
6 months
|
|
Geriatric Depression Scale
Periodo de tiempo: 6 months
|
is a brief, 30-item questionnaire in which participants are asked to respond by answering yes or no in reference to how they felt over the past week |
6 months
|
|
Visual analogue scale
Periodo de tiempo: 6 months
|
A validated, subjective measure for acute and chronic pain |
6 months
|
|
Falls Efficacy Scale-International
Periodo de tiempo: 6 months
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It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling) |
6 months
|
|
5-level EQ-5D version
Periodo de tiempo: 6 months
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A standardised measure of health-related quality of life |
6 months
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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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
- PIGE-0040-2020
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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