- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01669395
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Approximately 400,000 Danes live today with heart disease. Disease severity is crucial for patients quality of life. Patients with severe heart disease often struggle with everyday life, characterized by reduced physical capacity, tendency to depression and anxiety to perform everyday activities that may provoke symptoms.
A large proportion of patients who are offered cardiac rehabilitation deselect that offer. Of the patients who do participate, more than 50% stop the rehabilitation ahead of time. A large group of patients with severe heart failure and classified in NYHA Class III and IV, deselect the offer because of lack of energy to participate in cardiac rehabilitation or is when specified by a medical assessment discharged from the hospital without the offer of training or any other form of rehabilitation.
The offer of rehabilitation for patients with severe heart failure is lacking as it is today. This study assesses the effectiveness of an early home based rehabilitation program that complements the general psycho-social support, symptom-oriented and preventive medical treatment that these patients always have the option to get.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Laura Staun Valentiner, Master in health scien
- Número de teléfono: + 45 39 77 39 51
- Correo electrónico: laura.risted.staun.valentiner@regionh.dk
Copia de seguridad de contactos de estudio
- Nombre: Carsten Juhl, Ph.D.stud
- Número de teléfono: + 45 39 77 39 51
- Correo electrónico: carsten.juhl@regionh.dk
Ubicaciones de estudio
-
-
Gentofte
-
Copenhagen, Gentofte, Dinamarca, 2900
- Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,
-
Contacto:
- Laura Staun Valentiner, masters in health sciences
- Número de teléfono: + 45 39 77 39 51
- Correo electrónico: laura.risted.staun.valentiner@regionh.dk
-
Contacto:
- Carsten Juhl, Ph.D stud.
- Número de teléfono: + 45 39 77 39 51
- Correo electrónico: carsten.juhl@regionh.dk
-
Investigador principal:
- Laura Staun Valentiner, Masters in Health Science
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients admitted to the Gentofte Hospital due to heart failure.
- Patients with a functional equivalent to NYHA grade III or IV
- Patients with ejection fraction <40%
- Patients who score between10-15 in the total score for question 3 dealing with physical functioning in SF-36 questionnaire on health status
- Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality.
- Patients who can speak and understand Danish
Exclusion Criteria:
- Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression).
- Patients with terminal illness with expected death within a year.
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 |
---|---|
Experimental: Early homebased rehabilitation
After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
|
Training begins 3-5 days after discharge from hospital, performed by an occupational therapist and a physiotherapist from Gentofte Hospital in the first two weeks.
From week three to six the training will be carried out by an occupational therapist and a physiotherapist from the local municipality (Gentofte municipality and Lyngby Taarbæk municipality).
Training will take place at home twice a week for 6 weeks, each session lasting 45 minutes.
The intervention is individualized and focuses on functional physical and compensatory training to help the patient to manage everyday life at home.
A training program will be provided and the patient will be instructed to do the exercises every day
Otros nombres:
|
Experimental: control group: Ususal care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
|
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Readmission due to heart failure
Periodo de tiempo: assessed one year after inclusion
|
assessed one year after inclusion
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Physical capacity
Periodo de tiempo: Assessed at baseline, after 6 weeks, after 6 month and after one year
|
measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test
|
Assessed at baseline, after 6 weeks, after 6 month and after one year
|
Activity of Daily Living
Periodo de tiempo: Assessed at baseline, after 6 weeks, after 6 month and after one year
|
Recorded at an ADL interview to assess the performance of everyday activities
|
Assessed at baseline, after 6 weeks, after 6 month and after one year
|
Number of total hospital admissions
Periodo de tiempo: at baseline, after 6 weeks, after 6 month and after one year
|
at baseline, after 6 weeks, after 6 month and after one year
|
|
Exercise Compliance
Periodo de tiempo: at baseline, after 6 weeks, after 6 month and after one year
|
registration of exercise
|
at baseline, after 6 weeks, after 6 month and after one year
|
Anxiety and depression
Periodo de tiempo: at baseline, after 6 weeks, after 6 month and after one year
|
measured by Hospital Anxiety and Depression Scale (HAD)
|
at baseline, after 6 weeks, after 6 month and after one year
|
Quality of life
Periodo de tiempo: at baseline, after 6 weeks, after 6 month and after one year
|
measured by The Minnesota Living with Heart Failure Questionnaire
|
at baseline, after 6 weeks, after 6 month and after one year
|
Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)
Periodo de tiempo: at 6 weeks, after 6 month and after one year
|
at 6 weeks, after 6 month and after one year
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- H-2-2012-021
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. .
Ensayos clínicos sobre Insuficiencia cardíaca crónica
-
Region SkaneInscripción por invitaciónInsuficiencia cardíaca New York Heart Association (NYHA) Clase II | Insuficiencia cardíaca New York Heart Association (NYHA) Clase IIISuecia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... y otros colaboradoresAún no reclutandoInsuficiencia Cardíaca Sistólica | Insuficiencia cardíaca con fracción de eyección reducida | Insuficiencia cardíaca Clase IV de la New York Heart Association | Insuficiencia cardíaca Clase III de la New York Heart AssociationPolonia
-
Novartis PharmaceuticalsTerminadoPacientes que completaron con éxito el período de tratamiento de 12 meses del estudio principal (receptores de Novo Heart) que estaban interesados en recibir tratamiento con EC-MPS
-
University of WashingtonAmerican Heart AssociationTerminadoInsuficiencia cardíaca, congestiva | Alteración mitocondrial | Insuficiencia cardíaca Clase IV de la New York Heart AssociationEstados Unidos