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El ensayo clínico NCT07492745 (REMOTIVE) para Pacientes hospitalizados, Frágil está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay. (REMOTIVE) 204 Ejercicio
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07492745 (REMOTIVE) es un estudio intervencionista para Pacientes hospitalizados, Frágil. Su estado actual es: reclutando. El estudio se inició el 19 de noviembre de 2025, con el objetivo de reclutar a 204 participantes. Dirigido por Groupe Hospitalier du Havre, se espera que finalice el 1 de enero de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
Around 30% of patients aged 65 and over experience functional decline due to hospitalization. Physical inactivity, often without medical justification, is common during hospital stays.This immobility leads to loss of autonomy, muscle strength, and increases post-discharge risks.
Slow walking for 25-40 minutes daily significantly improves functional capacity. However, it could be difficult to reach this time of walki...
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30% of patients aged 65 or older will experience a decline in functional capacity as a result of hospitalization.
Illness and hospitalization increase sedentary behavior in patients. It is common for patients to spend long periods of time resting in bed, regardless of their primary reason for admission. During hospitalization, nearly 60% of episodes of bed rest have no documented medical indications. Low physical ac...
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Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay : a Multicenter Randomised Controlled Double Blind Study.
Condiciones médicas
Pacientes hospitalizadosFrágilOtros ID del estudio
- REMOTIVE
- 25.01855.000458
- PHRIP-23-0006 (Otra financiación) (DGOS)
Número del NCT
Inicio del estudio (real)
2025-11-19
Última actualización
2026-03-25
Fecha de finalización (estimada)
2029-01-01
Inscripción (prevista)
204
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
inpatients
physical activity
reminder device
frailty
functional independancy
physical activity
reminder device
frailty
functional independancy
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Triple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalIntervention Regardless of randomization, the physiotherapist will be able to provide the patient with the usual care, such as walking, muscle strengthening exercises, and respiratory physiotherapy if necessary. Self-rehabilitation exercises will be given to the patient, who will have to perform them independently. The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibr...Mostrar más | Vibrating reminder The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off six times a day. |
Comparador simuladocontrol In the control group, the physiotherapist will perform the usual treatments and apply the protocol described above in the experimental group, but will set the vibrating watch, to go off once a day. The patient will be advised to perform the exercises every hour independantly. | GRUPO DE CONTROL The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off once time a day. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
SPPB | The SPPB (Short Physical Performance Battery) is the sum of scores on three criteria: the balance test, the walking speed test, and the chair rise test. This test assesses an individual's physical performance. The score ranges from 0 (lowest) to 12 (highest). The magnitude of change considered clinically relevant for the SPPB is 1 point. | Within 24 hours of admission and within 48 hours prior to discharge from hospital. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Volume and intensity of physical activity | The number of steps per day and the number of movements per minute will be measured.An accelerometer will be placed on the wrist of the non-dominant limb. Data will be measured 24 hours a day. | Within 24 hours of admission and within 48 hours prior to discharge from hospital. |
functional independancy | Will be measured using the Barthel Index, based on the patient's level of independancy during the week prior to hospitalization and upon discharge from the hospital. The Barthel Index assesses a person's ability to perform ten essential activities of daily living. | Within 24 hours of admission and within 48 hours prior to discharge from hospital. |
Patient compliance to the prescribed exercises | Compliance will be measured using a compliance record sheet. This will enable us to note whether the exercises have been performed, and if so, the number of times per day, the schedule, the type, the reason for interruption, and whether or not there has been any pain, rated from 0 to 10. | Within 24 hours of baseline and within 48 hours prior to discharge from hospital |
falls | number of falls during hospitalization | Within 24 hours of baseline and within 48 hours prior to discharge from hospital ; and at 3 months after discharge. |
Volume and type of rehabilitation in-hospital | performed by physiotherapist | Within 24 hours of baseline and within 48 hours prior to discharge from hospital |
The volume and location of rehabilitation | performed by rehabilitation professionals after discharge | at 3 months after discharge |
Health-related Quality of life | mesured by EuroQol(5-5). It assesses quality of life according to five main dimensions: mobility, independence, daily activities, pain and discomfort, anxiety, and depression. Each dimension is assessed on a five-point severity scale. The score ranges from 0 to 100 (best possible health) | 24 hours after admission, 48 hours before discharge, and 3 months after hospitalization |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
50 Years
Criterios de sexo
Todos
- Patients aged 50 or over with a score of 4 or above on the Clinical Frailty Scale (vulnerable but not dependent patients, symptoms limiting activities, patients who are slower/more fatigued).
- Must be able to get up from a chair without assistance.
- Patients must be able to communicate with staff, understand instructions, give consent, and cooperate with staff.
- Patients with an estimated hospital stay of less than 5 days.
- Contraindications to physical activity determined by the medical team (e.g., cardiovascular instability, orthopedic contraindications, etc.).
- Terminal illness.
- Patients scheduled for surgery.
- Pregnant women.
- People who do not understand French.
- People protected under the law.
Groupe Hospitalier du Havre- Centre Hospitalier de Valence
- Centre Hospitalier of Chartres
Contactos centrales del estudio
Contacto: Guillaume Prieur, PT, PhD, +33630038824, [email protected]
Contacto: Yann Combret, PT, PhD, +33686327255, [email protected]
3 Centros del estudio en 1 países
Normandy
Groupe Hospitalier du Havre, Le Havre, Normandy, 76290, France
Guillaume Prieur, Investigador principal
Reclutando
Centre hospitalier de Chartres, Le Coudray, 28630, France
Gaëtan BADRE, Infirmier recherche clinique, Contacto, 0237303030, [email protected]
Aún no recluta
centre hospitalier de Valence, Valence, 26000, France
Baptiste Fontanille, MKDE, Contacto, [email protected]
Aún no recluta