EFFECT OF A PHYSICAL EXERCISE PROGRAM ON FUNCTIONAL CAPACITY AND FALL PREVENTION IN PSYCHIATRIC INPATIENT CARE
14 de septiembre de 2026 actualizado por: Hospital de Clinicas de Porto Alegre
EFFECT OF A PHYSICAL EXERCISE PROGRAM ON FUNCTIONAL CAPACITY AND FALL PREVENTION IN PSYCHIATRIC INPATIENT CARE: A RANDOMIZED CLINICAL TRIAL
Falls are an important health problem, especially among adults and older people who are hospitalized, because they can cause injuries, increase the length of hospital stay, and make it more difficult to perform daily activities. In psychiatric inpatient units, the risk of falls may be higher due to medication use, changes in attention and thinking, balance difficulties, reduced muscle strength, and lower awareness of the risk of falling.
This study aims to evaluate whether a physical exercise program can help patients hospitalized in a psychiatric unit improve their ability to perform movements and daily activities and reduce their risk of falls. The study will include 46 adult and older patients of both sexes who have a moderate or high risk of falls.
Participants will be randomly divided into two groups. One group will continue with the physical activities that are normally part of the unit's routine. The other group will participate in an organized exercise program, including aerobic exercises, muscle-strengthening exercises, and balance exercises. The exercises will be performed two to three times per week, for at least six sessions.
Before and after the program, assessments will be carried out to evaluate the participants' physical ability and risk of falls. It is expected that the exercises will help patients improve their physical performance and contribute to preventing falls during hospitalization.
Descripción general del estudio
Descripción detallada
Falls represent an important public health problem, especially among hospitalized adult and older patients, due to the risk of injuries, increased length of hospital stay, loss of functional capacity, and worsening of the clinical condition.
In psychiatric inpatient units (PIUs), this risk becomes even more relevant due to factors such as the use of psychotropic medications, cognitive impairments, balance deficits, reduced muscle strength, and low risk perception.
Although the benefits of physical exercise on functional capacity are widely described in the literature, studies investigating its direct relationship with fall prevention in hospitalized psychiatric patients are still scarce.
In this context, the present study aims to develop and implement a physical exercise program for patients hospitalized in a PIU, evaluating its effects on functional capacity and fall risk.
This is a randomized controlled clinical trial, with two arms (control group and intervention group), to be conducted in a PIU of a large hospital in the southern region of Brazil.
The sample will consist of 46 adult and older patients of both sexes, classified as having moderate or high risk of falls, according to the SAKp Fall Risk Scale.
Participants will be randomized into blocks of six individuals.
The control group will follow the unit's usual physical exercise routine, while the intervention group will participate in a systematized program of aerobic, resistance, and balance exercises, performed two to three times per week, totaling at least six sessions.
Assessments will be performed before and after the intervention using the Short Physical Performance Battery (SPPB) and Calf Circumference (CC).
The primary outcome will be improvement in functional capacity and, as a secondary outcome, reduction in fall risk.
It is expected that the intervention will contribute to improving the functional performance of hospitalized patients, assisting in fall prevention.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
46
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
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 90410-000
- Hospital de Clinicas de Porto Alegre
-
-
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:
- Patients hospitalized in a Psychiatric Inpatient Unit;
- Adults aged 18 years or older;
- SAKp Fall Risk Scale with a moderate risk score (6.5 to 10 points) or high risk (10.5 points or higher);
- Clinical and cognitive conditions that allow the performance of physical exercises;
- Patients with an expected hospital stay of 12 days or longer, in order to ensure minimum exposure to the proposed intervention;
- Agreement to participate in the study by signing the Informed Consent Form.
Exclusion Criteria:
- Patients with medical restrictions on the practice of physical exercise will be excluded from the study;
- Patients with an acute or unstable clinical condition that prevents the performance of the assessments;
- Patients or their legal representative who do not agree to participate or who withdraw from the study at any stage.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Intervention Group
The intervention group will undergo a systematized physical training program two to three times per week, totaling at least six sessions throughout the hospitalization period, with a duration of 20 to 30 minutes per session.
|
The program will be carried out in the unit's gym and will include aerobic, resistance, and balance exercises.
Sessions will begin with 5 to 10 minutes of aerobic exercise on a cycle ergometer, followed by step-up and step-down exercises, lateral stepping, standing hip flexion with ankle weights, squats, and single-leg balance on a balance disc.
The exercises will be performed in two sets of 10 repetitions, except for single-leg balance, which will be performed in two 20-second sets.
Exercise execution and progression will be adapted to each patient's clinical and functional conditions.
|
|
Sin intervención: Control Group
The control group will follow the existing physical activity routine.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional capacity
Periodo de tiempo: 15 days
|
The primary outcome is an improvement in functional capacity, assessed using the Short Physical Performance Battery (SPPB).
The instrument evaluates three components: balance, lower-limb strength, and gait performance.
The total score ranges from 0 to 12 points and is classified as follows: 0-3 points: disability; 4-6 points: low physical performance; 7-9 points: moderate physical performance; and 10-12 points: good physical performance.
|
15 days
|
|
Calf Circumference
Periodo de tiempo: 15 days
|
Calf circumference is used to assess muscle mass and predict physical and functional impairments.
The cutoff point for this measurement ranges from 31-35 cm in women and 33-34 cm in men.
The measurement is performed with the patient seated, at the largest circumference of the calf, with the leg positioned at a 90° angle.
|
15 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fall Risk Score
Periodo de tiempo: 15 days
|
Fall risk will be measured using the Severo-Almeida-Kuchembecker (SAK) Fall Risk Scale, which comprises seven variables: disorientation/confusion, frequent urination, gait impairment, absence of a companion, postoperative status and/or undergoing electroconvulsive therapy (ECT), number of medications administered within 24 hours, and history of falls.
The scoring ranges are: 0-6, low fall risk; 6.5-10, moderate risk; and ≥10.5, high risk.
The SAK will be administered immediately after the patient is accepted into the study and again right after the six sessions of the exercise program.
|
15 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Paolo P Lamb, Hospital de Clinicas de Porto Alegre
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 (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
15 de diciembre de 2026
Finalización del estudio (Estimado)
20 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0204
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. .