- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07823166
Comparison of the Effects of Motor and Cognitive Dual Task Exercises on Fall Risk, Balance, and Gait
Comparison of the Effects of Motor and Cognitive Dual Task Exercises on Fall Risk, Balance, and Gait in Geriatric Individuals Residing in Nursing Homes: A Randomized Controlled Trial
This study aimed to compare the effects of motor and cognitive dual-task exercise programs on fall risk, balance, and gait performance in older adults residing in nursing homes.The main question it aims to answer is:
An eight-week motor or cognitive dual-task exercise program did not provide additional benefits over standard single-task exercise in improving fall risk, balance, or gait performance in nursing home residents.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
Assessments were conducted before and after the intervention using the Five-Repetition Sit-to-Stand Test, 2-Minute Walk Test, Single-Leg Stance Test, Timed Up and Go (TUG) Test, Tinetti Balance and Gait Scale, and Functional Reach Test.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Individuals residing in nursing homes who were aged between 65 and 95 years, able to walk independently, literate, willing to participate, and cognitively capable of understanding and performing the assessments and exercises were included in the study.
Individuals with systemic or metabolic conditions such as malignancy, osteoporosis, history of fracture, coagulation disorders, active infection, orthostatic hypotension, or pacemaker implantation were excluded. Participants were withdrawn from the study if they discontinued the intervention, failed to attend pre- or post-intervention assessments, or were unable to understand or perform the required tests and exercises.
A total of 69 eligible participants were allocated into three groups using a systematic allocation sequence based on the order of enrollment. Participants were assigned sequentially to the motor dual-task group, cognitive dual-task group, or control group in a 1:1:1 ratio.
Due to the absence of a dedicated exercise room, all interventions were conducted in participants' rooms using space-adapted exercise protocols.
Participants in the motor dual-task group performed a structured exercise program consisting of the Five Times Sit-to-Stand Test, Timed Up and Go test (3 m), single-leg stance, 10-meter tandem walking, 10-meter normal walking, and a 20-meter marching activity while simultaneously carrying a tray filled with water.
Participants in the cognitive dual-task group performed the same exercise program combined with a concurrent cognitive task. During each exercise, participants were instructed to verbally generate proper nouns beginning with the letter "A".
The control group performed a conventional exercise program of equivalent duration and frequency without any additional dual-task component.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
Baseline demographic characteristics, including participant identification number, group allocation, age, sex, body weight, and height, were recorded using a standardized assessment form. All evaluations were performed before and after the eight-week intervention period by the same physiotherapist to ensure assessment consistency and minimize inter-rater variability.
Fall risk was assessed using the Five Times Sit-to-Stand Test (FTSST). Balance and gait performance were evaluated using the 2-Minute Walk Test (2MWT), Single-Leg Stance Test, Timed Up and Go (TUG) Test, Tinetti Balance and Gait Assessment Scale, and Functional Reach Test.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
ÇANKAYA
-
Ankara, ÇANKAYA, Turquía (Türkiye), 06550
- Altınçatı Nursing Home and Elderly Care Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- residing in nursing homes who were aged between 65 and 95 years
- Individuals able to walk independently
- Individuals who are literate
- Individuals willing to participate in the study
- Individuals cognitively capable of understanding and performing the required assessments and exercises.
Exclusion Criteria:
- Individuals with malignancy
- Individuals with osteoporosis
- Individuals with a history of fracture
- Individuals with coagulation disorders
- Individuals with an active infection
- Individuals with orthostatic hypotension
- Individuals with pacemaker implantation
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 |
|---|---|
|
Comparador activo: Grupo de control
|
The control group performed a conventional exercise program of equivalent duration and frequency without any additional dual-task component.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
|
|
Experimental: Motor Dual-Task Exercise Group
|
Participants in the motor dual-task group performed a structured exercise program consisting of the Five Times Sit-to-Stand Test, Timed Up and Go test (3 m), single-leg stance, 10-meter tandem walking, 10-meter normal walking, and a 20-meter marching activity while simultaneously carrying a tray filled with water.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
|
|
Experimental: Cognitive Dual-Task Exercise Group
|
Participants in the cognitive dual-task group performed the same exercise program combined with a concurrent cognitive task.
During each exercise, participants were instructed to verbally generate proper nouns beginning with the letter "A".
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
2-Minute Walk Test (2MWT)
Periodo de tiempo: 8 weeks
|
Walking capacity was assessed over a 30-meter walkway during a two-minute period.
Participants wore comfortable clothing and footwear and rested for 10 minutes before testing.
The total walking distance was recorded in meters.
|
8 weeks
|
|
Five Times Sit-to-Stand Test (FTSST)
Periodo de tiempo: 8 weeks
|
The FTSST was used to assess lower extremity strength, functional mobility, and fall risk.
Participants were instructed to stand up from a standard chair and sit down five consecutive times as quickly as possible while keeping their arms crossed over the chest.
Total completion time was recorded using a stopwatch.
|
8 weeks
|
|
Timed Up and Go (TUG) Test
Periodo de tiempo: 8 weeks
|
Functional mobility was assessed by measuring the time required for participants to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down.
Time was recorded in seconds using a stopwatch.
|
8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Single-Leg Stance Test
Periodo de tiempo: 8 weeks
|
Static balance was evaluated by asking participants to stand on one leg while lifting the opposite foot approximately 5 cm off the ground.
Participants were instructed to maintain balance for as long as possible, and the duration was recorded using a stopwatch.
|
8 weeks
|
|
Tinetti Balance and Gait Assessment Scale
Periodo de tiempo: 8 weeks
|
Balance and gait performance were assessed using the Tinetti Balance and Gait Assessment Scale according to standardized administration procedures.
Total scores were used to classify fall risk.
|
8 weeks
|
|
Functional Reach Test
Periodo de tiempo: 8 weeks
|
Dynamic balance was assessed using the Functional Reach Test.
A measuring tape was positioned horizontally on the wall at shoulder height.
Participants were instructed to reach forward as far as possible with the dominant arm elevated to 90° shoulder flexion without stepping or losing balance.
The distance between the initial and maximal reach positions was recorded in centimeters.
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: BİHTER AKINOĞLU, Assoc. Prof. Dr., PT., Ankara Yildirim Beyazıt University
Fechas de registro del estudio
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AYBU-FTR-BA-11
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .