A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)
A Multicomponent Physical Activity Intervention for Older Adults: the ActiveKIT Randomized Controlled Trial
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid, España
- Universidad Autonoma de Madrid
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participants were eligible if they were aged 65 years or older and able to undertake physical activity safely, with no contraindications to increasing their physical activity level
Exclusion Criteria:
Participants were excluded if they met any of the following criteria:
- Institutionalized or housebound;
- Three or more falls, or one or more falls requiring medical attention, in the previous year;
- Terminal illness;
- Cognitive impairment precluding the ability to follow simple instructions;
- Blindness;
- New onset within the previous three months of conditions such as chest pain, myocardial infarction, coronary artery bypass graft, or angioplasty;
- Chronic or acute conditions that contraindicated increased physical activity, such as pneumonia, acute rheumatoid arthritis, unstable or acute heart failure, significant neurological disease or impairment, inability to move about independently, or severe psychiatric disorders;
- Already physically active, defined as self-reported attainment of any of the three public health physical activity recommendations for older adults (aerobic activity, muscle-strengthening activity, or balance training), because the intervention was specifically designed for inactive older adults.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Sin intervención: Usual care
Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function.
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Experimental: Exercise toolkit
A low-cost, easy-to-use, home-based exercise toolkit designed to promote multicomponent physical activity and improve physical function.
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At the start of the intervention, participants received a home-delivered toolkit and a printed exercise guide.
The toolkit included a smartwatch to monitor daily physical activity, color-coded resistance bands, an exercise mat, a gymnastic stick, cones, and a light dumbbell to support aerobic, strength, balance, coordination, flexibility, and mobility training.
The guide provided a structured 12-week progressive multicomponent program covering the four physical activity domains recommended for older adults: aerobic exercise, muscle strengthening, balance/coordination, and flexibility.
Training volume and difficulty increased weekly, with walking progressing from 15 to 55 minutes per session and strength and balance exercises from 8 to 12 repetitions per set.
Standing, seated, and supported exercise options were included to accommodate different functional capacities and promote safe progression toward WHO physical activity recommendations
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Experimental: Exercise toolkit plus specialist support
The same exercise toolkit supplemented with remote support from an exercise specialist delivered through virtual channels (for example, video or audio calls, messaging applications, and social networks).
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In addition to the exercise toolkit, participants allocated to Arm 2 received remote support from an exercise specialist with training in physical activity promotion and behavior-change techniques.
Support focused on goal setting, identification of barriers and facilitators, problem solving, progression of activities, motivation, and safety.
Participants selected their preferred communication channel, including telephone calls, video calls, messaging applications, or social media platforms.
Each participant received two scheduled 15-minute contacts per week throughout the intervention, with a maximum of two additional contacts available upon request when additional support was needed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in 30-Second Chair Stand Test
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in hand grip strength
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in 2-Minute Step Test
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in Timed Up and Go test
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in Back Scratch Test
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in Chair Sit-and-Reach Test
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in the International Fitness Scale
Periodo de tiempo: Baseline, 3 months and 12 months
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Perceived overall and fitness components using a five-point Likert response scale ranging from 1 to 5 (very poor, poor, average, good, and very good)
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Baseline, 3 months and 12 months
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Change in the IMPaCT physical activity and sedentary behavior questionnaire
Periodo de tiempo: Baseline, 3 months and 12 months
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Intensity, duration, type and context of PA (leisure, transport, occupational, domestic)
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Baseline, 3 months and 12 months
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Change in wrist-worn accelerometer behaviors
Periodo de tiempo: Baseline, 3 months and 12 months
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Minutes in moderate-to vigorous physical activity, light-intensity physical activity, and sedentary time
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Baseline, 3 months and 12 months
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Change in wrist-worn accelerometer activity
Periodo de tiempo: Baseline, 3 months and 12 months
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Total movement (mg)
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Baseline, 3 months and 12 months
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Change in wrist-worn step patterns
Periodo de tiempo: Baseline, 3 months and 12 months
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Daily steps and cadence
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Baseline, 3 months and 12 months
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Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in adherence to the Mediterranean diet
Periodo de tiempo: Baseline, 3 months and 12 months
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14-item Mediterranean Diet Adherence Screener, Score 0-14, higher = better adherence.
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Baseline, 3 months and 12 months
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Change in sleep duration
Periodo de tiempo: Baseline, 3 months and 12 months
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Average night and nap duration
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Baseline, 3 months and 12 months
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Daytime sleepiness
Periodo de tiempo: Baseline, 3 months and 12 months
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Epworth Sleepiness Scale, Spanish version
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Baseline, 3 months and 12 months
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Change in Health-related quality of life
Periodo de tiempo: Baseline, 3 months and 12 months
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EuroQol EQ-5D-3L
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Baseline, 3 months and 12 months
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Change in depressive symptoms
Periodo de tiempo: Baseline, 3 months and 12 months
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10-item Geriatric Depression Scale
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Baseline, 3 months and 12 months
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Change in self-efficacy
Periodo de tiempo: Baseline, 3 months and 12 months
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Spanish General Self-Efficacy Scale; 10 items, 4-point Likert, higher = greater
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Baseline, 3 months and 12 months
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Change in physical activity enjoyment
Periodo de tiempo: Baseline, 3 months and 12 months
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Single-item score ranging from 1 to 10; higher scores indicate greater enjoyment.
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Baseline, 3 months and 12 months
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Change in body mass index
Periodo de tiempo: Baseline, 3 months and 12 months
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Derived from height and weight in kg/m2
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Baseline, 3 months and 12 months
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Change in waist circumference
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in blood pressure
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in resting heart rate
Periodo de tiempo: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Safety during and after the intervention
Periodo de tiempo: 3 months and 12 months
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Adverse events (frequency) were also systematically assessed at the 3- and 12-month follow-up visits and included falls, injuries, exacerbations of pre-existing conditions, major cardiovascular events, hospitalizations, and deaths.
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3 months and 12 months
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Economic costs of the intervention
Periodo de tiempo: Baseline and 3 months
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Baseline and 3 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- PI20/00657
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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