A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)
22 de julio de 2026 actualizado por: David Martinez Gomez, Universidad Autonoma de Madrid
A Multicomponent Physical Activity Intervention for Older Adults: the ActiveKIT Randomized Controlled Trial
ActiveKIT is a three-arm, parallel-group, individually randomized controlled trial.
Community-dwelling adults aged 65 years or older (n=201) from Madrid and surrounding municipalities who were inactive were randomized into tree arms: a low-cost home-based exercise toolkit, the same toolkit plus remote specialist support, or usual-care.
The intervention lasted 12 weeks, with assessments at baseline, 3 months, and 12 months.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
201
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
-
-
-
Madrid, España
- Universidad Autonoma de Madrid
-
-
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 Mayor
Acepta Voluntarios Saludables
Sí
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
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 |
|---|---|
|
Sin intervención: Usual care
Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function.
|
|
|
Experimental: Exercise toolkit
A low-cost, easy-to-use, home-based exercise toolkit designed to promote multicomponent physical activity and improve physical function.
|
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
|
|
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).
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in 30-Second Chair Stand Test
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
Change in hand grip strength
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in 2-Minute Step Test
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Timed Up and Go test
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Back Scratch Test
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Chair Sit-and-Reach Test
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in the International Fitness Scale
Periodo de tiempo: Baseline, 3 months and 12 months
|
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)
|
Baseline, 3 months and 12 months
|
|
Change in the IMPaCT physical activity and sedentary behavior questionnaire
Periodo de tiempo: Baseline, 3 months and 12 months
|
Intensity, duration, type and context of PA (leisure, transport, occupational, domestic)
|
Baseline, 3 months and 12 months
|
|
Change in wrist-worn accelerometer behaviors
Periodo de tiempo: Baseline, 3 months and 12 months
|
Minutes in moderate-to vigorous physical activity, light-intensity physical activity, and sedentary time
|
Baseline, 3 months and 12 months
|
|
Change in wrist-worn accelerometer activity
Periodo de tiempo: Baseline, 3 months and 12 months
|
Total movement (mg)
|
Baseline, 3 months and 12 months
|
|
Change in wrist-worn step patterns
Periodo de tiempo: Baseline, 3 months and 12 months
|
Daily steps and cadence
|
Baseline, 3 months and 12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in adherence to the Mediterranean diet
Periodo de tiempo: Baseline, 3 months and 12 months
|
14-item Mediterranean Diet Adherence Screener, Score 0-14, higher = better adherence.
|
Baseline, 3 months and 12 months
|
|
Change in sleep duration
Periodo de tiempo: Baseline, 3 months and 12 months
|
Average night and nap duration
|
Baseline, 3 months and 12 months
|
|
Daytime sleepiness
Periodo de tiempo: Baseline, 3 months and 12 months
|
Epworth Sleepiness Scale, Spanish version
|
Baseline, 3 months and 12 months
|
|
Change in Health-related quality of life
Periodo de tiempo: Baseline, 3 months and 12 months
|
EuroQol EQ-5D-3L
|
Baseline, 3 months and 12 months
|
|
Change in depressive symptoms
Periodo de tiempo: Baseline, 3 months and 12 months
|
10-item Geriatric Depression Scale
|
Baseline, 3 months and 12 months
|
|
Change in self-efficacy
Periodo de tiempo: Baseline, 3 months and 12 months
|
Spanish General Self-Efficacy Scale; 10 items, 4-point Likert, higher = greater
|
Baseline, 3 months and 12 months
|
|
Change in physical activity enjoyment
Periodo de tiempo: Baseline, 3 months and 12 months
|
Single-item score ranging from 1 to 10; higher scores indicate greater enjoyment.
|
Baseline, 3 months and 12 months
|
|
Change in body mass index
Periodo de tiempo: Baseline, 3 months and 12 months
|
Derived from height and weight in kg/m2
|
Baseline, 3 months and 12 months
|
|
Change in waist circumference
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in blood pressure
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in resting heart rate
Periodo de tiempo: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Safety during and after the intervention
Periodo de tiempo: 3 months and 12 months
|
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.
|
3 months and 12 months
|
|
Economic costs of the intervention
Periodo de tiempo: Baseline and 3 months
|
Baseline and 3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
6 de marzo de 2023
Finalización primaria (Actual)
14 de marzo de 2025
Finalización del estudio (Actual)
14 de marzo de 2025
Fechas de registro del estudio
Enviado por primera vez
20 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2026
Publicado por primera vez (Actual)
27 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PI20/00657
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. .