A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)
22 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
201
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Madrid, Espagne
- Universidad Autonoma de Madrid
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Change in 30-Second Chair Stand Test
Délai: 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
Délai: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in 2-Minute Step Test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in adherence to the Mediterranean diet
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in blood pressure
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 3 months
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Baseline and 3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 mars 2023
Achèvement primaire (Réel)
14 mars 2025
Achèvement de l'étude (Réel)
14 mars 2025
Dates d'inscription aux études
Première soumission
20 juillet 2026
Première soumission répondant aux critères de contrôle qualité
22 juillet 2026
Première publication (Réel)
27 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PI20/00657
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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