A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)
22 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
201
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Madrid, Spanien
- Universidad Autonoma de Madrid
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: 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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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change in 30-Second Chair Stand Test
Tidsram: 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
Tidsram: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in 2-Minute Step Test
Tidsram: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
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Change in Timed Up and Go test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in adherence to the Mediterranean diet
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and 3 months
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Baseline and 3 months
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
6 mars 2023
Primärt slutförande (Faktisk)
14 mars 2025
Avslutad studie (Faktisk)
14 mars 2025
Studieregistreringsdatum
Först inskickad
20 juli 2026
Först inskickad som uppfyllde QC-kriterierna
22 juli 2026
Första postat (Faktisk)
27 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PI20/00657
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