A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)
22 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
201
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Madrid, Spanje
- Universidad Autonoma de Madrid
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: 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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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Change in 30-Second Chair Stand Test
Tijdsspanne: 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
Tijdsspanne: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in 2-Minute Step Test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in adherence to the Mediterranean diet
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in blood pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and 3 months
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Baseline and 3 months
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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 maart 2023
Primaire voltooiing (Werkelijk)
14 maart 2025
Studie voltooiing (Werkelijk)
14 maart 2025
Studieregistratiedata
Eerst ingediend
20 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 juli 2026
Eerst geplaatst (Werkelijk)
27 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
22 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PI20/00657
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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