A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)
22. juli 2026 oppdatert 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
201
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Madrid, Spania
- Universidad Autonoma de Madrid
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Usual care
Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function.
|
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in 30-Second Chair Stand Test
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
Change in hand grip strength
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in 2-Minute Step Test
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Timed Up and Go test
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Back Scratch Test
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Chair Sit-and-Reach Test
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in the International Fitness Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 3 months and 12 months
|
Total movement (mg)
|
Baseline, 3 months and 12 months
|
|
Change in wrist-worn step patterns
Tidsramme: Baseline, 3 months and 12 months
|
Daily steps and cadence
|
Baseline, 3 months and 12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in adherence to the Mediterranean diet
Tidsramme: 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
Tidsramme: Baseline, 3 months and 12 months
|
Average night and nap duration
|
Baseline, 3 months and 12 months
|
|
Daytime sleepiness
Tidsramme: Baseline, 3 months and 12 months
|
Epworth Sleepiness Scale, Spanish version
|
Baseline, 3 months and 12 months
|
|
Change in Health-related quality of life
Tidsramme: Baseline, 3 months and 12 months
|
EuroQol EQ-5D-3L
|
Baseline, 3 months and 12 months
|
|
Change in depressive symptoms
Tidsramme: Baseline, 3 months and 12 months
|
10-item Geriatric Depression Scale
|
Baseline, 3 months and 12 months
|
|
Change in self-efficacy
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 3 months and 12 months
|
Derived from height and weight in kg/m2
|
Baseline, 3 months and 12 months
|
|
Change in waist circumference
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in blood pressure
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in resting heart rate
Tidsramme: Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Safety during and after the intervention
Tidsramme: 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
Tidsramme: Baseline and 3 months
|
Baseline and 3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. mars 2023
Primær fullføring (Faktiske)
14. mars 2025
Studiet fullført (Faktiske)
14. mars 2025
Datoer for studieregistrering
Først innsendt
20. juli 2026
Først innsendt som oppfylte QC-kriteriene
22. juli 2026
Først lagt ut (Faktiske)
27. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PI20/00657
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .