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A Multicomponent Physical Activity Intervention for Older Adults

A Multicomponent Physical Activity Intervention for Older Adults: the ActiveKIT Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07729007
Acronym
ActiveKIT
Enrollment
201
Registered
2026-07-27
Start date
2023-03-06
Completion date
2025-03-14
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fitness, Inactive People, Older Adults (65 Years and Older), Physical Activity

Brief summary

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.

Interventions

BEHAVIORALExercise toolkit

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

BEHAVIORALExercise toolkit plus specialist support

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.

Sponsors

Universidad Autonoma de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Change in 30-Second Chair Stand TestBaseline, 3 months and 12 months
Change in hand grip strengthBaseline, 3 months and 12 months

Secondary

MeasureTime frameDescription
Change in 2-Minute Step TestBaseline, 3 months and 12 months
Change in Timed Up and Go testBaseline, 3 months and 12 months
Change in Back Scratch TestBaseline, 3 months and 12 months
Change in Chair Sit-and-Reach TestBaseline, 3 months and 12 months
Change in the International Fitness ScaleBaseline, 3 months and 12 monthsPerceived overall and fitness components using a five-point Likert response scale ranging from 1 to 5 (very poor, poor, average, good, and very good)
Change in the IMPaCT physical activity and sedentary behavior questionnaireBaseline, 3 months and 12 monthsIntensity, duration, type and context of PA (leisure, transport, occupational, domestic)
Change in wrist-worn accelerometer behaviorsBaseline, 3 months and 12 monthsMinutes in moderate-to vigorous physical activity, light-intensity physical activity, and sedentary time
Change in wrist-worn accelerometer activityBaseline, 3 months and 12 monthsTotal movement (mg)
Change in wrist-worn step patternsBaseline, 3 months and 12 monthsDaily steps and cadence

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026