Older Adults (65 Years and Older)ActiveKITNCT07729007
A Multicomponent Physical Activity Intervention for Older Adults
A study testing Exercise toolkit and Exercise toolkit plus specialist support in people with Older Adults (65 Years and Older) and Inactive People, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults (65 Years and Older), Inactive People, Fitness
- What is being tested?
- Exercise toolkit and Exercise toolkit plus specialist support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2023to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Exercise toolkit, Exercise toolkit plus specialist support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise toolkitBehavioural
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
Exercise toolkit plus specialist supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function. |
| Exercise toolkit | Experimental | A low-cost, easy-to-use, home-based exercise toolkit designed to promote multicomponent physical activity and improve physical function. Receives: Behavioral: Exercise toolkit |
| Exercise toolkit plus specialist support | Experimental | 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). Receives: Behavioral: Exercise toolkit plus specialist support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30-Second Chair Stand Test
Measured: Baseline, 3 months and 12 months
Change in hand grip strength
Measured: Baseline, 3 months and 12 months
Secondary outcomes (9)
Change in 2-Minute Step Test
Measured: Baseline, 3 months and 12 months
Change in Timed Up and Go test
Measured: Baseline, 3 months and 12 months
Change in Back Scratch Test
Measured: Baseline, 3 months and 12 months
Change in Chair Sit-and-Reach Test
Measured: Baseline, 3 months and 12 months
Change in the International Fitness Scale
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)
Measured: Baseline, 3 months and 12 months
Change in the IMPaCT physical activity and sedentary behavior questionnaire
Intensity, duration, type and context of PA (leisure, transport, occupational, domestic)
Measured: Baseline, 3 months and 12 months
Change in wrist-worn accelerometer behaviors
Minutes in moderate-to vigorous physical activity, light-intensity physical activity, and sedentary time
Measured: Baseline, 3 months and 12 months
Change in wrist-worn accelerometer activity
Total movement (mg)
Measured: Baseline, 3 months and 12 months
Change in wrist-worn step patterns
Daily steps and cadence
Measured: Baseline, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start6 Mar 2023
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Martinez Gomez, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729007
- Sponsor's protocol ID
- PI20/00657
- Acronym
- ActiveKIT
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicomponent Physical Activity Intervention for Older Adults: the ActiveKIT Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07729007
- Acronym / sponsor ID
- ActiveKIT / PI20/00657
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function. |
| Exercise toolkit | Experimental | Behavioral: Exercise toolkitA low-cost, easy-to-use, home-based exercise toolkit designed to promote multicomponent physical activity and improve physical function. |
| Exercise toolkit plus specialist support | Experimental | Behavioral: Exercise toolkit plus specialist supportThe 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- Participants were excluded if they met any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise toolkitAt 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 | Behavioural | Exercise toolkit |
| Exercise toolkit plus specialist supportIn 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. | Behavioural | Exercise toolkit plus specialist support |
Primary outcome
Change in 30-Second Chair Stand Test
Time frame: Baseline, 3 months and 12 months
Change in hand grip strength
Time frame: Baseline, 3 months and 12 months
9 secondary outcomes
Change in 2-Minute Step Test
Time frame: Baseline, 3 months and 12 months
Change in Timed Up and Go test
Time frame: Baseline, 3 months and 12 months
Change in Back Scratch Test
Time frame: Baseline, 3 months and 12 months
Change in Chair Sit-and-Reach Test
Time frame: Baseline, 3 months and 12 months
Change in the International Fitness Scale
Time frame: Baseline, 3 months and 12 months
Change in the IMPaCT physical activity and sedentary behavior questionnaire
Time frame: Baseline, 3 months and 12 months
Change in wrist-worn accelerometer behaviors
Time frame: Baseline, 3 months and 12 months
Change in wrist-worn accelerometer activity
Time frame: Baseline, 3 months and 12 months
Change in wrist-worn step patterns
Time frame: Baseline, 3 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise toolkit and Exercise toolkit plus specialist support in people with Older Adults (65 Years and Older) and Inactive People, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30-Second Chair Stand Test (time frame: Baseline, 3 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.