A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)

July 22, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Universidad Autonoma de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual care
Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function.
Experimental: Exercise toolkit
A low-cost, easy-to-use, home-based exercise toolkit designed to promote multicomponent physical activity and improve physical function.
Behavioral: Exercise 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
Experimental: 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).
Behavioral: Exercise 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in 30-Second Chair Stand Test
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Change in hand grip strength
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in 2-Minute Step Test
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Change in Timed Up and Go test
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Change in Back Scratch Test
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Change in Chair Sit-and-Reach Test
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Change in the International Fitness Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 3 months and 12 months
Total movement (mg)
Baseline, 3 months and 12 months
Change in wrist-worn step patterns
Time Frame: Baseline, 3 months and 12 months
Daily steps and cadence
Baseline, 3 months and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in adherence to the Mediterranean diet
Time Frame: 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
Time Frame: Baseline, 3 months and 12 months
Average night and nap duration
Baseline, 3 months and 12 months
Daytime sleepiness
Time Frame: Baseline, 3 months and 12 months
Epworth Sleepiness Scale, Spanish version
Baseline, 3 months and 12 months
Change in Health-related quality of life
Time Frame: Baseline, 3 months and 12 months
EuroQol EQ-5D-3L
Baseline, 3 months and 12 months
Change in depressive symptoms
Time Frame: Baseline, 3 months and 12 months
10-item Geriatric Depression Scale
Baseline, 3 months and 12 months
Change in self-efficacy
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 3 months and 12 months
Derived from height and weight in kg/m2
Baseline, 3 months and 12 months
Change in waist circumference
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Change in blood pressure
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Change in resting heart rate
Time Frame: Baseline, 3 months and 12 months
Baseline, 3 months and 12 months
Safety during and after the intervention
Time Frame: 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
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI20/00657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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