A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)

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: Completed
• Conditions: Physical Activity; Fitness; Older Adults (65 Years and Older); Inactive People
• Intervention / Treatment: Behavioral: Exercise toolkit; Behavioral: Exercise toolkit plus specialist support

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Universidad Autonoma de Madrid

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change in 30-Second Chair Stand Test	Baseline, 3 months and 12 months
Change in hand grip strength	Baseline, 3 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 2-Minute Step Test		Baseline, 3 months and 12 months
Change in Timed Up and Go test		Baseline, 3 months and 12 months
Change in Back Scratch Test		Baseline, 3 months and 12 months
Change in Chair Sit-and-Reach Test		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)	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)	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	Baseline, 3 months and 12 months
Change in wrist-worn accelerometer activity	Total movement (mg)	Baseline, 3 months and 12 months
Change in wrist-worn step patterns	Daily steps and cadence	Baseline, 3 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adherence to the Mediterranean diet	14-item Mediterranean Diet Adherence Screener, Score 0-14, higher = better adherence.	Baseline, 3 months and 12 months
Change in sleep duration	Average night and nap duration	Baseline, 3 months and 12 months
Daytime sleepiness	Epworth Sleepiness Scale, Spanish version	Baseline, 3 months and 12 months
Change in Health-related quality of life	EuroQol EQ-5D-3L	Baseline, 3 months and 12 months
Change in depressive symptoms	10-item Geriatric Depression Scale	Baseline, 3 months and 12 months
Change in self-efficacy	Spanish General Self-Efficacy Scale; 10 items, 4-point Likert, higher = greater	Baseline, 3 months and 12 months
Change in physical activity enjoyment	Single-item score ranging from 1 to 10; higher scores indicate greater enjoyment.	Baseline, 3 months and 12 months
Change in body mass index	Derived from height and weight in kg/m2	Baseline, 3 months and 12 months
Change in waist circumference		Baseline, 3 months and 12 months
Change in blood pressure		Baseline, 3 months and 12 months
Change in resting heart rate		Baseline, 3 months and 12 months
Safety during and after the intervention	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		Baseline and 3 months

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID 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