A Multicomponent Physical Activity Intervention for Older Adults

NCT07729007 | Completed

• 1 other identifier: PI20/00657
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

  Baseline, 3 months and 12 months

Other Outcomes (13)

• Change in adherence to the Mediterranean diet

  Baseline, 3 months and 12 months

• Change in sleep duration

  Baseline, 3 months and 12 months

• Daytime sleepiness

  Baseline, 3 months and 12 months

Study Arms (3)

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.

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).

Behavioral: Exercise toolkit plus specialist support

Interventions

Exercise toolkit BEHAVIORAL

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

Exercise toolkit plus specialist support BEHAVIORAL

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.

Exercise toolkit plus specialist support

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

Universidad Autonoma de Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 27, 2026
• Study Start: March 6, 2023
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)