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Completed

NCT Number: NCT07729007

A Multicomponent Physical Activity Intervention for Older Adults

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autonoma de Madrid

Madrid, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Change in 30-Second Chair Stand Test

    Time frame: Baseline, 3 months and 12 months

  2. Change in hand grip strength

    Time frame: Baseline, 3 months and 12 months

Secondary outcomes

  1. Change in 2-Minute Step Test

    Time frame: Baseline, 3 months and 12 months

  2. Change in Timed Up and Go test

    Time frame: Baseline, 3 months and 12 months

  3. Change in Back Scratch Test

    Time frame: Baseline, 3 months and 12 months

  4. Change in Chair Sit-and-Reach Test

    Time frame: Baseline, 3 months and 12 months

  5. 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)

  6. 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)

  7. 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

  8. Change in wrist-worn accelerometer activity

    Time frame: Baseline, 3 months and 12 months

    Total movement (mg)

  9. Change in wrist-worn step patterns

    Time frame: Baseline, 3 months and 12 months

    Daily steps and cadence

Other outcomes

  1. 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.

  2. Change in sleep duration

    Time frame: Baseline, 3 months and 12 months

    Average night and nap duration

  3. Daytime sleepiness

    Time frame: Baseline, 3 months and 12 months

    Epworth Sleepiness Scale, Spanish version

  4. Change in Health-related quality of life

    Time frame: Baseline, 3 months and 12 months

    EuroQol EQ-5D-3L

  5. Change in depressive symptoms

    Time frame: Baseline, 3 months and 12 months

    10-item Geriatric Depression Scale

  6. Change in self-efficacy

    Time frame: Baseline, 3 months and 12 months

    Spanish General Self-Efficacy Scale; 10 items, 4-point Likert, higher = greater

  7. 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.

  8. Change in body mass index

    Time frame: Baseline, 3 months and 12 months

    Derived from height and weight in kg/m2

  9. Change in waist circumference

    Time frame: Baseline, 3 months and 12 months

  10. Change in blood pressure

    Time frame: Baseline, 3 months and 12 months

  11. Change in resting heart rate

    Time frame: Baseline, 3 months and 12 months

  12. 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.

  13. Economic costs of the intervention

    Time frame: Baseline and 3 months

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Registry information

Official study title

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

Acronym: ActiveKIT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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