A Multicomponent Physical Activity Intervention for Older Adults

NCT07729007 — Not applicable, Completed, 201 participants, Universidad Autonoma de Madrid

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

RegistryNCT07729007, acronym ActiveKIT
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment201 (Actual)
SponsorUniversidad Autonoma de Madrid (Other)
ConditionsOlder Adults (65 Years and Older), Inactive People, Fitness, Physical Activity
InterventionsExercise toolkit, Exercise toolkit plus specialist support (Behavioral)
Datesstart 2023-03-06, primary completion 2025-03-14, completion 2025-03-14, first posted 2026-07-27, last updated 2026-07-27
Locations1 site in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Older Adults (65 Years and Older) All trials for Inactive People All trials of Exercise toolkit All trials of Exercise toolkit plus specialist support

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Usual careNo interventionStandardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function.
Exercise toolkitExperimentalBehavioral: 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 supportExperimentalBehavioral: 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).
  • 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.

+Outcome measures

Primary outcomes

  • 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

  • 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]: 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)
  • Change in the IMPaCT physical activity and sedentary behavior questionnaire [Baseline, 3 months and 12 months]: Intensity, duration, type and context of PA (leisure, transport, occupational, domestic)
  • Change in wrist-worn accelerometer behaviors [Baseline, 3 months and 12 months]: Minutes in moderate-to vigorous physical activity, light-intensity physical activity, and sedentary time
  • Change in wrist-worn accelerometer activity [Baseline, 3 months and 12 months]: Total movement (mg)
  • Change in wrist-worn step patterns [Baseline, 3 months and 12 months]: Daily steps and cadence

Other outcomes

  • Change in adherence to the Mediterranean diet [Baseline, 3 months and 12 months]: 14-item Mediterranean Diet Adherence Screener, Score 0-14, higher = better adherence.
  • Change in sleep duration [Baseline, 3 months and 12 months]: Average night and nap duration
  • Daytime sleepiness [Baseline, 3 months and 12 months]: Epworth Sleepiness Scale, Spanish version
  • Change in Health-related quality of life [Baseline, 3 months and 12 months]: EuroQol EQ-5D-3L
  • Change in depressive symptoms [Baseline, 3 months and 12 months]: 10-item Geriatric Depression Scale
  • Change in self-efficacy [Baseline, 3 months and 12 months]: Spanish General Self-Efficacy Scale; 10 items, 4-point Likert, higher = greater
  • Change in physical activity enjoyment [Baseline, 3 months and 12 months]: Single-item score ranging from 1 to 10; higher scores indicate greater enjoyment.
  • Change in body mass index [Baseline, 3 months and 12 months]: Derived from height and weight in kg/m2
  • 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 [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.
  • Economic costs of the intervention [Baseline and 3 months]

+Eligibility

Sex: All, ages: 65 Years to any, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Universidad Autonoma de MadridMadridSpain