A Multicomponent Physical Activity Intervention for Older Adults (ActiveKIT)
2026年7月22日 更新者：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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
201
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Madrid、西班牙
- Universidad Autonoma de Madrid
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Usual care
Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function.
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实验性的：Exercise toolkit
A low-cost, easy-to-use, home-based exercise toolkit designed to promote multicomponent physical activity and improve physical function.
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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
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实验性的：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).
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in 30-Second Chair Stand Test
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in hand grip strength
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in 2-Minute Step Test
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in Timed Up and Go test
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in Back Scratch Test
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in Chair Sit-and-Reach Test
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in the International Fitness Scale
大体时间：Baseline, 3 months and 12 months
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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)
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Baseline, 3 months and 12 months
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Change in the IMPaCT physical activity and sedentary behavior questionnaire
大体时间：Baseline, 3 months and 12 months
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Intensity, duration, type and context of PA (leisure, transport, occupational, domestic)
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Baseline, 3 months and 12 months
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Change in wrist-worn accelerometer behaviors
大体时间：Baseline, 3 months and 12 months
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Minutes in moderate-to vigorous physical activity, light-intensity physical activity, and sedentary time
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Baseline, 3 months and 12 months
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Change in wrist-worn accelerometer activity
大体时间：Baseline, 3 months and 12 months
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Total movement (mg)
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Baseline, 3 months and 12 months
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Change in wrist-worn step patterns
大体时间：Baseline, 3 months and 12 months
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Daily steps and cadence
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Baseline, 3 months and 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in adherence to the Mediterranean diet
大体时间：Baseline, 3 months and 12 months
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14-item Mediterranean Diet Adherence Screener, Score 0-14, higher = better adherence.
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Baseline, 3 months and 12 months
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Change in sleep duration
大体时间：Baseline, 3 months and 12 months
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Average night and nap duration
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Baseline, 3 months and 12 months
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Daytime sleepiness
大体时间：Baseline, 3 months and 12 months
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Epworth Sleepiness Scale, Spanish version
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Baseline, 3 months and 12 months
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Change in Health-related quality of life
大体时间：Baseline, 3 months and 12 months
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EuroQol EQ-5D-3L
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Baseline, 3 months and 12 months
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Change in depressive symptoms
大体时间：Baseline, 3 months and 12 months
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10-item Geriatric Depression Scale
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Baseline, 3 months and 12 months
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Change in self-efficacy
大体时间：Baseline, 3 months and 12 months
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Spanish General Self-Efficacy Scale; 10 items, 4-point Likert, higher = greater
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Baseline, 3 months and 12 months
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Change in physical activity enjoyment
大体时间：Baseline, 3 months and 12 months
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Single-item score ranging from 1 to 10; higher scores indicate greater enjoyment.
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Baseline, 3 months and 12 months
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Change in body mass index
大体时间：Baseline, 3 months and 12 months
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Derived from height and weight in kg/m2
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Baseline, 3 months and 12 months
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Change in waist circumference
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in blood pressure
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Change in resting heart rate
大体时间：Baseline, 3 months and 12 months
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Baseline, 3 months and 12 months
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Safety during and after the intervention
大体时间：3 months and 12 months
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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.
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3 months and 12 months
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Economic costs of the intervention
大体时间：Baseline and 3 months
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Baseline and 3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年3月6日
初级完成 (实际的)
2025年3月14日
研究完成 (实际的)
2025年3月14日
研究注册日期
首次提交
2026年7月20日
首先提交符合 QC 标准的
2026年7月22日
首次发布 (实际的)
2026年7月27日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年7月22日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.