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.
調査の概要
状態
状態
完了
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (実際)
入学
201
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Madrid、スペイン
- Universidad Autonoma de Madrid
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
3
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
介入なし：Usual care
Standardized written information consistent with current public health recommendations on multicomponent physical activity to maintain or improve physical function.
|
|
|
実験的：Exercise toolkit
A low-cost, easy-to-use, home-based exercise toolkit designed to promote multicomponent physical activity and improve physical function.
|
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
|
|
実験的：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).
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in 30-Second Chair Stand Test
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
Change in hand grip strength
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in 2-Minute Step Test
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Timed Up and Go test
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Back Scratch Test
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in Chair Sit-and-Reach Test
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in the International Fitness Scale
時間枠：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)
|
Baseline, 3 months and 12 months
|
|
Change in the IMPaCT physical activity and sedentary behavior questionnaire
時間枠：Baseline, 3 months and 12 months
|
Intensity, duration, type and context of PA (leisure, transport, occupational, domestic)
|
Baseline, 3 months and 12 months
|
|
Change in wrist-worn accelerometer behaviors
時間枠：Baseline, 3 months and 12 months
|
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
時間枠：Baseline, 3 months and 12 months
|
Total movement (mg)
|
Baseline, 3 months and 12 months
|
|
Change in wrist-worn step patterns
時間枠：Baseline, 3 months and 12 months
|
Daily steps and cadence
|
Baseline, 3 months and 12 months
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in adherence to the Mediterranean diet
時間枠：Baseline, 3 months and 12 months
|
14-item Mediterranean Diet Adherence Screener, Score 0-14, higher = better adherence.
|
Baseline, 3 months and 12 months
|
|
Change in sleep duration
時間枠：Baseline, 3 months and 12 months
|
Average night and nap duration
|
Baseline, 3 months and 12 months
|
|
Daytime sleepiness
時間枠：Baseline, 3 months and 12 months
|
Epworth Sleepiness Scale, Spanish version
|
Baseline, 3 months and 12 months
|
|
Change in Health-related quality of life
時間枠：Baseline, 3 months and 12 months
|
EuroQol EQ-5D-3L
|
Baseline, 3 months and 12 months
|
|
Change in depressive symptoms
時間枠：Baseline, 3 months and 12 months
|
10-item Geriatric Depression Scale
|
Baseline, 3 months and 12 months
|
|
Change in self-efficacy
時間枠：Baseline, 3 months and 12 months
|
Spanish General Self-Efficacy Scale; 10 items, 4-point Likert, higher = greater
|
Baseline, 3 months and 12 months
|
|
Change in physical activity enjoyment
時間枠：Baseline, 3 months and 12 months
|
Single-item score ranging from 1 to 10; higher scores indicate greater enjoyment.
|
Baseline, 3 months and 12 months
|
|
Change in body mass index
時間枠：Baseline, 3 months and 12 months
|
Derived from height and weight in kg/m2
|
Baseline, 3 months and 12 months
|
|
Change in waist circumference
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in blood pressure
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Change in resting heart rate
時間枠：Baseline, 3 months and 12 months
|
Baseline, 3 months and 12 months
|
|
|
Safety during and after the intervention
時間枠：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.
|
3 months and 12 months
|
|
Economic costs of the intervention
時間枠：Baseline and 3 months
|
Baseline and 3 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2023年3月6日
一次修了 (実際)
一次修了
2025年3月14日
研究の完了 (実際)
研究の完了
2025年3月14日
試験登録日
最初に提出
最初に提出
2026年7月20日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月22日
最初の投稿 (実際)
最初の投稿
2026年7月27日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月27日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。