Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty
2026年8月12日 更新者：Xie Yajie、Gansu University of Chinese Medicine
Development and Application of a Sedentary Behavior Intervention Program Based on the Integrated Theory of Health Behavior Change for Older Adults With Coronary Heart Disease and Frailty
This study aims to evaluate the feasibility and effectiveness of a sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in older adults with coronary heart disease and frailty.
Participants will be randomly assigned to an intervention group or a control group.
The intervention is designed around the three core components of ITHBC-knowledge and beliefs, self-regulation skills and abilities, and social facilitation-to help participants reduce sedentary behavior, improve physical activity, and enhance their ability to manage health-related behaviors.
The study will include a 1-month intervention period followed by a 2-month follow-up period, with a total study duration of 3 months for each participant.
Changes in sedentary behavior and other health-related outcomes will be assessed throughout the study period.
調査の概要
詳細な説明
This study is designed to develop and evaluate a sedentary behavior intervention for older adults with coronary heart disease and frailty based on the Integrated Theory of Health Behavior Change (ITHBC). The intervention framework incorporates the three major components of ITHBC: knowledge and beliefs, self-regulation skills and abilities, and social facilitation.
The intervention is intended to improve participants' knowledge and beliefs regarding sedentary behavior and its health consequences, strengthen their motivation and confidence for behavior change, enhance self-regulation skills such as goal setting, self-monitoring, action planning, feedback, and behavioral adjustment, and provide appropriate professional, family, and social support. These strategies are integrated to facilitate the initiation and maintenance of sedentary behavior change.
The study consists of a 1-month structured intervention period followed by a 2-month follow-up period, resulting in a total study duration of 3 months for each participant. Participants in the intervention group will receive the ITHBC-based sedentary behavior intervention according to the study protocol, while participants in the control group will receive the comparator specified in the protocol. The effectiveness of the intervention will be evaluated by comparing changes in sedentary behavior and other prespecified health-related outcomes between the groups during the intervention and follow-up periods.
研究の種類
介入
入学 (推定)
64
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。
研究連絡先
- 名前：yajie xie
- 電話番号：+8616620323694
- メール：16620323694@163.com
研究場所
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Gansu
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Lanzhou、Gansu、中国、730000
- Affiliated Hospital of Gansu University of Chinese Medicine
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コンタクト：
- yajie xie
- 電話番号：+8616620323694
- メール：16620323694@163.com
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コンタクト：
-
主任研究者：
- Yajie Xie
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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
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 60 years or older.
- Diagnosis of stable coronary artery disease according to the Chinese Primary -Care Guideline for Stable Coronary Artery Disease (2020).
- Canadian Cardiovascular Society (CCS) angina class I or II.
- Fried Frailty Phenotype score of 1 or higher, including participants with pre-frailty (score 1-2) or frailty (score 3-5).
- Total sedentary time of 6 hours or more per day.
- The participant or the participant's primary caregiver is able to use the WeChat application.
- Able and willing to provide informed consent and voluntarily participate in the study.
Exclusion Criteria:
- Currently participating in another research study.
- Presence of a malignant tumor.
- Presence of a severe infectious disease.
- Presence of a physical impairment that substantially limits limb mobility.
- Presence of a language impairment that prevents effective communication or -completion of study assessments.
- Presence of cognitive impairment that prevents understanding of study procedures or completion of study assessments.
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ITHBC-Based Sedentary Behavior Intervention
Participants in this arm will receive a 1-month sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC), in addition to usual care.
The intervention incorporates strategies targeting knowledge and beliefs, self-regulation skills and abilities, and social facilitation.
Participants will subsequently be followed for 2 months, resulting in a total study duration of 3 months.
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The intervention is a 1-month nurse-delivered sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC).
It addresses three core components of ITHBC: knowledge and beliefs, self-regulation skills and abilities, and social facilitation.
Intervention strategies include health education related to sedentary behavior and coronary heart disease, individualized goal setting, self-monitoring, action planning, feedback, and professional and family/social support to facilitate reduction of sedentary behavior and promote physical activity.
After the 1-month intervention period, participants will receive a 2-month follow-up to support maintenance of behavior change.
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介入なし：Usual Care
Participants in this arm will receive usual care provided by the clinical team and will not receive the ITHBC-based sedentary behavior intervention.
Participants will be followed for the same 3-month study period as the intervention group.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Average Daily Sedentary Time
時間枠：Baseline, Day 8, Month 1, and Month 3
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Average daily sedentary time will be assessed using the Older Adults Sedentary Behavior Questionnaire.
The questionnaire assesses sedentary behavior during the previous 7 days across seven common sedentary domains, including watching television or videos, using a mobile phone or listening to music or radio, reading, socializing with family or friends, engaging in sedentary hobbies, resting or napping, and other sedentary activities.
Time spent in each domain is reported in 15-minute increments from 0 minutes to 6 hours.
Daily total sedentary time will be derived from the reported sedentary time across the seven domains and expressed as time spent sedentary per day.
Lower values indicate less sedentary time.
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Baseline, Day 8, Month 1, and Month 3
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Longest Continuous Sedentary Bout Duration
時間枠：Baseline, Day 8, Month 1, and Month 3
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The longest continuous sedentary bout duration will be assessed using the Older Adults Sedentary Behavior Questionnaire.
Participants will report the longest uninterrupted period of sitting, reclining, or lying during the day.
Responses range from 0 minutes to 6 hours in 15-minute increments.
A shorter duration indicates less prolonged sedentary behavior.
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Baseline, Day 8, Month 1, and Month 3
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Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer
時間枠：Baseline, Day 8, Month 1, and Month 3
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The frequency of prolonged sedentary bouts will be assessed using the Older Adults Sedentary Behavior Questionnaire.
Participants will report the number of times per day that they remain sitting, reclining, or lying continuously for 30 minutes or longer.
Response options range from 0 times to 10 or more times per day.
A lower frequency indicates fewer prolonged sedentary bouts.
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Baseline, Day 8, Month 1, and Month 3
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Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior
時間枠：Baseline, Day 8, Month 1, and Month 3
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Self-efficacy for reducing sedentary behavior will be assessed using the Chinese version of the Self-Efficacy to Reduce Sedentary Behavior (SRSB) Scale.
The scale contains 9 items, each rated on a 5-point scale from 1 ("not at all confident") to 5 ("very confident").
The total score ranges from 9 to 45, with higher scores indicating greater confidence in reducing sedentary behavior.
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Baseline, Day 8, Month 1, and Month 3
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Change From Baseline in Fried Frailty Phenotype Score
時間枠：Baseline, Month 1，Month 3
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Frailty will be assessed using the Fried Frailty Phenotype, which includes five criteria: unintentional weight loss, reduced grip strength, exhaustion, slow walking speed, and low physical activity.
Each criterion contributes 1 point, resulting in a total score ranging from 0 to 5. A score of 0 indicates robust status, 1-2 indicates pre-frailty, and 3-5 indicates frailty.
Higher scores indicate greater frailty.
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Baseline, Month 1，Month 3
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Change From Baseline in Health-Related Quality of Life Assessed by the SF-36
時間枠：Baseline, Month 1 and Month 3
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Health-related quality of life will be assessed using the Chinese version of the 36-Item Short Form Health Survey (SF-36).
The instrument contains 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
Higher scores indicate better health-related quality of life.
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Baseline, Month 1 and Month 3
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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。
捜査官
- 主任研究者：Yajie Xie、Gansu University of Chinese Medicine
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 (推定)
2026年9月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年1月1日
試験登録日
最初に提出
2026年8月10日
QC基準を満たした最初の提出物
2026年8月12日
最初の投稿 (実際)
2026年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月13日
QC基準を満たした最後の更新が送信されました
2026年8月12日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- ITHBC-SB-2026-061
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be made publicly available because no formal data-sharing plan has been established for this study.
Study data will be managed and stored in accordance with the approved study protocol and institutional requirements for participant confidentiality and data protection.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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