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Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty

12 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Gansu
      • Lanzhou, Gansu, Cina, 730000
        • Affiliated Hospital of Gansu University of Chinese Medicine
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Yajie Xie

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: ITHBC-Based Sedentary Behavior Intervention
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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Average Daily Sedentary Time
Lasso di tempo: Baseline, Day 8, Month 1, and Month 3
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.
Baseline, Day 8, Month 1, and Month 3

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Longest Continuous Sedentary Bout Duration
Lasso di tempo: Baseline, Day 8, Month 1, and Month 3
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.
Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer
Lasso di tempo: Baseline, Day 8, Month 1, and Month 3
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.
Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior
Lasso di tempo: Baseline, Day 8, Month 1, and Month 3
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.
Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Fried Frailty Phenotype Score
Lasso di tempo: Baseline, Month 1，Month 3
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.
Baseline, Month 1，Month 3
Change From Baseline in Health-Related Quality of Life Assessed by the SF-36
Lasso di tempo: Baseline, Month 1 and Month 3
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.
Baseline, Month 1 and Month 3

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gansu University of Chinese Medicine

Investigatori

  • Investigatore principale: Yajie Xie, Gansu University of Chinese Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

10 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 agosto 2026

Primo Inserito (Effettivo)

13 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ITHBC-SB-2026-061

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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