Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty
12 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
64
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: yajie xie
- Número de teléfono: +8616620323694
- Correo electrónico: 16620323694@163.com
Ubicaciones de estudio
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Gansu
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Lanzhou, Gansu, Porcelana, 730000
- Affiliated Hospital of Gansu University of Chinese Medicine
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Contacto:
- yajie xie
- Número de teléfono: +8616620323694
- Correo electrónico: 16620323694@163.com
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Contacto:
- Correo electrónico: 16620323694@163.com
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Investigador principal:
- Yajie Xie
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Average Daily Sedentary Time
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Longest Continuous Sedentary Bout Duration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yajie Xie, Gansu University of Chinese Medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de enero de 2027
Finalización del estudio (Estimado)
1 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de agosto de 2026
Publicado por primera vez (Actual)
13 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ITHBC-SB-2026-061
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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