NCT07330882

Brief Summary

Coronary artery disease (CAD) is a major chronic condition severely impacting population health in China. Our previous cohort studies revealed a high comorbidity rate between CAD and frailty, suggesting their interrelated equivalence as clinical syndromes with shared risk factors. In recent years, pilot integrated health management initiatives in China have demonstrated promising outcomes, yet evidence remains scarce regarding patients with concurrent CAD and frailty-a critical gap needing urgent resolution to achieve the "Healthy China 2030" strategic goals. Building on prior research, this project aims to systematically evaluate existing management models for patients with CAD and frailty, develop a tailored health management framework, and implement it in clinical settings through empirical studies. The model will be optimized according to regional and demographic variations, leveraging cardiac rehabilitation centers, exercise-based interventions, and internet-enabled technologies to enhance coordinated care. By improving exercise efficacy, mitigating frailty progression, and enhancing quality of life, this initiative seeks to establish a robust chronic disease management system. The findings will provide evidence for formulating regional health policy and insurance strategies in Anhui Province, ultimately improving standardized management rates for chronic diseases.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Oct 2024Jun 2027

Study Start

First participant enrolled

October 20, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

January 9, 2026

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

November 17, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

Myocardial IschemiaCardiac rehabilitationQuality of lifeFrailty

Outcome Measures

Primary Outcomes (2)

  • 6MWD

    Measuring the maximum distance within 6 minutes.

    1month,3 months, 6 months

  • The MOS item short from health survey

    Quality of life was assessed using the 36-Item Short Form Health Survey questionnaire

    1month,3 months, 6 months

Secondary Outcomes (7)

  • Frailty

    1month,3 months, 6 months

  • Grip strength

    1month,3 months, 6 months

  • Gait speed

    1month,3 months, 6 months

  • Physical activity level

    1month,3 months, 6 months

  • Systolic pressure/Diastolic pressure

    1month,3 months, 6 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention consists of two parts: Health management model: Establish a "hospital-home" full-process health management service chain based on mobile health. Firstly, cardiac specialist nurses conduct a comprehensive assessment of each patient's cardiac rehabilitation status and implement individualized interventions. The specific intervention procedures are: "Assess the patient's current condition and capabilities - Promote the patient's awareness of the current situation - Develop and revise the cardiac rehabilitation plan - Supervise the implementation of the cardiac rehabilitation plan."

Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology

Control group

ACTIVE COMPARATOR

During the patient's hospital stay and after discharge, cardiovascular internal medical staff provide them with routine medical,nursing services and health education. In terms of basic drug treatment, the principles of secondary prevention for coronary heart disease should be followed. Routine nursing care and health education were delivered through verbal instruction and the "317 Nursing Education Platform." They were also advised to maintain a healthy lifestyle and participate in appropriate physical activities.

Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology

Interventions

The development, application and evaluation of an innovative health management model for patients with coronary heart disease and frailty based on the "cardiac rehabilitation center" framework, exercise rehabilitation, and new technologies such as "mobile health".

Control groupIntervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Coronary heart disease;
  • Proficiency in smartphone use;
  • Absence of visual, auditory, cognitive, or motor impairments.

You may not qualify if:

  • Inability or unwillingness to provide informed consent;
  • Physical or cognitive limitations preventing app operation;
  • Inability to attend in-person follow-up visits;
  • Concurrent severe comorbidities or malignancies, such as severe valvular heart disease, New York Heart Association class IV heart failure, severe aortic regurgitation, cancer, end-stage renal or liver disease;
  • Any other condition that could potentially impede exercise participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Location

MeSH Terms

Conditions

Coronary DiseaseMyocardial IschemiaFrailty

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tong Zhou

    The First Affiliated Hospital of Bengbu Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 9, 2026

Study Start

October 20, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

January 9, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations