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Efficacy of a Navigated, Home-Based, and Nuanced CPET-Guided Exercise Rehabilitation on Multidimensional Outcomes in Pediatric Chronic Heart Failure: A Multicenter, Randomized Controlled Trial (ENHANCE-PCHF Trial)

Efficacy of a Navigated, Home-Based, and Nuanced CPET-Guided Exercise Rehabilitation on Multidimensional Outcomes in Pediatric Chronic Heart Failure: A Multicenter, Randomized Controlled Trial (ENHANCE-PCHF Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125271
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Intervention Group:Routine care + home-based exercise rehabilitation guided by CPET (individualized intensity prescription based on CPET results, real-time heart rate monitoring using smart wristband,
Control Group:Only routine care (general advice of 'activity as tolerated', no smart devices, no active feedback)

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 6–18 years; 2. Meets diagnostic criteria for chronic heart failure (CHF) in children, with stable condition for >3 months (NYHA functional class I–III); 3. Underlying etiology includes congenital heart disease, cardiomyopathy, etc.; 4. Informed consent obtained from both the pediatric patient and the guardians.

Exclusion criteria

Exclusion criteria: 1. Presence of contraindications to exercise (e.g., cardiomyopathy with an arrhythmogenic mechanism, uncontrolled pulmonary hypertension, ventricular inflow/outflow tract obstruction); 2. Participation in structured exercise training within the past 3 months); 3. Estimated survival <1 year or planned heart transplantation within 6 months); 4. Presence of severe neurological or musculoskeletal diseases that preclude cooperation with exercise); 5. Inability to proficiently use a smartphone or smart device (even with guidance).

Design outcomes

Primary

MeasureTime frame
Change in peak oxygen consumption (Peak VO2) from baseline;

Secondary

MeasureTime frame
Change in PedsQL Total Score and Domain Scores;Change in 6-Minute Walk Distance (6MWD);Change in Left Ventricular Ejection Fraction (LVEF), Global Longitudinal Strain (GLS), and NT-proBNP Levels;All-Cause and Heart Failure-Related Rehospitalization Rates;Change in Peak Oxygen Consumption (Peak VO?) from Baseline;

Countries

China

Contacts

Public ContactXiao Yanyan

Beijing Children's Hospital, Capital Medical University

xiaoyanyan@sina.com+86 136 6126 3039

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026