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A prospective study of individualized exercise rehabilitation for improving long-term quality of life of functional single ventricles

A randomized, controlled, prospective study on the effect of aerobic combined anti-group exercise on the cardiac function of children with functional single ventricle Fontan operation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035663
Enrollment
Unknown
Registered
2020-08-15
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

functional single ventricle

Interventions

intervention group:Regular aerobic and anti-group exercise

Sponsors

Heart Center, Shanghai Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1) Received total cavapulmonary anastomosis (TCPC), namely Fontan operation, at Shanghai Children's Medical Center; 2) More than 12 months after Fontan surgery; 3) Aged>=6 years old; 4) NYHA grade I-II; 5) Able to complete the exercise specified by the exercise prescription; 6) Obtain written consent from guardian.

Exclusion criteria

Exclusion criteria: 1) Hospitalized for acute decompensated heart failure within 3 months; 2) Currently, inotropic drugs are injected intravenously; 3) Echocardiogram reveals known Fontan cycle anastomotic obstruction, pulmonary artery stenosis, or pulmonary vein stenosis (pressure difference greater than 4mmHg); 4) Diagnosis of active protein-losing enteropathy, plastic bronchitis and liver cirrhosis within 3 years; 5) CMR suggests single lung physiology: more than 80% of the blood flow goes to one lung; 6) Ventricular dysfunction, SVEF measured by CMR 160mmHg, diastolic blood pressure> 100mmHg; 9) Hypotension: systolic blood pressure 120 BPM; 11) Atrial fibrillation and atrial flutter within 90 days before enrollment; 12) NT-bnp>3000; 13) General exclusions: psychiatric and/or social barriers, patients with a history of severe allergies or multiple drug allergies, refusal to provide written informed consent/consent, other known organ dysfunction.

Design outcomes

Primary

MeasureTime frame
Cardiac Index;

Countries

China

Contacts

Public ContactHaibo Zhang

Shanghai Children's Medical Center

zhanghaibo@scmc.com.cn+86 18930830772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026