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Effects of supervised physical exercise on functional capacity and quality of life of patients with Fontan-type circulation

Effects of supervised cardiopulmonary rehabilitation on the functional capacity of pacientes with Fontan-type circulation: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7bwk89s
Enrollment
50
Registered
2026-04-16
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Univentricular Heart Heart Defects, Congenital

Interventions

This is a two-arm, randomized controlled, non-blinded clinical study. Experimental group: 25 patients with Fontan-type circulation will undergo a structured supervised cardiopulmonary rehabilitation p

Sponsors

Instituto Dante Pazzanese de Cardiologia
Lead Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborator

Eligibility

Age
8 Years to No maximum

Inclusion criteria

Inclusion criteria: Age equal to or greater than 8 years; having undergone Fontan surgery at least 6 months ago; clinically stable, with the ability to perform physical exercises and functional tests

Exclusion criteria

Exclusion criteria: Formal contraindication to physical exercise or cardiopulmonary testing; diagnosis of severe arrhythmias, decompensated heart failure, severe lung diseases, significant motor limitations, or resting peripheral oxygen saturation below 80%

Design outcomes

Primary

MeasureTime frame
An increase in peak oxygen volume of greater than or equal to 2 ml/kg/min is expected, assessed by the cardiopulmonary test performed pre- and post-intervention

Secondary

MeasureTime frame
It is expected to increase the distance covered in the six-minute walk test; increase muscle strength assessed by hand dynamometry; improve quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL) – Cardiac Module

Countries

BR

Contacts

Public ContactFrederico Mendonça

Instituto Dante Pazzanese de Cardiologia

fred.rmrj@gmail.com+55(21)977234110

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026