RBR-7bwk89s Effects of supervised physical exercise on functional capacity and quality of life of patients with Fontan-type circulat...

Date of registration: 04/16/2026 ^(mm/dd/yyyy)
Last approval date : 04/16/2026 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1339-1509

• Public title:

  en

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

  pt-br

  Efeitos do exercicício físico supervisionado na capacidade funcional e na qualidade de vida de pacientes com circulação tipo Fontan

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 94202525.2.0000.5462
    Issuing authority: Plataforma Brasil
  • 8.117.378
    Issuing authority: Parecer emitido peo comitê de ética em pesquisa do instituto dante pazzanese de cardiologia

Sponsors

• Primary sponsor: Instituto Dante Pazzanese de Cardiologia
• Secondary sponsor:
  • Institution: Instituto Dante Pazzanese de Cardiologia
• Supporting source:
  • Institution: Instituto Dante Pazzanese de Cardiologia

Health conditions

• Health conditions:

  en

  Univentricular Heart

  pt-br

  Coração Univentricular

• General descriptors for health conditions:

  en

  C14.240.400 Heart Defects, Congenital

  pt-br

  C14.240.400 Cardiopatias Congênitas

• Specific descriptors:

  en

  C14.240.400.990 Univentricular Heart

  pt-br

  C14.240.400.990 Coração Univentricular

Interventions

• Interventions:

  en

  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 program for 12 weeks. Control group: Approximately 25 patients will have regular clinical follow-up at the service, without participation in a structured cardiopulmonary rehabilitation program during the study period. These patients will receive general guidance according to routine care, without additional supervised intervention. Participants allocated to the control group will remain under regular clinical follow-up at the service, without participation in a structured cardiopulmonary rehabilitation program during the study period. These patients will receive general guidance according to routine care, without additional supervised intervention.

  pt-br

  Trata-se de um estudo clínico randomizado controlado de dois braços, não cego. Grupo experimental: 25 pacientes com circulação tipo Fontan serão submetidos a um programa estruturado de reabilitação cardiopulmonar supervisionada, com duração de 12 semanas. Grupo Controle: Cerca de 25 pacientes terão acompanhamento clínico habitual no serviço, sem participação em programa estruturado de reabilitação cardiopulmonar durante o período do estudo. Esses pacientes receberão orientações gerais conforme rotina assistencial, sem intervenção supervisionada adicional. Os participantes alocados no grupo controle permanecerão em acompanhamento clínico habitual no serviço, sem participação em programa estruturado de reabilitação cardiopulmonar durante o período do estudo. Esses pacientes receberão orientações gerais conforme rotina assistencial, sem intervenção supervisionada adicional.

• Descriptors:

  en

  E02.760.169.063.500.185 Cardiac Rehabilitation

  pt-br

  E02.760.169.063.500.185 Reabilitação Cardíaca

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 05/01/2026 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  50	-	8 Y	0

• Inclusion criteria:

  en

  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

  pt-br

  Idade igual ou superior a 8 anos; submetidos à cirurgia de Fontan há pelo menos 6 meses; clinicamente estáveis, com capacidade de realizar exercícios físicos e testes funcionais

• Exclusion criteria:

  en

  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%

  pt-br

  Contraindicação formal à prática de exercício físico ou ao teste cardiopulmonar; diagnóstico de arritmias graves, insuficiência cardíaca descompensada, pneumopatias graves, limitações motoras importantes ou saturação periférica de oxigênio em repouso inferior a 80%

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  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

  pt-br

  Espera-se encontrar um incremento do volume de oxigênio de pico maior ou igual a 2 ml/kg/min, avaliado pelo teste cardiopulmonar realizado pré e pós-intervenção

• Secondary outcomes:

  en

  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

  pt-br

  Espera-se aumentar a distância percorrida no teste de caminhada de seis minutos; aumentar força muscular avaliada por dinamometria manual; melhorar a qualidade de vida avaliada pelo Pediatric Quality of Life Inventory (PedsQL) – Cardiac Module

Contacts

• Public contact
  • Full name: Frederico Rodrigues Mendonça
  • • Address: Avenida Dr. Dante Pazzanese, Numero 500, Torre 11o andar
    • City: São Paulo / Brazil
    • Zip code: 04012-909
  • Phone: +55(21)977234110
  • Email: fred.rmrj@gmail.com
  • Affiliation: Instituto Dante Pazzanese de Cardiologia
   
• Scientific contact
  • Full name: Frederico Rodrigues Mendonça
  • • Address: Avenida Dr. Dante Pazzanese, Numero 500, Torre 11o andar
    • City: São Paulo / Brazil
    • Zip code: 04012-909
  • Phone: +55(21)977234110
  • Email: fred.rmrj@gmail.com
  • Affiliation: Instituto Dante Pazzanese de Cardiologia
   
• Site contact
  • Full name: Frederico Rodrigues Mendonça
  • • Address: Avenida Dr. Dante Pazzanese, Numero 500, Torre 11o andar
    • City: São Paulo / Brazil
    • Zip code: 04012-909
  • Phone: +55(21)977234110
  • Email: fred.rmrj@gmail.com
  • Affiliation: Instituto Dante Pazzanese de Cardiologia
   

Additional links:

• Download in ICTRP format