NCT05934578

Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training

Completed NA Last updated 28 July 2023

What this trial tests

NA trial testing Exercise training in Univentricular Heart in 20 participants. Completed in 22 December 2022.

Timeline

26 September 2022

Primary endpoint
22 December 2022

22 December 2022

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	26 September 2022
Primary completion	22 December 2022
Estimated completion	22 December 2022
Sites	1 location across Brazil

Drugs / interventions tested

• Exercise training

Conditions studied

• Univentricular Heart — all drugs for Univentricular Heart →
• Congenital Heart Disease — all drugs for Congenital Heart Disease →
• Lymphatic Abnormalities — all drugs for Lymphatic Abnormalities →
• Functional Capacity — all drugs for Functional Capacity →

Sponsor

University of Sao Paulo

Who can join

18 and older, any sex, with Univentricular Heart or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The Fontan operation has been used to treat complex cardiac anomalies with a single-functioning ventricle. A study performed by Instituto do Coracão-Hospital das Clínicas-Universidade de Sao Paulo (InCor/HCFMUSP)-Brazil, Hospital das Clínicas of Ribeirão Preto-Brazil, department of the University of Aarhus, and Rigshospitalet, Denmark demonstrated an impairment peripheral lymphatic function in Fontan patients compared with healthy controls. However, the ability to increase the frequency of contractions is impaired when stressed by hyperthermia. Lymph vessels in Fontan patients were unable to respond usually. The participants were only able to increase the frequency of contraction twice during stress, compared to a five-fold increase among healthy controls. At the microcirculation level, Fontan patients filtered less fluid into the capillaries interstitial space than healthy controls at venous occlusion pressure. Studies carried out at InCor/HCFMUSP demonstrated that supervised aerobic exercise training improves the functional capacity and neurovascular control in Fontan patients compared to the non-training control group. However, the effect of aerobic exercise and light muscle resistance performed through online rehabilitation has not yet been demonstrated in peripheral lymphatic function and microcirculation. Aim: Evaluate the effects of an aerobic and light muscle resistance exercise program on peripheral lymphatic function, capillary filtration, functional capacity, and quality of life in adults with Fontan circulation. Methods: The function of the superficial lymphatic vessels in the lower leg will be investigated during rest in supine and standing positions, using near-infrared fluorescence imaging using Indocyanine Green (ICG; Verdye, Diagnostic Green GmbH, Germany). The variables analyzed are contraction frequency (contraction/minute), pumping Pressure (mmHg), and packet velocity. Venous congestion plethysmography will perform to analyze the capillary filtration and cardiopulmonary exercise test for functional capacity. The quality of life will be evaluated using the SF-36 Short-Form questionnaire. Expected results: the physical training improves peripheral lymphatic function, capillary filtration, functional capacity, and quality of life in patients with biventricular compared to the control group (no exercise training)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Online rehabilitation in adult Fontan patients: Effects in functional capacity, lymphatic function and quality of life.
   Turquetto ALR, Amato LP, Thorup L, Kelly B, et al · · 2025 · PMID 40482833 · DOI 10.1016/j.ijcard.2025.133480