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

NCT ID: NCT05934578

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2022-12-22

Brief Summary

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)

Detailed Description

The study population is patients submitted to Fontan operation to treat complex congenital heart disease (univentricular circulation), who are followed at InCor Heart Institute in Sao Paulo.

The investigators will perform all measures baseline and after 36 sessions of aerobic exercise and light resistance (exercise group) or after eight weeks in usual care (control group).

Conditions

Univentricular Heart; Congenital Heart Disease; Lymphatic Abnormalities; Functional Capacity; Exercise Training; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fontan Group - Exercise Training

Online rehabilitation: 36 sessions of aerobic exercise training for two months

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: OTHER

Aerobic and light muscle resistance exercise by online cardiovascular rehabilitation

Fontan Control Group - No Exercise Training

Patients will not participate in the exercise program and will continue with their usual routine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

Aerobic and light muscle resistance exercise by online cardiovascular rehabilitation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Fontan circulation
• Age above 18 years
• Agreeing to participate in the study and signing the informed consent form.

Exclusion Criteria

• Motor alterations make it impossible to perform the cardiopulmonary test
• Mental illness
• Syndromes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Copenhagen University Hospital, Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Aida Luiza R Turquetto

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto do Coracao, Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAAE 61404222.6.0000.0068

Identifier Type: -

Identifier Source: org_study_id