Clinical trial NCT05934578: Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
Official title: Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Univentricular Heart
Congenital Heart Disease
Lymphatic Abnormalities
Functional Capacity
Exercise Training
Quality of Life
Keywords: Lymphatic dysfunction
Near-Infrared Fluorescence Imaging
Fontan circulation
Plethysmography
Functional capacity
Aerobic exercise
Cardiac rehabilitation
Capillary filtration
Exercise training
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Copenhagen University Hospital, Denmark
name: University of Aarhus
First posted: 2023-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A longitudinal clinical trial, controlled and no-randomized. Intervention: Exercise (aerobic and light muscle resistance exercise)
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Assessing Peripheral Lymphatic Function Using Near-Infrared Fluorescence Imaging: Contraction Frequency Analysis over a 6-Minute Baseline
timeFrame: After 8 weeks of exercise training program or usual rotine
measure: Quantifying Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Assessment of Packet Velocity (cm/s) between ROIs.
timeFrame: After 8 weeks of exercise training program or usual rotine
measure: Assessing Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Determination of Pumping Pressure (mmHg).
timeFrame: After 8 weeks of exercise training program or usual rotine
Secondary outcomes:
measure: Assessment of Capillary Filtration Rate Using Venous Occlusion Plethysmography
timeFrame: After 8 weeks of exercise training program or usual rotine
measure: Functional capacity assessment 1
timeFrame: After 8 weeks of exercise training program or usual rotine
measure: "Functional Capacity Assessment through Cardiopulmonary Exercise Test: Predicted Peak VO2 (%) as an Indicator of Training Program Effectiveness
timeFrame: After 8 weeks of exercise training program or usual rotine
measure: Assessment of Quality of Life Using Short Form 36 Questionnaire: A Multi-Domain Analysis with Scores Ranging from 0 to 100
timeFrame: After 8 weeks of exercise training program or usual rotine
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coracao, Faculdade de Medicina da Universidade de Sao Paulo
state: Sao Paulo
Study officials:
References: