NCT02283255

Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training

Completed NA Last updated 7 December 2022

What this trial tests

NA trial testing Aerobic Exercise Training in Congenital Heart Disease in 60 participants. Completed in 30 October 2020.

Timeline

31 January 2013

Primary endpoint
30 January 2016

30 October 2020

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	31 January 2013
Primary completion	30 January 2016
Estimated completion	30 October 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Aerobic Exercise Training
• Inspiratory Muscle Training
• No Exercise Training

Conditions studied

• Congenital Heart Disease — all drugs for Congenital Heart Disease →
• Single Ventricle — all drugs for Single Ventricle →
• Univentricular Heart — all drugs for Univentricular Heart →

Sponsor

University of Sao Paulo

Who can join

Adults 12 to 30, any sex, with Congenital Heart Disease or Single Ventricle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles. In this operation, the subpulmonary ventricle is bypassed, connecting the systemic veins directly to the pulmonary arteries. The lack of a subpulmonary ventricle is associated with a nonpulsatile pulmonary flow and triggers a sequence of adaptive mechanisms along the life of these patients. The most frequent consequence of these adaptative mechanisms is the reduction in functional capacity, objectively measured by the decrease in peak oxygen consumption (VO2). So, cardiovascular and pulmonary functioning and skeletal muscle alterations can explain exercise intolerance in these patients.

Objectives: 1. To compare the cardiovascular, pulmonary, and musculoskeletal system variables in clinically stable Fontan patients with Healthy subjects; 2. To correlate the variables of the cardiovascular, pulmonary, and skeletal muscle with the functional capacity in Fontan patients; 3. To identify predictors of low functional capacity in this population; 4. To evaluate four-month aerobic exercise and inspiratory muscle training on functional capacity, pulmonary function, and autonomic control in patients after Fontan operation and compare to the group with no exercise training.

Methods: All subjects were submitted to cardiovascular, pulmonary, and skeletal muscle evaluation at baseline to perform a cross-sectional study comparing Fontan Patients (FP) with Healthy Controls (HC). In addition, the FP accepted to participate in the longitudinal clinical trial to evaluate exercise programs were randomized into three groups: Aerobic Exercise Training (AET), Inspiratory Muscle Training (IMT), and Non-exercise Training Group (NET, a control group). All patient groups (AET, IMT, NET) were reassessed after four months of training or under usual care.

Expected Outcomes: This study expects to demonstrate that impaired pulmonary function, altered neurovascular control, and reduced skeletal muscle could be an additional potential mechanism for reducing functional capacity in clinically stable Fontan patients. And this impairment could be diminished by exercise training, enhancing physical capacity, and exercise tolerance.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The molecular mechanisms of cardiac development and related diseases.
   Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
2. Physical activity interventions for people with congenital heart disease.
   Williams CA, Wadey C, Pieles G, Stuart G, et al · · 2020 · cited 40× · PMID 33112424 · DOI 10.1002/14651858.cd013400.pub2
3. Aerobic exercise and inspiratory muscle training increase functional capacity in patients with univentricular physiology after Fontan operation: A randomized controlled trial.
   Turquetto ALR, Dos Santos MR, Agostinho DR, Sayegh ALC, et al · · 2021 · cited 25× · PMID 33571562 · DOI 10.1016/j.ijcard.2021.01.058