Cardiovascular, Pulmonary and Skeletal Muscle Evaluation in Late Postoperative Period of the Fontan Surgery

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT02283255

Collaborator

InCor Heart Institute (Other), Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Introduction: Different variations of the Fontan operation has been used to treat complex cardiac anomalies with a single functional ventricle. This procedure has substantially improved quality of life and survival in patients with these complex cardiac anomalies. However, the cardiovascular and pulmonary functioning as well as skeletal muscle alterations that can explain the exercise intolerance in these patients is still poorly understood.

Objectives: 1) To evaluate effects of different exercise programs on adolescents and adults with Fontan circulation.

Methods: A long-term randomized clinical study that will include 60 patients between 12 and 30 years, submitted to total cavopulmonary connection for at least 5 years post operative at the Heart Institute, University of São Paulo Medical School. The patients will be divided into four groups: 1) Exercise training with aerobic exercise + lower and upper limb strength exercise (GTF-I); 2) Respiratory training with respiratory muscle exercise (GTF-II); 3) Exercise training with aerobic exercise + lower and upper limb strength exercise + Respiratory training with respiratory muscle exercise (GTF-III); and A non-exercise group as control group (GNTF-IV). The patients will be revaluated after the 4-month period of intervention.

Expected Outcomes: The investigators expect to demonstrate that exercise training and respiratory training can substantially improve the cardiovascular and pulmonary responses and skeletal muscle system in patients with univentricular circulation. In addition, the investigators wil test the hypothesis that the effects of exercise training associated with respiratory training on cardiovascular and pulmonary responses and skeletal muscle system may be greater than exercise training or respiratory training alone.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease Single Ventricle	Other: Physical Activity	N/A

Detailed Description

This research proposes to evaluate patients after undergoing the Fontan surgery. The investigators want to understanding exercise intolerance and they want to demonstrate the effects of exercise training after different programs of physical exercise. As well as, the quality of life.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cardiovascular, Pulmonary and Skeletal Muscle Evaluation in Patients With Univentricular Physiology in the Late Postoperative Period of the Fontan Surgery: Effects of Exercise Training

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Physical Activity 1 Aerobic Training: Aerobic training and muscle strength exercise for upper and lower limbs, 3 times a week for 4 months.	Other: Physical Activity Physical Activity, Exercise training: aerobic and respiratory exercise with POWERbreathe device Other Names: Exercise training: aerobic and respiratory exercise
Active Comparator: Physical Activity 2 Respiratory Training: muscle training using POWERbreathe device, 7 times a week, 3 series of 30 repetitions per day, for 4 months.	Other: Physical Activity Physical Activity, Exercise training: aerobic and respiratory exercise with POWERbreathe device Other Names: Exercise training: aerobic and respiratory exercise
Active Comparator: Physical Activity 3 Aerobic and Respiratory Training: Aerobic training and muscle strength exercise for upper and lower limbs, 3 times a week for 4 months and respiratory muscle training using POWERbreathe device, 7 times a week, 3 series of 30 repetitions per day, for 4 months.	Other: Physical Activity Physical Activity, Exercise training: aerobic and respiratory exercise with POWERbreathe device Other Names: Exercise training: aerobic and respiratory exercise
No Intervention: Physical Activity 4 No Physical Activity: Control group (usual care)

Outcome Measures

Primary Outcome Measures

Improvement exercise tolerance and physical capacity [Baseline and 4 months]
Change in parameters by cardiopulmonary exercise test; increase in lung volumes and capacities; improvement by neurovascular control and skeletical muscle metabolism

Other Outcome Measures

Improvement in the functional capacity post exercise training program [baseline and 4 months]
Increase at least 20% cardiopulmonary exercise test parameters: VO2 peak, oxygen pulse and VE/VCO2 slope
Improvement in pulmonary function post physical exercise program [baseline and 4 months]
Achieve at least 80% of predicted values for age at pulmonary function testing: spirometry, plethysmography, carbon monoxide diffusion capacity and maximal inspiratory pressure
Change in autonomic function post exercise training program [baseline and 4 months]
Decrease bursts/min and bursts per 100 heart beats by at least 20% from baseline by directly measured by microneurography : direct muscle sympathetic nerve activity (MSNA)
Improvement in peripheral blood flow post exercise training program [baseline and 4 months]
Increase forearm blood flow in mL/min/100mL
Change in the plasma epinephrine level post exercise training program [baseline and 4 months]
Decrease of plasma epinephrine level from baseline
Change in muscle metabolism post exercise training program [baseline and 4 months]
Increase of the amplitudes of the phosphocreatine, inorganic phosphate and ATP from baseline by 31P-MRS: Quadriceps femoral 31P-MRS

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Both gender, aged between 12 and 30 years
Patients undergoing the Fontan operation with time postoperatively ≥5 years
Clinically stable patients, no arrhythmia in the last electrocardiogram or clinical assessment
Consent by the cardiologist
Patients who voluntarily signed the consent form.

Exclusion Criteria:

Patients with hypoplastic left heart syndrome
Changes that reduce musculoskeletal walking skills
Neurological sequelae, patients with associated genetic syndrome, disturbance cognitive or psychiatric
Patients with a history of ventricular arrhythmias, cardio respiratory arrest, users of anti-arrhythmic drugs and / or underwent implantation of pacemaker
Atrial arrhythmia requiring treatment in the last 6 months
Patients with heart failure not controlled by medications and lung hypertension
Patients with protein-losing enteropathy
Severe hypoxemia (oxygen saturation <80% at rest)
Symptomatic patients with a diagnosis of diaphragmatic paresis or paralysis postoperative patients, with or without plication
Patients with moderate to severe asthma
Patients who live outside the area of Sao Paulo

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	InCor Heart Institute	Sao Paulo		Brazil	05403000

Sponsors and Collaborators

University of Sao Paulo
InCor Heart Institute
Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Study Chair: Marcelo B Jatene, MD,PhD, Heart Institute, University of Sao Paulo, Medical School
Principal Investigator: Aida LR Turquetto, PhD student, Heart Institute, University of Sao Paulo, Medical School