Congenital Heart DiseaseNCT02283255
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training
A study testing Aerobic Exercise Training, Inspiratory Muscle Training and No Exercise Training in people with Congenital Heart Disease and Single Ventricle, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Single Ventricle, Univentricular Heart
- What is being tested?
- Aerobic Exercise Training, Inspiratory Muscle Training and No Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jan 2013to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
All subjects were submitted to cardiovascular magnetic resonance, echocardiography, cardiopulmonary exercise test, complete lung function, catecholamine and B-type natriuretic peptide (BNP) plasmatic levels, microneurography, venous occlusion plethysmography, six-minute walk test, phosphorus magnetic resonance spectroscopy (31P MRS) and magnetic resonance imaging (MRI) of skeletal muscle and quality of life (QoL) using the Short Form Health Survey (SF36) in the baseline. Comparative analyzes of the different systems of the two groups were done as well as tests to identify the predictors of low functional capacity in Fontan groups (FG).
The evaluation was done at baseline in healthy subjects. And in the Fontan group at baseline and after four months of exercise training or usual care.
AET Protocol: Four-month supervised exercise training was performed in the hospital three times a week, 60-min exercise sessions (48 sessions in total). Each session consisted of 40min on a treadmill, 15 min of personal light resistance training (including chest press, squat, pull down, leg extension, shoulder press, calf raises, leg curl, and sit-ups), and 5min of cool down and stretching. The AET was individually prescribed according to their heart rate (HR) from maximal cardiopulmonary exercise testing (CPT), and patients exercised between the ventilatory threshold (VT) and respiratory compensation point (RCP). HR, systolic blood pressure, oxygen saturation, and exhaustion (i.e., Borg scale from 7 to 20) were monitored during the sessions. An exercise physiologist supervised all sessions. In the first 12 weeks, HR was maintained at T frequency. Between the 12th to 24thweek, there was a progressive increase in the effort, and HR was supported between AT and RCP. In the last 12 sessions of the program, HR was maintained close to RCP frequency.
IMT Protocol: Four months of exercise training were carried out daily, three sets of 30 repetitions using the POWERbreathe® device (POWERbreathe International Limited, Southam, UK), three sets of 30 repetitions. Maximal inspiratory pressure (MIP) measures were performed in all patients before the intervention, and patients exercised at 60% of individual MIP. Patients were instructed to inhale using diaphragm musculature, trying to expand the rib cage to avoid the use of accessory muscles, and breathing at a rate of 12 to 16 breaths/min. A nose clip was worn to ensure patients breathed exclusively through the training device. All patients had a supervised session of IMT with a physiotherapist once a week for the first two months and once every two weeks for the last two months. The load was adjusted during the supervised sessions. Patients were encouraged to maintain their habitual activities during the protocol.
- Being tested
- Aerobic Exercise Training, Inspiratory Muscle Training, No Exercise Training
- Keywords
- Fontan, Exercise, Pulmonary Function, Aerobic Capacity, Skeletal Muscle, Neurovascular control, Functional capacity
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
Also called AET
Supervised aerobic and light muscle resistance exercise training
Inspiratory Muscle TrainingOther
Also called IMT
Inspiratory muscle training with POWERbreathe device
No Exercise TrainingOther
Also called NET
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Training Group | Active comparator | Aerobic Training: Aerobic training and muscle strength exercise for upper and lower limbs, 3 times a week for 4 months. Receives: Other: Aerobic Exercise Training |
| Inspiratory Muscle Training Group | Active comparator | Respiratory Training: muscle training using POWERbreathe device, 7 times a week, 3 series of 30 repetitions per day, for 4 months. Receives: Other: Inspiratory Muscle Training |
| No Exercise Trainint Group | Active comparator | No Physical Activity: Control group (usual care) Receives: Other: No Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement exercise tolerance and physical capacity
Change in parameters by cardiopulmonary exercise test; increase in lung volumes and capacities; improvement by neurovascular control and skeletical muscle metabolism
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study start31 Jan 2013
- Primary completion30 Jan 2016
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Aida Luiza R Turquetto, University of Sao Paulo
- Investigators
- Marcelo B Jatene, MD,PhD, Study chair, Heart Institute, University of Sao Paulo, Medical SchoolAida LR Turquetto, PhD student, Principal investigator, Heart Institute, University of Sao Paulo, Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283255
- Sponsor's protocol ID
- CAAE 01998712.7.0000.0068
- Status last verified
- Dec 2022
- First submitted
- 3 Sep 2014
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ohuchi H, Ohashi H, Takasugi H, Yamada O, Yagihara T, Echigo S. Restrictive ventilatory impairment and arterial oxygenation characterize rest and exercise ventilation in patients after fontan operation. Pediatr Cardiol. 2004 Sep-Oct;25(5):513-21. doi: 10.1007/s00246-003-0652-7. Epub 2004 May 12.
PubMed 15136907Brassard P, Poirier P, Martin J, Noel M, Nadreau E, Houde C, Cloutier A, Perron J, Jobin J. Impact of exercise training on muscle function and ergoreflex in Fontan patients: a pilot study. Int J Cardiol. 2006 Feb 8;107(1):85-94. doi: 10.1016/j.ijcard.2005.02.038. Epub 2005 Jul 19.
PubMed 16046016Binotto MA, Maeda NY, Lopes AA. Altered endothelial function following the Fontan procedure. Cardiol Young. 2008 Feb;18(1):70-4. doi: 10.1017/S1047951107001680. Epub 2007 Dec 20.
PubMed 18093358Steier J, Kaul S, Seymour J, Jolley C, Rafferty G, Man W, Luo YM, Roughton M, Polkey MI, Moxham J. The value of multiple tests of respiratory muscle strength. Thorax. 2007 Nov;62(11):975-80. doi: 10.1136/thx.2006.072884. Epub 2007 Jun 8.
PubMed 17557772Anderson PA, Sleeper LA, Mahony L, Colan SD, Atz AM, Breitbart RE, Gersony WM, Gallagher D, Geva T, Margossian R, McCrindle BW, Paridon S, Schwartz M, Stylianou M, Williams RV, Clark BJ 3rd; Pediatric Heart Network Investigators. Contemporary outcomes after the Fontan procedure: a Pediatric Heart Network multicenter study. J Am Coll Cardiol. 2008 Jul 8;52(2):85-98. doi: 10.1016/j.jacc.2008.01.074.
PubMed 18598886Trojnarska O, Gwizdala A, Katarzynski S, Katarzynska A, Szyszka A, Lanocha M, Grajek S, Kramer L. Evaluation of exercise capacity with cardiopulmonary exercise test and B-type natriuretic peptide in adults with congenital heart disease. Cardiol J. 2009;16(2):133-41.
PubMed 19387960d'Udekem Y, Cheung MM, Setyapranata S, Iyengar AJ, Kelly P, Buckland N, Grigg LE, Weintraub RG, Vance A, Brizard CP, Penny DJ. How good is a good Fontan? Quality of life and exercise capacity of Fontans without arrhythmias. Ann Thorac Surg. 2009 Dec;88(6):1961-9. doi: 10.1016/j.athoracsur.2009.07.079.
PubMed 19932269Greutmann M, Le TL, Tobler D, Biaggi P, Oechslin EN, Silversides CK, Granton JT. Generalised muscle weakness in young adults with congenital heart disease. Heart. 2011 Jul;97(14):1164-8. doi: 10.1136/hrt.2010.213579. Epub 2011 Jan 21.
PubMed 21258001Driscoll DJ, Durongpisitkul K. Exercise testing after the Fontan operation. Pediatr Cardiol. 1999 Jan-Feb;20(1):57-9; discussion 60. doi: 10.1007/s002469900397. No abstract available.
PubMed 9861079Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
PubMed 10412550McCall R, Humphrey R. Exercise training in a young adult late after a fontan procedure to repair single ventricle physiology. J Cardiopulm Rehabil. 2001 Jul-Aug;21(4):227-30. doi: 10.1097/00008483-200107000-00007. No abstract available.
PubMed 11508184Minamisawa S, Nakazawa M, Momma K, Imai Y, Satomi G. Effect of aerobic training on exercise performance in patients after the Fontan operation. Am J Cardiol. 2001 Sep 15;88(6):695-8. doi: 10.1016/s0002-9149(01)01822-7. No abstract available.
PubMed 11564403Negrao CE, Rondon MU, Tinucci T, Alves MJ, Roveda F, Braga AM, Reis SF, Nastari L, Barretto AC, Krieger EM, Middlekauff HR. Abnormal neurovascular control during exercise is linked to heart failure severity. Am J Physiol Heart Circ Physiol. 2001 Mar;280(3):H1286-92. doi: 10.1152/ajpheart.2001.280.3.H1286.
PubMed 11179075American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Larsson ES, Eriksson BO, Sixt R. Decreased lung function and exercise capacity in Fontan patients. A long-term follow-up. Scand Cardiovasc J. 2003;37(1):58-63. doi: 10.1080/14017430310007045.
PubMed 12745804
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02283255
- Acronym / sponsor ID
- CAAE 01998712.7.0000.0068
- Keywords
- Fontan, Exercise, Pulmonary Function, Aerobic Capacity, Skeletal Muscle, Neurovascular control, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 31 Jan 2013 (actual)
- Primary completion
- 30 Jan 2016 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All subjects were submitted to cardiovascular magnetic resonance, echocardiography, cardiopulmonary exercise test, complete lung function, catecholamine and B-type natriuretic peptide (BNP) plasmatic levels, microneurography, venous occlusion plethysmography, six-minute walk test, phosphorus magnetic resonance spectroscopy (31P MRS) and magnetic resonance imaging (MRI) of skeletal muscle and quality of life (QoL) using the Short Form Health Survey (SF36) in the baseline. Comparative analyzes of the different systems of the two groups were done as well as tests to identify the predictors of low functional capacity in Fontan groups (FG).
The evaluation was done at baseline in healthy subjects. And in the Fontan group at baseline and after four months of exercise training or usual care.
AET Protocol: Four-month supervised exercise training was performed in the hospital three times a week, 60-min exercise sessions (48 sessions in total). Each session consisted of 40min on a treadmill, 15 min of personal light resistance training (including chest press, squat, pull down, leg extension, shoulder press, calf raises, leg curl, and sit-ups), and 5min of cool down and stretching. The AET was individually prescribed according to their heart rate (HR) from maximal cardiopulmonary exercise testing (CPT), and patients exercised between the ventilatory threshold (VT) and respiratory compensation point (RCP). HR, systolic blood pressure, oxygen saturation, and exhaustion (i.e., Borg scale from 7 to 20) were monitored during the sessions. An exercise physiologist supervised all sessions. In the first 12 weeks, HR was maintained at T frequency. Between the 12th to 24thweek, there was a progressive increase in the effort, and HR was supported between AT and RCP. In the last 12 sessions of the program, HR was maintained close to RCP frequency.
IMT Protocol: Four months of exercise training were carried out daily, three sets of 30 repetitions using the POWERbreathe® device (POWERbreathe International Limited, Southam, UK), three sets of 30 repetitions. Maximal inspiratory pressure (MIP) measures were performed in all patients before the intervention, and patients exercised at 60% of individual MIP. Patients were instructed to inhale using diaphragm musculature, trying to expand the rib cage to avoid the use of accessory muscles, and breathing at a rate of 12 to 16 breaths/min. A nose clip was worn to ensure patients breathed exclusively through the training device. All patients had a supervised session of IMT with a physiotherapist once a week for the first two months and once every two weeks for the last two months. The load was adjusted during the supervised sessions. Patients were encouraged to maintain their habitual activities during the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Training Group | Active comparator | Other: Aerobic Exercise TrainingAerobic Training: Aerobic training and muscle strength exercise for upper and lower limbs, 3 times a week for 4 months. |
| Inspiratory Muscle Training Group | Active comparator | Other: Inspiratory Muscle TrainingRespiratory Training: muscle training using POWERbreathe device, 7 times a week, 3 series of 30 repetitions per day, for 4 months. |
| No Exercise Trainint Group | Active comparator | Other: No Exercise TrainingNo Physical Activity: Control group (usual care) |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingAlso: AETSupervised aerobic and light muscle resistance exercise training | Other | Aerobic Exercise Training Group |
| Inspiratory Muscle TrainingAlso: IMTInspiratory muscle training with POWERbreathe device | Other | Inspiratory Muscle Training Group |
| No Exercise TrainingAlso: NETUsual care | Other | No Exercise Trainint Group |
Primary outcome
Improvement exercise tolerance and physical capacity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 15136907Ohuchi H, Ohashi H, Takasugi H, Yamada O, Yagihara T, Echigo S. Restrictive ventilatory impairment and arterial oxygenation characterize rest and exercise ventilation in patients after fontan operation. Pediatr Cardiol. 2004 Sep-Oct;25(5):513-21. doi: 10.1007/s00246-003-0652-7. Epub 2004 May 12.
- Background: PubMed 16046016Brassard P, Poirier P, Martin J, Noel M, Nadreau E, Houde C, Cloutier A, Perron J, Jobin J. Impact of exercise training on muscle function and ergoreflex in Fontan patients: a pilot study. Int J Cardiol. 2006 Feb 8;107(1):85-94. doi: 10.1016/j.ijcard.2005.02.038. Epub 2005 Jul 19.
- Background: PubMed 18093358Binotto MA, Maeda NY, Lopes AA. Altered endothelial function following the Fontan procedure. Cardiol Young. 2008 Feb;18(1):70-4. doi: 10.1017/S1047951107001680. Epub 2007 Dec 20.
- Background: PubMed 17557772Steier J, Kaul S, Seymour J, Jolley C, Rafferty G, Man W, Luo YM, Roughton M, Polkey MI, Moxham J. The value of multiple tests of respiratory muscle strength. Thorax. 2007 Nov;62(11):975-80. doi: 10.1136/thx.2006.072884. Epub 2007 Jun 8.
- Background: PubMed 18598886Anderson PA, Sleeper LA, Mahony L, Colan SD, Atz AM, Breitbart RE, Gersony WM, Gallagher D, Geva T, Margossian R, McCrindle BW, Paridon S, Schwartz M, Stylianou M, Williams RV, Clark BJ 3rd; Pediatric Heart Network Investigators. Contemporary outcomes after the Fontan procedure: a Pediatric Heart Network multicenter study. J Am Coll Cardiol. 2008 Jul 8;52(2):85-98. doi: 10.1016/j.jacc.2008.01.074.
- Background: PubMed 19387960Trojnarska O, Gwizdala A, Katarzynski S, Katarzynska A, Szyszka A, Lanocha M, Grajek S, Kramer L. Evaluation of exercise capacity with cardiopulmonary exercise test and B-type natriuretic peptide in adults with congenital heart disease. Cardiol J. 2009;16(2):133-41.
- Background: PubMed 19932269d'Udekem Y, Cheung MM, Setyapranata S, Iyengar AJ, Kelly P, Buckland N, Grigg LE, Weintraub RG, Vance A, Brizard CP, Penny DJ. How good is a good Fontan? Quality of life and exercise capacity of Fontans without arrhythmias. Ann Thorac Surg. 2009 Dec;88(6):1961-9. doi: 10.1016/j.athoracsur.2009.07.079.
- Background: PubMed 21258001Greutmann M, Le TL, Tobler D, Biaggi P, Oechslin EN, Silversides CK, Granton JT. Generalised muscle weakness in young adults with congenital heart disease. Heart. 2011 Jul;97(14):1164-8. doi: 10.1136/hrt.2010.213579. Epub 2011 Jan 21.
- Results publication: PubMed 9861079Driscoll DJ, Durongpisitkul K. Exercise testing after the Fontan operation. Pediatr Cardiol. 1999 Jan-Feb;20(1):57-9; discussion 60. doi: 10.1007/s002469900397. No abstract available.
- Results publication: PubMed 10412550Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
- Results publication: PubMed 11508184McCall R, Humphrey R. Exercise training in a young adult late after a fontan procedure to repair single ventricle physiology. J Cardiopulm Rehabil. 2001 Jul-Aug;21(4):227-30. doi: 10.1097/00008483-200107000-00007. No abstract available.
- Results publication: PubMed 11564403Minamisawa S, Nakazawa M, Momma K, Imai Y, Satomi G. Effect of aerobic training on exercise performance in patients after the Fontan operation. Am J Cardiol. 2001 Sep 15;88(6):695-8. doi: 10.1016/s0002-9149(01)01822-7. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo B Jatene, MD,PhD study chair
Heart Institute, University of Sao Paulo, Medical School
Aida LR Turquetto, PhD student principal investigator
Heart Institute, University of Sao Paulo, Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training, Inspiratory Muscle Training and No Exercise Training in people with Congenital Heart Disease and Single Ventricle, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement exercise tolerance and physical capacity (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02283255, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.