deltatrials
Completed NA INTERVENTIONAL 3-arm NCT02283255

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

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

Sponsor: Fundação de Amparo à Pesquisa do Estado de São Paulo

Updated 9 times since 2017 Last updated: Dec 3, 2022 Started: Jan 31, 2013 Primary completion: Jan 30, 2016 Completion: Oct 30, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Congenital Heart Disease and Single Ventricle and is currently completed. Fundação de Amparo à Pesquisa do Estado de São Paulo leads this study, which shows 9 recorded versions since 2013 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotUnknown Status~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2025 — Present [monthly]

    Completed NA

  3. Sep 2024 — Sep 2025 [monthly]

    Completed NA

  4. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  5. Jan 2023 — Jul 2024 [monthly]

    Completed NA

Show 4 earlier versions
  1. Dec 2022 — Jan 2023 [monthly]

    Completed NA

    Status: Unknown StatusCompleted

  2. Jan 2021 — Dec 2022 [monthly]

    Unknown Status NA

  3. Jun 2018 — Jan 2021 [monthly]

    Unknown Status NA

  4. Jan 2017 — Jun 2018 [monthly]

    Unknown Status NA

    First recorded

Jan 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • University of Sao Paulo
Data source: University of Sao Paulo

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations