Univentricular HeartNCT05934578
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
A study testing Exercise training in people with Univentricular Heart and Congenital Heart Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Univentricular Heart, Congenital Heart Disease, Lymphatic Abnormalities
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Sep 2022to 22 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fontan circulation
- Age above 18 years
- Agreeing to participate in the study and signing the informed consent form.
Who cannot join
- Motor alterations make it impossible to perform the cardiopulmonary test
- Mental illness
- Syndromes.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coracao, Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403900
About this study
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)
Read the 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).
- Conditions
- Univentricular Heart, Congenital Heart Disease, Lymphatic Abnormalities, Functional Capacity, Exercise Training, Quality of Life
- Being tested
- Exercise training
- Keywords
- Lymphatic dysfunction, Near-Infrared Fluorescence Imaging, Fontan circulation, Plethysmography, Functional capacity, Aerobic exercise, Cardiac rehabilitation, Capillary filtration, Exercise training
- Medical subject headings
- Univentricular Heart, Heart Defects, Congenital, Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Aerobic and light muscle resistance exercise by online cardiovascular rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Fontan Group - Exercise Training | Experimental | Online rehabilitation: 36 sessions of aerobic exercise training for two months Receives: Other: Exercise training |
| Fontan Control Group - No Exercise Training | No intervention | Patients will not participate in the exercise program and will continue with their usual routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Peripheral Lymphatic Function Using Near-Infrared Fluorescence Imaging: Contraction Frequency Analysis over a 6-Minute Baseline
Change in peripheral lymphatic function will be evaluated by Near-Infrared Fluorescence Imaging expressed by Contraction frequency (minute-1). A contraction was defined as a visual validation of a packet moving through a Regions of interests (ROI) placed on each measurable vessel and/or increase in the intensity signal displayed in the LabVIEW program. Contractions were counted over the obtained 6-min baseline.
Measured: After 8 weeks of exercise training program or usual rotine
Quantifying Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Assessment of Packet Velocity (cm/s) between ROIs.
Change in peripheral lymphatic function will be evaluated by Near-Infrared Fluorescence Imaging expressed by Packet velocity (cm/s). Two ROIs were placed 5-10 cm apart on each vessel in the baseline sequence. Packages moving continuously through both ROIs were included in the calculations. The distance between the two ROIs was divided by the time difference between the packet passing each ROI.
Measured: After 8 weeks of exercise training program or usual rotine
Assessing Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Determination of Pumping Pressure (mmHg).
Change in peripheral lymphatic function will be evaluated by Near-Infrared Fluorescence Imaging expressed by Pumping pressure (mmHg). Pumping pressure was determined by occluding lymphatic vessels using a Hokanson sphygmomanometer cuff (Marcom Medical Denmark). A tourniquet was placed distally to the sphygmomanometer cuff to prevent any lymphatic flow and allowing manual emptying of the lymphatic vessels under and above the cuff, which be inflated to 80 mm Hg (Hokanson E20 Rapid cuff inflator, Hokanson AG101 air source, SC10 cuff; Marcom Medical, Denmark) and the tourniquet was released allowing lymph flow up to the distal border of the cuff. Then, the cuff pressure was reduced with 5 mm Hg every 5th min until the fluorescent dye passed under the inflated cuff at which point the reached pressure level was noted as the pumping pressure.
Measured: After 8 weeks of exercise training program or usual rotine
Secondary outcomes (4)
Assessment of Capillary Filtration Rate Using Venous Occlusion Plethysmography
The capillary filtration rate (CFR) can be evaluated using venous occlusion plethysmography. CFR is measured using a strain gauge plethysmography setup (Hokanson EC6 and E20; Marcom Medical, Denmark) connected to a PC via an analog-to-digital converter (ADInstruments, UK). The measurements were analyzed using Labchart 7 software.
The procedure involves placing a cuff around the right calf, conducting venous congestion applying pressures ranging from 20 to 70 mm Hg each 3 min. A strain gauge was placed on the widest circumference of the calf to record an increase in volume.
The CFR was measured as the slope of the time-volume change (%) curve at a steady state at the end of each pressure phase. Measurements were taken at 10 mm Hg pressure intervals from 20 to 70 mm Hg.
Measured: After 8 weeks of exercise training program or usual rotine
Functional capacity assessment 1
Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 (mL/kg/min). After the training program, an increase in the peak VO2 value between 5 to 10% is expected in relation to the baseline value
Measured: After 8 weeks of exercise training program or usual rotine
"Functional Capacity Assessment through Cardiopulmonary Exercise Test: Predicted Peak VO2 (%) as an Indicator of Training Program Effectiveness
Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Predicted Peak VO2 (%). After the training program, an increase in the predicted peak VO2 value between 5 to 10% is expected in relation to the baseline value.
Measured: After 8 weeks of exercise training program or usual rotine
Assessment of Quality of Life Using Short Form 36 Questionnaire: A Multi-Domain Analysis with Scores Ranging from 0 to 100
Changes in quality of life will be measure by Short Form 36 questionnaire by 8 domains: Physical functioning, Physical role functioning, body pain, general health, vitality, social functioning, emotional role functioning, mental health. The quality of life classification for each domain is typically measured on a scale of 0 to 100, where a score close to 100 indicates a higher or superior quality of life, while a score near 0 suggests a lower or poorer quality of life.
Measured: After 8 weeks of exercise training program or usual rotine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start26 Sep 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Univentricular HeartStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A longitudinal clinical trial, controlled and no-randomized. Intervention: Exercise (aerobic and light muscle resistance exercise)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 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, Copenhagen University Hospital, Denmark, University of Aarhus
- Responsible party
- Principal investigator, Aida Luiza R Turquetto, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934578
- Sponsor's protocol ID
- CAAE 61404222.6.0000.0068
- Status last verified
- Jul 2023
- First submitted
- 17 Nov 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
- ClinicalTrials.gov ID
- NCT05934578
- Acronym / sponsor ID
- CAAE 61404222.6.0000.0068
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Copenhagen University Hospital, Denmark, University of Aarhus
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 7 Jul 2023 (actual)
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A longitudinal clinical trial, controlled and no-randomized. Intervention: Exercise (aerobic and light muscle resistance exercise)
| Arm | Type | Receives |
|---|---|---|
| Fontan Group - Exercise Training | Experimental | Other: Exercise trainingOnline rehabilitation: 36 sessions of aerobic exercise training for two months |
| Fontan Control Group - No Exercise Training | No intervention | –Patients will not participate in the exercise program and will continue with their usual routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fontan circulation
- Age above 18 years
- Agreeing to participate in the study and signing the informed consent form.
Key exclusion criteria (3 listed)
- Motor alterations make it impossible to perform the cardiopulmonary test
- Mental illness
- Syndromes.
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 |
|---|---|---|
| Exercise trainingAerobic and light muscle resistance exercise by online cardiovascular rehabilitation | Other | Fontan Group - Exercise Training |
Primary outcome
Assessing Peripheral Lymphatic Function Using Near-Infrared Fluorescence Imaging: Contraction Frequency Analysis over a 6-Minute Baseline
Time frame: After 8 weeks of exercise training program or usual rotine
Change in peripheral lymphatic function will be evaluated by Near-Infrared Fluorescence Imaging expressed by Contraction frequency (minute-1). A contraction was defined as a visual validation of a packet moving through a Regions of interests (ROI) placed on each measurable vessel and/or increase in the intensity signal displayed in the LabVIEW program. Contractions were counted over the obtained 6-min baseline.
Quantifying Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Assessment of Packet Velocity (cm/s) between ROIs.
Time frame: After 8 weeks of exercise training program or usual rotine
Change in peripheral lymphatic function will be evaluated by Near-Infrared Fluorescence Imaging expressed by Packet velocity (cm/s). Two ROIs were placed 5-10 cm apart on each vessel in the baseline sequence. Packages moving continuously through both ROIs were included in the calculations. The distance between the two ROIs was divided by the time difference between the packet passing each ROI.
Assessing Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Determination of Pumping Pressure (mmHg).
Time frame: After 8 weeks of exercise training program or usual rotine
Change in peripheral lymphatic function will be evaluated by Near-Infrared Fluorescence Imaging expressed by Pumping pressure (mmHg). Pumping pressure was determined by occluding lymphatic vessels using a Hokanson sphygmomanometer cuff (Marcom Medical Denmark). A tourniquet was placed distally to the sphygmomanometer cuff to prevent any lymphatic flow and allowing manual emptying of the lymphatic vessels under and above the cuff, which be inflated to 80 mm Hg (Hokanson E20 Rapid cuff inflator, Hokanson AG101 air source, SC10 cuff; Marcom Medical, Denmark) and the tourniquet was released allowing lymph flow up to the distal border of the cuff. Then, the cuff pressure was reduced with 5 mm Hg every 5th min until the fluorescent dye passed under the inflated cuff at which point the reached pressure level was noted as the pumping pressure.
4 secondary outcomes
Assessment of Capillary Filtration Rate Using Venous Occlusion Plethysmography
Time frame: After 8 weeks of exercise training program or usual rotine
Functional capacity assessment 1
Time frame: After 8 weeks of exercise training program or usual rotine
"Functional Capacity Assessment through Cardiopulmonary Exercise Test: Predicted Peak VO2 (%) as an Indicator of Training Program Effectiveness
Time frame: After 8 weeks of exercise training program or usual rotine
Assessment of Quality of Life Using Short Form 36 Questionnaire: A Multi-Domain Analysis with Scores Ranging from 0 to 100
Time frame: After 8 weeks of exercise training program or usual rotine
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 28 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Univentricular Heart and Congenital Heart Disease, 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 3 inclusion and 3 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 28 Jul 2023. 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?
Assessing Peripheral Lymphatic Function Using Near-Infrared Fluorescence Imaging: Contraction Frequency Analysis over a 6-Minute Baseline (time frame: After 8 weeks of exercise training program or usual rotine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2023.