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Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training

Primary Purpose

Univentricular Heart, Congenital Heart Disease, Lymphatic Abnormalities

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Univentricular Heart focused on measuring Lymphatic dysfunction, Near-Infrared Fluorescence Imaging, Fontan circulation, Plethysmography, Functional capacity, Aerobic exercise, Cardiac rehabilitation, Capillary filtration, Exercise training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Fontan circulation Age above 18 years Agreeing to participate in the study and signing the informed consent form. Exclusion Criteria: Motor alterations make it impossible to perform the cardiopulmonary test Mental illness Syndromes.

Sites / Locations

  • Instituto do Coracao, Faculdade de Medicina da Universidade de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fontan Group - Exercise Training

Fontan Control Group - No Exercise Training

Arm Description

Online rehabilitation: 36 sessions of aerobic exercise training for two months

Patients will not participate in the exercise program and will continue with their usual routine.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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
"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.
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.

Full Information

First Posted
November 17, 2022
Last Updated
July 25, 2023
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Copenhagen University Hospital, Denmark, University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05934578
Brief Title
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
Official Title
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Copenhagen University Hospital, Denmark, University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A longitudinal clinical trial, controlled and no-randomized. Intervention: Exercise (aerobic and light muscle resistance exercise)
Masking
Outcomes Assessor
Masking Description
Two groups, one of them (10) will be submitted to an exercise program, and the other (10) will be maintained usual care.
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fontan Group - Exercise Training
Arm Type
Experimental
Arm Description
Online rehabilitation: 36 sessions of aerobic exercise training for two months
Arm Title
Fontan Control Group - No Exercise Training
Arm Type
No Intervention
Arm Description
Patients will not participate in the exercise program and will continue with their usual routine.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Aerobic and light muscle resistance exercise by online cardiovascular rehabilitation
Primary Outcome Measure Information:
Title
Assessing Peripheral Lymphatic Function Using Near-Infrared Fluorescence Imaging: Contraction Frequency Analysis over a 6-Minute Baseline
Description
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.
Time Frame
After 8 weeks of exercise training program or usual rotine
Title
Quantifying Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Assessment of Packet Velocity (cm/s) between ROIs.
Description
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.
Time Frame
After 8 weeks of exercise training program or usual rotine
Title
Assessing Peripheral Lymphatic Function through Near-Infrared Fluorescence Imaging: Determination of Pumping Pressure (mmHg).
Description
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.
Time Frame
After 8 weeks of exercise training program or usual rotine
Secondary Outcome Measure Information:
Title
Assessment of Capillary Filtration Rate Using Venous Occlusion Plethysmography
Description
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.
Time Frame
After 8 weeks of exercise training program or usual rotine
Title
Functional capacity assessment 1
Description
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
Time Frame
After 8 weeks of exercise training program or usual rotine
Title
"Functional Capacity Assessment through Cardiopulmonary Exercise Test: Predicted Peak VO2 (%) as an Indicator of Training Program Effectiveness
Description
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.
Time Frame
After 8 weeks of exercise training program or usual rotine
Title
Assessment of Quality of Life Using Short Form 36 Questionnaire: A Multi-Domain Analysis with Scores Ranging from 0 to 100
Description
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.
Time Frame
After 8 weeks of exercise training program or usual rotine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fontan circulation Age above 18 years Agreeing to participate in the study and signing the informed consent form. Exclusion Criteria: Motor alterations make it impossible to perform the cardiopulmonary test Mental illness Syndromes.
Facility Information:
Facility Name
Instituto do Coracao, Faculdade de Medicina da Universidade de Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403900
Country
Brazil

12. IPD Sharing Statement

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