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| Name | Class |
|---|---|
| Instituto Mexicano de Investigaciones Nefrológicas | UNKNOWN |
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Introduction: Cardiovascular disease is the leading cause of morbidity and mortality in patients undergoing hemodialysis, largely due to structural cardiac changes associated with left ventricular diastolic dysfunction. In addition, this population has a high prevalence of sedentary behavior, which has been associated with increased mortality. Recent studies in patients with chronic kidney disease have shown that structured exercise interventions improve several parameters related to cardiovascular health.
Objectives: To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function.
Materials and Methods: This will be a quasi-experimental before-and-after study conducted in two phases. During the first phase (control), prevalent hemodialysis patients will receive standard treatment for 16 weeks. Transthoracic echocardiography will be performed at baseline and repeated at the end of this phase to assess left ventricular diastolic function parameters. During the second phase (intradialytic exercise), participants will undergo a 16-week supervised and prescribed intradialytic aerobic exercise program consisting of intradialytic cycling. Exercise intensity will be individualized according to cardiopulmonary exercise testing (CPET), which will be performed at the beginning and end of this phase. A final echocardiogram will be obtained at the end of the intervention phase. In addition, a 6-minute walk test and a validated physical activity questionnaire will be administered monthly throughout both phases of the study.
Left Ventricular Diastolic Function worsens during the hemodialysis session mainly due to preload effects. However, studies in patients with advanced CKD (pre-dialysis) have shown benefits in diastolic function when subjected to exercise programs. Based on this, implementing a standardized and protocolized exercise regimen during the hemodialysis session could provide cardiovascular benefits, specifically in terms of improving left ventricular diastolic function in this population.
The implementation of intradialytic exercise in the hemodialysis unit of our Institute began in 1994. However, there is no standardized or systematic process for intradialytic exercise.
This leads us to ask the following question: What is the effect of performing systematic intradialytic exercise on the echocardiographic parameters of left ventricular diastolic function in hemodialysis patients?
Methodology
Study Design:
Study Population Description:
The target population is patients with chronic kidney disease who are currently receiving hemodialysis at the National Institute of Cardiology (prevalent hemodialysis patients).
Eligible Population:
Patients with chronic kidney disease, prevalent in hemodialysis, who are treated in the hemodialysis unit at the National Institute of Cardiology, with left ventricular diastolic function determined by echocardiographic measurement within a 6-month period from September 2023 to September 2024.
Once the inclusion criteria are met, a baseline transthoracic echocardiogram will be performed to determine and record the parameters that evaluate left ventricular diastolic function. If the patient presents any degree of diastolic dysfunction, the study will begin with a 16-week hemodialysis period without exercise. All echocardiograms will be performed before the first dialysis session of the week (Monday or Tuesday according to the patient's session schedule). At the end of the 16 weeks, a final transthoracic echocardiogram will be performed. The second phase of the study, which consists of hemodialysis with intradialytic exercise for 16 weeks, will then begin, and at the end of this period, another final transthoracic echocardiogram will be performed to determine diastolic function parameters. All echocardiograms will be performed before the first dialysis session of the week (Monday or Tuesday according to the patient's session schedule).
Evaluation of Intradialytic Exercise:
The prescription of intradialytic exercise will be based on the FITT-VP protocol, validated by the American College of Sports Medicine, which consists of the following points:
Based on this, a cardiopulmonary exercise test will be conducted by a sports medicine expert for all patients. Based on the results and according to Skinner's three-phase model, the prescribed workload will be determined by the first ventilatory threshold (VT1), which lies between training zones 1 and 2. Adjustments will be made according to the FITT-VP points as follows:
Frequency: Frequency: 3 times a week during the hemodialysis session (all patients)
Intensity: Low (no resistance), maintaining the VT1 watts throughout the session.
Time: Initially 45 minutes, increasing by 5 minutes each week, reaching 1 hour 30 minutes of exercise at the end of the study phase.
Type: Aerobic (stationary cycling).
Volume: Continuous pedaling during the hemodialysis session with work monitored in watts using power meters.
Progression: Progress will be recorded during the intradialytic exercise period.
Intradialytic exercise will be performed with a stationary bicycle model Urban fit PRO SH-612. Power meters (Favero Assioma UNO) will be inserted into the pedals and connected to a cycle computer (iGPSPORT BSC100S) to measure the workload in watts. The intradialytic exercise program will consist of pedaling during the hemodialysis session, with heart rate reserve monitored using the modified Karvonen method ((HRmax-HRrest)×(40-80%)+ HRrest) and Borg's Rating of Perceived Exertion Scale. A record will be kept for each session. Exercise prescription will be supervised by a sports medicine specialist, along with two medical interns trained in cardiopulmonary exercise testing, who will be responsible for registering and supervising the intradialytic exercise program.
Evaluation of Diastolic Function:
Diastolic function will be measured based on the international recommendations of the American and European Societies of Echocardiography published in 2016. The two-dimensional echocardiography study will be performed by two experienced cardiologists with current certification in echocardiography, using the Vivid Q GE ultrasound machine with a 3.5 MHz transducer. The following measurements will be taken:
Based on these parameters, measurements will be categorized into grades of diastolic dysfunction (1, 2, 3, or indeterminate) according to current guidelines for patients with either reduced or preserved LVEF as appropriate. Left atrial strain will be measured using tissue Doppler in an apical 4-chamber view with the speckle tracking method.
6-Minute Walk Test: The test will be conducted on the first day of the hemodialysis session (Monday or Tuesday) before the session, every 4 weeks. The test will be performed based on the guidelines of the American and European Thoracic Societies by two medical interns trained to administer the test.
General Practice Physical Activity Questionnaire (GPPAQ):
The GPPAQ questionnaire will be administered to each patient at the beginning and every 4 weeks thereafter, on the same day and before the 6-minute walk test. The GPPAQ is a self-administered questionnaire for adults consisting of 3 questions. The first question measures the type and amount of physical activity (PA) at work, the second asks about the time spent on different types of PA during the last week, and the third asks about the usual walking pace. The scoring system classifies patients into 4 levels of PA: inactive (sedentary work and no physical exercise or cycling), moderately inactive (sedentary work and <1 hour of physical exercise or cycling, or standing work without physical exercise or cycling), moderately active (sedentary work and 1-2.9 hours/week of physical exercise or cycling, or standing work and <1 hour/week of physical exercise or cycling, or physically active work without physical exercise or cycling), and active (sedentary work and ≥3 hours/week of physical exercise or cycling, or standing work and 1-2.9 hours/week of physical exercise or cycling, or physically active work and <1 hour of physical exercise or cycling, or work with vigorous PA).
Adverse Event Monitoring Adverse events will be monitored exclusively during the Intradialytic Exercise Phase (Intervention Period, 16 weeks). No exercise-related adverse events are expected during the Control Phase, as no exercise will be performed during that period. Arm for adverse event assessment: Intervention Period (Intradialytic Exercise). Adverse events during exercise, such as transient muscle fatigue or mild hemodynamic changes, will be recorded and classified. Any adverse event requiring session discontinuation will be documented and reported.
Ethics The study protocol was approved by the local Research and Ethics Committees under approval number PT 23-1378. This study was registered at ClinicalTrials.gov (NCT06584734). Written informed consent was obtained from all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevalent patients in hemodiafiltration | Other | Prevalent patients having hemodiafiltration sessions 3 times a week, they used to do intradialytic exercise but this exercise was neither measured, quantified, or supervised, so they were withdrawn from this exercise for 16 weeks and after this time, 16 weeks of structured, measured and supervised intradialytic exercise was introduced. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not exercise | Other | Patients were instructed to discontinue any unstructured exercise previously performed during their hemodiafiltration sessions for 16 weeks. Hemodiafiltration sessions continued unchanged according to the center's standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Diastolic Function Category | Classification of left ventricular diastolic function into ordinal grades based on the 2016 ASE/EACVI guidelines. Classification is determined by integrating E/A ratio, average E/e' ratio, indexed left atrial volume (LAVi), and tricuspid regurgitation (TR) velocity. Grade 1 (mild, impaired relaxation) is the least severe; Grade 2 (moderate, pseudonormal filling) represents intermediate severity; Grade 3 (severe, restrictive filling) is the most severe. Grading criteria: Grade 1 (mild - impaired relaxation): E/A < 0.8, average E/e' ≤ 14, LAVi ≤ 34 ml/m², TR velocity ≤ 2.8 m/s; fewer than 2 positive criteria. Grade 2 (moderate - pseudonormal filling): E/A 0.8-2.0, with ≥ 2 of the following positive: average E/e' > 14, LAVi > 34 ml/m², TR velocity > 2.8 m/s. Grade 3 (severe - restrictive filling): E/A > 2.0, or E/A 0.8-2.0 with all three criteria positive. | 16 weeks (end of control period) and 32 weeks (end of intervention) |
| Left Atrial Reservoir Strain (LASr) | Peak longitudinal deformation of the left atrium during the reservoir phase measured by 2D speckle tracking echocardiography. Expressed as a percentage (%). Higher values indicate better left atrial reservoir function and, indirectly, less elevation in left ventricular filling pressures. | 16 weeks (end of control period) and 32 weeks (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Global Longitudinal Strain (GLS) | Assessment of myocardial deformation using 2D speckle tracking echocardiography. Values are expressed as a negative percentage (%); more negative values indicate better longitudinal contraction (e.g., -17.4% is better than -15.5%) | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cardiología Ignacio Chávez | Mexico City | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27648403 | Background | Cusumano AM, Rosa-Diez GJ, Gonzalez-Bedat MC. Latin American Dialysis and Transplant Registry: Experience and contributions to end-stage renal disease epidemiology. World J Nephrol. 2016 Sep 6;5(5):389-97. doi: 10.5527/wjn.v5.i5.389. | |
| 35368596 | Background | Vasquez-Jimenez E, Madero M. Global Dialysis Perspective: Mexico. Kidney360. 2020 Apr 20;1(6):534-537. doi: 10.34067/KID.0000912020. eCollection 2020 Jun 25. No abstract available. |
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Participants were screened for a baseline echocardiographic window adequate for diastolic function measurement and their physical ability to perform stationary cycling during hemodialysis. Patients were excluded if they experienced a major cardiovascular event or decompensated heart failure in the 3 months prior to enrollment
The target population consisted on prevalent chronic kidney disease patients treated in the hemodialysis center at the National Institute of Cardiology between September 2023 and September 2024
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevalent Patients in Hemodiafiltration | Prevalent patients having hemodiafiltration sessions 3 times a week, they used to do intradialytic exercise but this exercise was neither measured, quantified, or supervised, so they were withdrawn from this exercise for 16 weeks and after this time, 16 weeks of structured, measured and supervised intradialytic exercise was introduced. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 1. Control Phase (Rest) - 16 weeks |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2024 |
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Echocardiographic image acquisition and analysis were performed by echocardiographers blinded to the study phase (baseline, control, and intervention).
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| Exercise during hemodiafiltration session | Other | A 16 weeks of Intradialytic exercise program that is performed using cycle ergometers during the hemodiafiltration session. Exercise intensity is quantified in watts using power meters and is individualized according to each participant's performance on cardiopulmonary exercise testing (CPET). |
|
|
| Automated Left Ventricular Ejection Fraction (AutoLVEF) | Automated left ventricular ejection fraction (%), calculated using automated contour detection software applied to 2D echocardiographic images. Represents the proportion of blood ejected from the left ventricle with each heartbeat. Higher values indicate better left ventricular systolic function; values >= 52% are considered within normal range. | 16 weeks (end of control period) and 32 weeks (end of intervention) |
| Tricuspid Annular Plane Systolic Excursion (TAPSE) | Tricuspid annular plane systolic excursion (TAPSE), measured in millimeters (mm) by M-mode echocardiography at the lateral tricuspid annulus. Reflects right ventricular longitudinal systolic function. Higher values indicate better right ventricular function; values >= 17 mm are considered within normal range. | 16 weeks (end of control period) and 32 weeks (end of intervention) |
| Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' Ratio) | Non-invasive estimate of left ventricular filling pressure calculated as the ratio of early diastolic mitral inflow velocity (E wave, pulsed-wave Doppler) to the average of septal and lateral mitral annular early diastolic velocities (e', tissue Doppler imaging). Higher values indicate elevated filling pressures. | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
| Mitral Inflow E/A Ratio | Ratio of early diastolic (E wave) to late diastolic (A wave) mitral inflow velocities measured by pulsed-wave Doppler echocardiography with the sample volume placed at the mitral valve leaflet tips, apical four-chamber view. Reflects left ventricular relaxation and filling patterns. | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
| Left Atrial Volume Index (LAVi) | Left atrial volume indexed to body surface area (ml/m^2) measured by the biplane Simpson method using apical four-chamber and two-chamber views. Reflects left atrial structural remodeling as a marker of chronic elevation in left ventricular filling pressures. Lower values indicate less atrial remodeling and are associated with better diastolic function; values <= 34 ml/m2 are within the normal range per ASE 2016 guidelines. | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
| Tricuspid Regurgitation Velocity | Peak tricuspid regurgitation velocity (cm/s) assessed by continuous-wave Doppler echocardiography, used to estimate right ventricular systolic pressure and pulmonary artery pressure per the 2016 ASE/EACVI diastolic function guidelines. Lower values are associated with lower estimated pulmonary pressures and less severe diastolic dysfunction; values <= 2.8 m/s are within the normal range. | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
| Physical Activity Level (GPPAQ) | General Practice Physical Activity Questionnaire. Self-administered questionnaire for adults consisting of 3 questions assessing type and amount of physical activity at work, during leisure time, and usual walking pace. Classifies patients into 4 levels: Inactive, Moderately Inactive, Moderately Active, and Active. Higher activity levels represent better physical activity status; Active is the most favorable and Inactive is the least favorable category. | 16 weeks (end of control period), and 32 weeks (end of intervention) |
| Distance Covered in the Six-Minute Walk Test (6MWT) | Total distance in meters (m) that a patient can quickly walk on a flat, hard surface in a period of 6 minutes based on the guidelines of the American and European Thoracic Societies by two medical interns, who are trained to perform the test. It assesses functional capacity and response to the exercise intervention. Greater distances indicate better functional exercise capacity. | 16 weeks (end of control period) and 32 weeks (end of intervention) |
| Peak Workload (Maximal Power Output) | Peak workload (maximal power output) is defined as the highest power output (in watts) achieved during a symptom-limited incremental CPET on a cycle ergometer, corresponding to the last fully completed workload stage or the highest workload maintained for ≥30 seconds. Higher values indicate greater maximal aerobic exercise capacity. | 16 weeks (end of control period), and 32 weeks (end of intervention) |
| Workload at First Ventilatory Threshold (VT1) | Power output (watts) achieved during a cardiopulmonary exercise test (CPET) at the point of the first ventilatory threshold (VT1) -- the exercise intensity above which ventilation begins to increase disproportionately to oxygen consumption. Higher values indicate greater aerobic exercise capacity and improved cardiovascular fitness. | 16 weeks (end of control period) and 32 weeks (end of intervention) |
| Peak Oxygen Consumption (VO2 Max) | Maximum rate of oxygen consumption (VO2 max) measured during incremental exercise on a cycle ergometer, expressed in milliliters per kilogram per minute (ml/kg/min). Reflects overall cardiorespiratory fitness and aerobic capacity. Higher values indicate better cardiovascular fitness; values < 17.5 ml/kg/min in dialysis patients are associated with increased cardiovascular risk. | 16 weeks (end of control period) and 32 weeks (end of intervention) |
| 27428340 | Background | Mendez-Duran A, Ignorosa-Luna MH, Perez-Aguilar G, Rivera-Rodriguez FJ, Gonzalez-Izquierdo JJ, Davila-Torres J. [Current status of alternative therapies renal function at the Instituto Mexicano del Seguro Social]. Rev Med Inst Mex Seguro Soc. 2016 Sep-Oct;54(5):588-93. Spanish. |
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| 8517388 | Background | Gupta S, Dev V, Kumar MV, Dash SC. Left ventricular diastolic function in end-stage renal disease and the impact of hemodialysis. Am J Cardiol. 1993 Jun 15;71(16):1427-30. doi: 10.1016/0002-9149(93)90604-b. |
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| 28395286 | Background | Antlanger M, Aschauer S, Kopecky C, Hecking M, Kovarik JJ, Werzowa J, Mascherbauer J, Genser B, Saemann MD, Bonderman D. Heart Failure with Preserved and Reduced Ejection Fraction in Hemodialysis Patients: Prevalence, Disease Prediction and Prognosis. Kidney Blood Press Res. 2017;42(1):165-176. doi: 10.1159/000473868. Epub 2017 Apr 11. |
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| 27037982 | Background | Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available. |
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| COMPLETED |
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| NOT COMPLETED |
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| 2. Intradialytic exercise - 16 weeks |
|
Participants who completed the first phase of the study were taken into account.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prevalent Patients in Hemodiafiltration | Prevalent patients having hemodiafiltration sessions 3 times a week, they used to do intradialytic exercise but this exercise was neither measured, quantified, or supervised, so they were withdrawn from this exercise for 16 weeks and after this time, 16 weeks of structured, measured and supervised intradialytic exercise was introduced. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of the participant at the time of enrollment, expressed in years | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Medication | Use of medication for specific therapies at the beginning of the study | Count of Participants | Participants |
| |||||||||||||||||
| Dry-Weight Body Mass Index | A measure of body fat based on height and dry weight | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||
| Dialysis vintage | Total time in weeks since the initiation of chronic hemodialysis treatment | Median | Inter-Quartile Range | weeks |
| ||||||||||||||||
| Comorbidities | Prevalence of pre-existing clinical conditions at study enrollment | Count of Participants | Participants |
| |||||||||||||||||
| Etiology | The primary underlying cause of renal failure. | Count of Participants | Participants |
| |||||||||||||||||
| Laboratory values | Baseline values of hemoglobin and albumin | Median | Inter-Quartile Range | g/dl |
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| Left Ventricular Diastolic Function Category | Classification of left ventricular diastolic function into ordinal grades based on the 2016 ASE/EACVI guidelines. Classification is determined by integrating E/A ratio, average E/e' ratio, indexed left atrial volume (LAVi), and tricuspid regurgitation (TR) velocity. Grades are defined as follows: Grade 1 (mild, impaired relaxation) is the least severe; Grade 2 (moderate, pseudonormal filling) represents intermediate severity; Grade 3 (severe, restrictive filling) is the most severe form of diastolic dysfunction. | Count of Participants | Participants |
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| Left Atrial Reservoir Strain (LASr) | Peak longitudinal deformation of the left atrium during the reservoir phase measured by 2D speckle tracking echocardiography. Expressed as a percentage (%). Higher values indicate better left atrial reservoir function and, indirectly, less elevation in left ventricular filling pressures. | Mean | Standard Deviation | Percentage |
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| Left Ventricular Global Longitudinal Strain (GLS) | Assessment of myocardial deformation using 2D speckle tracking echocardiography. Values are expressed as a negative percentage (%); more negative values indicate better longitudinal contraction (e.g., -17.4% is better than -15.5%) | Mean | Standard Deviation | Percentage |
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| Automated Left Ventricular Ejection Fraction (AutoLVEF) | Automated left ventricular ejection fraction (%), calculated using automated contour detection software applied to 2D echocardiographic images. Represents the proportion of blood ejected from the left ventricle with each heartbeat. Higher values indicate better left ventricular systolic function; values >= 52% are considered within normal range. | Mean | Standard Deviation | Percentage |
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| Tricuspid Annular Plane Systolic Excursion (TAPSE) | Tricuspid annular plane systolic excursion (TAPSE), measured in millimeters (mm) by M-mode echocardiography at the lateral tricuspid annulus. Reflects right ventricular longitudinal systolic function. Higher values indicate better right ventricular function; values >= 17 mm are considered within normal range. | Mean | Standard Deviation | Millimeters (mm) |
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| Distance Covered in the Six-Minute Walk Test (6MWT) | Total distance in meters (m) that a patient can quickly walk on a flat, hard surface in a period of 6 minutes based on the guidelines of the American and European Thoracic Societies by two medical interns, who are trained to perform the test. It assesses functional capacity and response to the exercise intervention. Greater distances indicate better functional exercise capacity. | Median | Inter-Quartile Range | Meters (m) |
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| Physical Activity Level (GPPAQ) | General Practice Physical Activity Questionnaire. Self-administered questionnaire for adults consisting of 3 questions assessing type and amount of physical activity at work, during leisure time, and usual walking pace. Classifies patients into 4 levels: Inactive, Moderately Inactive, Moderately Active, and Active. Higher activity levels represent better physical activity status; Active is the most favorable and Inactive is the least favorable category. | Of the 21 enrolled participants, questionnaire data were available and analyzable for 13 participants. Data from 8 participants were excluded due to incomplete or non-interpretable responses, limiting valid scoring of the instrument. | Count of Participants | Participants |
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| Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' ratio) | Non-invasive estimate of left ventricular filling pressure calculated as the ratio of early diastolic mitral inflow velocity (E wave, pulsed-wave Doppler) to the average of septal and lateral mitral annular early diastolic velocities (e', tissue Doppler imaging). Higher values indicate elevated filling pressures. | Mean | Standard Deviation | ratio |
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| Mitral Inflow E/A Ratio | Ratio of early diastolic (E wave) to late diastolic (A wave) mitral inflow velocities measured by pulsed-wave Doppler echocardiography with the sample volume placed at the mitral valve leaflet tips, apical four-chamber view. Reflects left ventricular relaxation and filling patterns. | Mean | Standard Deviation | ratio |
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| Left Atrial Volume Index (LAVi) | Left atrial volume indexed to body surface area (ml/m^2) measured by the biplane Simpson method using apical four-chamber and two-chamber views. Reflects left atrial structural remodeling as a marker of chronic elevation in left ventricular filling pressures. Lower values indicate less atrial remodeling and are associated with better diastolic function; values <= 34 ml/m2 are within the normal range per ASE 2016 guidelines. | Mean | Standard Deviation | ml/m^2 |
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| Tricuspid regurgitation velocity | Peak tricuspid regurgitation velocity (cm/s) assessed by continuous-wave Doppler echocardiography, used to estimate right ventricular systolic pressure and pulmonary artery pressure per the 2016 ASE/EACVI diastolic function guidelines. Lower values are associated with lower estimated pulmonary pressures and less severe diastolic dysfunction; values <= 2.8 m/s are within the normal range. | Mean | Standard Deviation | cm/s |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Left Ventricular Global Longitudinal Strain (GLS) | Assessment of myocardial deformation using 2D speckle tracking echocardiography. Values are expressed as a negative percentage (%); more negative values indicate better longitudinal contraction (e.g., -17.4% is better than -15.5%) | Posted | Mean | Standard Deviation | Percentage | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Secondary | Automated Left Ventricular Ejection Fraction (AutoLVEF) | Automated left ventricular ejection fraction (%), calculated using automated contour detection software applied to 2D echocardiographic images. Represents the proportion of blood ejected from the left ventricle with each heartbeat. Higher values indicate better left ventricular systolic function; values >= 52% are considered within normal range. | Posted | Mean | Standard Deviation | Percentage | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Primary | Left Ventricular Diastolic Function Category | Classification of left ventricular diastolic function into ordinal grades based on the 2016 ASE/EACVI guidelines. Classification is determined by integrating E/A ratio, average E/e' ratio, indexed left atrial volume (LAVi), and tricuspid regurgitation (TR) velocity. Grade 1 (mild, impaired relaxation) is the least severe; Grade 2 (moderate, pseudonormal filling) represents intermediate severity; Grade 3 (severe, restrictive filling) is the most severe. Grading criteria: Grade 1 (mild - impaired relaxation): E/A < 0.8, average E/e' ≤ 14, LAVi ≤ 34 ml/m², TR velocity ≤ 2.8 m/s; fewer than 2 positive criteria. Grade 2 (moderate - pseudonormal filling): E/A 0.8-2.0, with ≥ 2 of the following positive: average E/e' > 14, LAVi > 34 ml/m², TR velocity > 2.8 m/s. Grade 3 (severe - restrictive filling): E/A > 2.0, or E/A 0.8-2.0 with all three criteria positive. | Posted | Count of Participants | Participants | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Primary | Left Atrial Reservoir Strain (LASr) | Peak longitudinal deformation of the left atrium during the reservoir phase measured by 2D speckle tracking echocardiography. Expressed as a percentage (%). Higher values indicate better left atrial reservoir function and, indirectly, less elevation in left ventricular filling pressures. | Posted | Mean | Standard Deviation | Percentage | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Secondary | Tricuspid Annular Plane Systolic Excursion (TAPSE) | Tricuspid annular plane systolic excursion (TAPSE), measured in millimeters (mm) by M-mode echocardiography at the lateral tricuspid annulus. Reflects right ventricular longitudinal systolic function. Higher values indicate better right ventricular function; values >= 17 mm are considered within normal range. | Posted | Mean | Standard Deviation | millimeters (mm) | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Secondary | Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' Ratio) | Non-invasive estimate of left ventricular filling pressure calculated as the ratio of early diastolic mitral inflow velocity (E wave, pulsed-wave Doppler) to the average of septal and lateral mitral annular early diastolic velocities (e', tissue Doppler imaging). Higher values indicate elevated filling pressures. | Posted | Mean | Standard Deviation | ratio | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
|
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| Secondary | Mitral Inflow E/A Ratio | Ratio of early diastolic (E wave) to late diastolic (A wave) mitral inflow velocities measured by pulsed-wave Doppler echocardiography with the sample volume placed at the mitral valve leaflet tips, apical four-chamber view. Reflects left ventricular relaxation and filling patterns. | Posted | Mean | Standard Deviation | ratio | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
|
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| Secondary | Left Atrial Volume Index (LAVi) | Left atrial volume indexed to body surface area (ml/m^2) measured by the biplane Simpson method using apical four-chamber and two-chamber views. Reflects left atrial structural remodeling as a marker of chronic elevation in left ventricular filling pressures. Lower values indicate less atrial remodeling and are associated with better diastolic function; values <= 34 ml/m2 are within the normal range per ASE 2016 guidelines. | Posted | Mean | Standard Deviation | ml/m^2 | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
|
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| Secondary | Tricuspid Regurgitation Velocity | Peak tricuspid regurgitation velocity (cm/s) assessed by continuous-wave Doppler echocardiography, used to estimate right ventricular systolic pressure and pulmonary artery pressure per the 2016 ASE/EACVI diastolic function guidelines. Lower values are associated with lower estimated pulmonary pressures and less severe diastolic dysfunction; values <= 2.8 m/s are within the normal range. | Posted | Mean | Standard Deviation | cm/s | 16 weeks (end of control period) and 32 weeks (end of intervention period) |
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| Post-Hoc | Left Atrial Reservoir Strain (LASr) - Three-Timepoint Sensitivity Analysis | Left atrial reservoir strain assessed by 2D speckle tracking echocardiography at three study timepoints as a pre-specified sensitivity analysis. Expressed as percentage (%). | Posted | Mean | Standard Deviation | Percent | Baseline, 16 weeks (end of control period), and 32 weeks (end of intervention) |
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| Post-Hoc | Automated Left Ventricular Ejection Fraction (AutoLVEF) - Three-Timepoint Sensitivity Analysis | Automated left ventricular ejection fraction assessed by echocardiography using automated contour detection software at three study timepoints as a pre-specified sensitivity analysis. Expressed as percentage (%). | Posted | Mean | Standard Deviation | Percent (%) | Baseline, 16 weeks (end of control period), and 32 weeks (end of intervention) |
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| Post-Hoc | Mitral Inflow E/A Ratio - Three-Timepoint Sensitivity Analysis | Ratio of early diastolic (E) to late diastolic (A) mitral inflow velocities measured by pulsed-wave Doppler echocardiography at three study timepoints as a pre-specified sensitivity analysis. | Posted | Mean | Standard Deviation | ratio | Baseline, 16 weeks (end of control period), and 32 weeks (end of intervention) |
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| Post-Hoc | Left Atrial Volume Index (LAVi) - Three-Timepoint Sensitivity Analysis | Left atrial volume indexed to body surface area (ml/m^2) measured by biplane Simpson echocardiography at three study timepoints as a pre-specified sensitivity analysis. | Posted | Mean | Standard Deviation | ml/m^2 | Baseline, 16 weeks (end of control period), and 32 weeks (end of intervention) |
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| Post-Hoc | Tricuspid Regurgitation Velocity - Three-Timepoint Sensitivity Analysis | Peak tricuspid regurgitation velocity (cm/s) assessed by continuous-wave Doppler echocardiography at three study timepoints as a pre-specified sensitivity analysis | Posted | Mean | Standard Deviation | cm/s | Baseline, 16 weeks (end of control period), and 32 weeks (end of intervention) |
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| Secondary | Physical Activity Level (GPPAQ) | General Practice Physical Activity Questionnaire. Self-administered questionnaire for adults consisting of 3 questions assessing type and amount of physical activity at work, during leisure time, and usual walking pace. Classifies patients into 4 levels: Inactive, Moderately Inactive, Moderately Active, and Active. Higher activity levels represent better physical activity status; Active is the most favorable and Inactive is the least favorable category. | Of the 21 enrolled participants, questionnaire data were available and analyzable for 13 participants. Data from 8 participants were excluded due to incomplete or non-interpretable responses, limiting valid scoring of the instrument. | Posted | Count of Participants | Participants | 16 weeks (end of control period), and 32 weeks (end of intervention) |
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| Secondary | Distance Covered in the Six-Minute Walk Test (6MWT) | Total distance in meters (m) that a patient can quickly walk on a flat, hard surface in a period of 6 minutes based on the guidelines of the American and European Thoracic Societies by two medical interns, who are trained to perform the test. It assesses functional capacity and response to the exercise intervention. Greater distances indicate better functional exercise capacity. | Posted | Median | Inter-Quartile Range | Meters (m) | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Secondary | Peak Workload (Maximal Power Output) | Peak workload (maximal power output) is defined as the highest power output (in watts) achieved during a symptom-limited incremental CPET on a cycle ergometer, corresponding to the last fully completed workload stage or the highest workload maintained for ≥30 seconds. Higher values indicate greater maximal aerobic exercise capacity. | Posted | Mean | Standard Deviation | Watts | 16 weeks (end of control period), and 32 weeks (end of intervention) |
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| Secondary | Workload at First Ventilatory Threshold (VT1) | Power output (watts) achieved during a cardiopulmonary exercise test (CPET) at the point of the first ventilatory threshold (VT1) -- the exercise intensity above which ventilation begins to increase disproportionately to oxygen consumption. Higher values indicate greater aerobic exercise capacity and improved cardiovascular fitness. | Posted | Mean | Standard Deviation | Watts (W) | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Secondary | Peak Oxygen Consumption (VO2 Max) | Maximum rate of oxygen consumption (VO2 max) measured during incremental exercise on a cycle ergometer, expressed in milliliters per kilogram per minute (ml/kg/min). Reflects overall cardiorespiratory fitness and aerobic capacity. Higher values indicate better cardiovascular fitness; values < 17.5 ml/kg/min in dialysis patients are associated with increased cardiovascular risk. | Posted | Mean | Standard Deviation | ml/kg/min | 16 weeks (end of control period) and 32 weeks (end of intervention) |
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| Post-Hoc | Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' Ratio) - Three Timepoint Sensitivity Analysis | Ratio of early mitral inflow velocity to the average mitral annular velocity (E/e') assessed at three study timepoints as part of the pre-specified echocardiographic sensitivity analysis. Higher values indicate elevated left ventricular filling pressures. | Posted | Mean | Standard Deviation | ratio | Baseline (week 0), 16 weeks (end of control period), and 32 weeks (end of intervention period) |
|
During the 16-week intradialytic exercise intervention period (Period 2).
Adverse events were monitored exclusively during the Intradialytic Exercise Phase (Intervention Period, 16 weeks, 921 hemodialysis sessions) by trained medical staff during and immediately after each exercise session. No adverse event monitoring was conducted during the Control Phase (Period 1), as no exercise intervention was performed during that period and no exercise-related events were expected or recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients in Hemodiafiltration | Patients having hemodiafiltration sessions 3 times a week, they used to do intradialytic exercise but this exercise was neither measured, quantified, or supervised, so they were withdrawn from this exercise for 16 weeks and after this time, 16 weeks of structured, measured and supervised intradialytic exercise was introduced. | 0 | 21 | 0 | 21 | 19 | 21 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intradialytic Hypotension | Cardiac disorders | Systematic Assessment | Decrease in systolic blood pressure ≥ 20 mmHg or mean arterial pressure ≥ 10 mmHg associated with clinical symptoms requiring nursing intervention. Managed according to standard unit protocols without long-term complications or study withdrawal. |
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| Headache | Nervous system disorders | Systematic Assessment | Reports of cephalalgia occurring during or following the exercise component of the hemodialysis session |
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| Dizziness | Nervous system disorders | Systematic Assessment | A sensation of unsteadiness, lightheadedness, or spinning during or shortly after the exercise intervention. Most cases were transient and associated with initial physical fatigue during the first weeks of the program |
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| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment | Episodes of involuntary and painful skeletal muscle contractions, primarily affecting the lower extremities, occurring during or immediately following the intradialytic pedaling session. |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | A subjective sensation of abdominal discomfort with an urge to vomit, occurring during the physical exertion phase of the dialysis session. Classified as a mild event, typically self-limiting or resolved by reducing the intensity of the exercise |
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Study limitations include a small sample size (n=21), which may limit power to detect changes in categorical grading. The quasi-experimental, before-and-after design lacked a parallel control group; however, the self-controlled design minimized inter-individual variability in the uremic milieu. To mitigate the operator-dependent nature of echocardiography, automated strain software was used, and reading cardiologists were blinded to the study phase.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MSc, MD Salvador Lopez Gil | Instituto Nacional de Cardiologia Ignacio Chavez | +52 5555732911 | salvadorlgil@gmail.com |
| Mar 20, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059565 | G2 Phase Cell Cycle Checkpoints |
| C092779 | RE1-silencing transcription factor |
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D059447 | Cell Cycle Checkpoints |
| D002453 | Cell Cycle |
| D002468 | Cell Physiological Phenomena |
| D016195 | G2 Phase |
| D007399 | Interphase |
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
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| Unknown or Not Reported |
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| Vitamin D analogues |
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| Phosphate binders |
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| Erythropoietin |
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| Type 2 diabetes |
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