Renal DialysisEXE-HDFNCT06584734
Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
A study testing Not exercise and Exercise during hemodiafiltration session in people with Renal Dialysis and Hemodiafiltration, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Hemodiafiltration, Diastolic Dysfunction
- What is being tested?
- Not exercise and Exercise during hemodiafiltration session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 17 Sep 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults ≥ 18 years
- Both genders
- Patients currently enrolled in the hemodialysis program at the National Institute of Cardiology unit
- Patients on hemodialysis for at least 3 months prior to enrollment
- Echocardiographic evidence of left ventricular diastolic dysfunction
- Patients with sufficient cognitive ability to understand and follow study instructions
Show all 9Show fewer
- Patients with a good echocardiographic window that allows for the determination of parameters evaluating left ventricular diastolic function
- Patients capable of performing stationary cycling during hemodialysis sessions
- Patients who agree to participate and provide written informed consent prior to enrollment
Who cannot join
- Patients who have had a major cardiovascular event (MI, stroke) in the 3 months prior to the start of the study
- Patients who have visited the emergency room for symptoms of decompensated heart failure in the 3 months prior to the start of the study
- Patients diagnosed with atrial fibrillation and/or atrial flutter
- Patients with a mechanical mitral valve prosthesis
- Patients with orthopedic conditions or physical limitations that preclude lower-limb stationary cycling
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Mexico City, 14080
About this study
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.
Read the detailed description
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:
- Non-randomized clinical trial (quasi-experimental, before-and-after study).
- Purpose: Analytical
- Temporal sequence: Longitudinal
- Control of study factor assignment: Experimental
- Chronology: Prospective
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:
- F: Frequency
- I: Intensity
- T: Time
- T: Type
- V: Volume or amount of exercise
- P: Progression
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:
- Early transmitral flow velocity (E wave)
- Late diastolic transmitral flow velocity (A wave)
- E/A ratio in an apical 4-chamber view with pulsed Doppler, placing the sample volume at the tips of the mitral valve leaflets.
- Tissue Doppler imaging (TDI) will be performed in an apical 4-chamber view to determine septal e' and lateral e' waves, with the pulsed Doppler sample volume placed 5 mm in the medial and lateral regions of the mitral annulus. The E/e' ratio will be calculated.
- Left atrial (LA) volume will be measured in an apical 4-chamber view and indexed to body surface area.
- Tricuspid regurgitation velocity (TR) will be measured with continuous Doppler in the apical 4-chamber approach focused on the right ventricle.
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.
- Conditions
- Renal Dialysis, Hemodiafiltration, Diastolic Dysfunction, Kidney Failure, Quality of Life, Aerobic Training
- Being tested
- Not exercise, Exercise during hemodiafiltration session
- Keywords
- Hemodiafiltration, Intradialytic Exercise, Diastolic Disfunction, Aerobic training
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not exerciseOther
Also called Control Phase, Rest, Control Period, Pre-Exercise
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.
Exercise during hemodiafiltration sessionOther
Also called Intervention period, Intradialytic Exercise
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Not exercise; Other: Exercise during hemodiafiltration session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 weeks (end of control period) and 32 weeks (end of intervention)
Secondary outcomes (12)
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%)
Measured: 16 weeks (end of control period) and 32 weeks (end of intervention)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks (end of control period) and 32 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start17 Sep 2023
- Primary completion30 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano de Investigaciones Nefrológicas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584734
- Sponsor's protocol ID
- PT-23-1378
- Acronym
- EXE-HDF
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2024
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27648403Vasquez-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.
PubMed 35368596Mendez-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.
PubMed 27428340Collins AJ, Foley RN, Herzog C, Chavers B, Gilbertson D, Ishani A, Kasiske B, Liu J, Mau LW, McBean M, Murray A, St Peter W, Guo H, Gustafson S, Li Q, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Dalleska F, Daniels F, Dunning S, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers P, Agodoa L. US Renal Data System 2010 Annual Data Report. Am J Kidney Dis. 2011 Jan;57(1 Suppl 1):A8, e1-526. doi: 10.1053/j.ajkd.2010.10.007. No abstract available.
PubMed 21184928Johansen KL, Chertow GM, Foley RN, Gilbertson DT, Herzog CA, Ishani A, Israni AK, Ku E, Kurella Tamura M, Li S, Li S, Liu J, Obrador GT, O'Hare AM, Peng Y, Powe NR, Roetker NS, St Peter WL, Abbott KC, Chan KE, Schulman IH, Snyder J, Solid C, Weinhandl ED, Winkelmayer WC, Wetmore JB. US Renal Data System 2020 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2021 Apr;77(4 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2021.01.002. No abstract available.
PubMed 33752804Di Lullo L, House A, Gorini A, Santoboni A, Russo D, Ronco C. Chronic kidney disease and cardiovascular complications. Heart Fail Rev. 2015 May;20(3):259-72. doi: 10.1007/s10741-014-9460-9.
PubMed 25344016Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
PubMed 15385656Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.
PubMed 15882252Gupta 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.
PubMed 8517388Ruffmann K, Mandelbaum A, Bommer J, Schmidli M, Ritz E. Doppler echocardiographic findings in dialysis patients. Nephrol Dial Transplant. 1990;5(6):426-31. doi: 10.1093/ndt/5.6.426.
PubMed 2122318Antlanger 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.
PubMed 28395286Sarafidis PA, Kamperidis V, Loutradis C, Tsilonis K, Mpoutsiouki F, Saratzis A, Giannakoulas G, Sianos G, Karvounis H. Haemodialysis acutely deteriorates left and right diastolic function and myocardial performance: an effect related to high ultrafiltration volumes? Nephrol Dial Transplant. 2017 Aug 1;32(8):1402-1409. doi: 10.1093/ndt/gfw345.
PubMed 27738230Drighil A, Madias JE, Mathewson JW, El Mosalami H, El Badaoui N, Ramdani B, Bennis A. Haemodialysis: effects of acute decrease in preload on tissue Doppler imaging indices of systolic and diastolic function of the left and right ventricles. Eur J Echocardiogr. 2008 Jul;9(4):530-5. doi: 10.1093/ejechocard/jen125. Epub 2008 Mar 27.
PubMed 18490307Nagueh 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.
PubMed 27037982Malik J, Kudlicka J, Valerianova A, Kovarova L, Kmentova T, Lachmanova J. Diastolic dysfunction in asymptomatic hemodialysis patients in the light of the current echocardiographic guidelines. Int J Cardiovasc Imaging. 2019 Feb;35(2):313-317. doi: 10.1007/s10554-019-01564-2. Epub 2019 Feb 27.
PubMed 30815807
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06584734
- Acronym / sponsor ID
- EXE-HDF / PT-23-1378
- Conditions
- Renal Dialysis, Hemodiafiltration, Diastolic Dysfunction, Kidney Failure, Quality of Life, Aerobic Training
- Keywords
- Hemodiafiltration, Intradialytic Exercise, Diastolic Disfunction, Aerobic training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- Instituto Mexicano de Investigaciones Nefrológicas
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Non-randomized clinical trial (quasi-experimental, before-and-after study).
- Purpose: Analytical
- Temporal sequence: Longitudinal
- Control of study factor assignment: Experimental
- Chronology: Prospective
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:
- F: Frequency
- I: Intensity
- T: Time
- T: Type
- V: Volume or amount of exercise
- P: Progression
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:
- Early transmitral flow velocity (E wave)
- Late diastolic transmitral flow velocity (A wave)
- E/A ratio in an apical 4-chamber view with pulsed Doppler, placing the sample volume at the tips of the mitral valve leaflets.
- Tissue Doppler imaging (TDI) will be performed in an apical 4-chamber view to determine septal e' and lateral e' waves, with the pulsed Doppler sample volume placed 5 mm in the medial and lateral regions of the mitral annulus. The E/e' ratio will be calculated.
- Left atrial (LA) volume will be measured in an apical 4-chamber view and indexed to body surface area.
- Tricuspid regurgitation velocity (TR) will be measured with continuous Doppler in the apical 4-chamber approach focused on the right ventricle.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevalent patients in hemodiafiltration | Other | Other: Not exercise, Other: Exercise during hemodiafiltration sessionPrevalent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ≥ 18 years
- Both genders
- Patients currently enrolled in the hemodialysis program at the National Institute of Cardiology unit
- Patients on hemodialysis for at least 3 months prior to enrollment
- Echocardiographic evidence of left ventricular diastolic dysfunction
Key exclusion criteria (6 listed)
- Patients who have had a major cardiovascular event (MI, stroke) in the 3 months prior to the start of the study
- Patients who have visited the emergency room for symptoms of decompensated heart failure in the 3 months prior to the start of the study
- Patients diagnosed with atrial fibrillation and/or atrial flutter
- Patients with a mechanical mitral valve prosthesis
- Patients with orthopedic conditions or physical limitations that preclude lower-limb stationary cycling
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 |
|---|---|---|
| Not exerciseAlso: Control Phase, Rest, Control Period, Pre-ExercisePatients 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. | Other | Prevalent patients in hemodiafiltration |
| Exercise during hemodiafiltration sessionAlso: Intervention period, Intradialytic ExerciseA 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). | Other | Prevalent patients in hemodiafiltration |
Primary outcome
Left Ventricular Diastolic Function Category
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
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.
Left Atrial Reservoir Strain (LASr)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
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.
12 secondary outcomes
Left Ventricular Global Longitudinal Strain (GLS)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
Automated Left Ventricular Ejection Fraction (AutoLVEF)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' Ratio)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention period)
Mitral Inflow E/A Ratio
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention period)
Left Atrial Volume Index (LAVi)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention period)
Tricuspid Regurgitation Velocity
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention period)
Physical Activity Level (GPPAQ)
Time frame: 16 weeks (end of control period), and 32 weeks (end of intervention)
Distance Covered in the Six-Minute Walk Test (6MWT)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
Peak Workload (Maximal Power Output)
Time frame: 16 weeks (end of control period), and 32 weeks (end of intervention)
Workload at First Ventilatory Threshold (VT1)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
Peak Oxygen Consumption (VO2 Max)
Time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27648403Cusumano 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.
- Background: PubMed 35368596Vasquez-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.
- Background: PubMed 27428340Mendez-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.
- Background: PubMed 21184928Collins AJ, Foley RN, Herzog C, Chavers B, Gilbertson D, Ishani A, Kasiske B, Liu J, Mau LW, McBean M, Murray A, St Peter W, Guo H, Gustafson S, Li Q, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Dalleska F, Daniels F, Dunning S, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers P, Agodoa L. US Renal Data System 2010 Annual Data Report. Am J Kidney Dis. 2011 Jan;57(1 Suppl 1):A8, e1-526. doi: 10.1053/j.ajkd.2010.10.007. No abstract available.
- Background: PubMed 33752804Johansen KL, Chertow GM, Foley RN, Gilbertson DT, Herzog CA, Ishani A, Israni AK, Ku E, Kurella Tamura M, Li S, Li S, Liu J, Obrador GT, O'Hare AM, Peng Y, Powe NR, Roetker NS, St Peter WL, Abbott KC, Chan KE, Schulman IH, Snyder J, Solid C, Weinhandl ED, Winkelmayer WC, Wetmore JB. US Renal Data System 2020 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2021 Apr;77(4 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2021.01.002. No abstract available.
- Background: PubMed 25344016Di Lullo L, House A, Gorini A, Santoboni A, Russo D, Ronco C. Chronic kidney disease and cardiovascular complications. Heart Fail Rev. 2015 May;20(3):259-72. doi: 10.1007/s10741-014-9460-9.
- Background: PubMed 15385656Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
- Background: PubMed 15882252Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.
- Background: PubMed 8517388Gupta 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.
- Background: PubMed 2122318Ruffmann K, Mandelbaum A, Bommer J, Schmidli M, Ritz E. Doppler echocardiographic findings in dialysis patients. Nephrol Dial Transplant. 1990;5(6):426-31. doi: 10.1093/ndt/5.6.426.
- Background: PubMed 28395286Antlanger 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.
- Background: PubMed 27738230Sarafidis PA, Kamperidis V, Loutradis C, Tsilonis K, Mpoutsiouki F, Saratzis A, Giannakoulas G, Sianos G, Karvounis H. Haemodialysis acutely deteriorates left and right diastolic function and myocardial performance: an effect related to high ultrafiltration volumes? Nephrol Dial Transplant. 2017 Aug 1;32(8):1402-1409. doi: 10.1093/ndt/gfw345.
- Individual participant dataSharing planned: No
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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 Not exercise and Exercise during hemodiafiltration session in people with Renal Dialysis and Hemodiafiltration, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 9 inclusion and 6 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 1 May 2026. 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Left Ventricular Diastolic Function Category (time frame: 16 weeks (end of control period) and 32 weeks (end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06584734, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.