Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients (EXE-HDF)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Kidney Failure; Renal Dialysis; Diastolic Dysfunction; Hemodiafiltration; Aerobic Training
• Intervention / Treatment: Other: Not exercise; Other: Exercise during hemodiafiltration session

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14080
      • Instituto Nacional de Cardiologia Ignacio Chavez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: Not 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.; Other Names: Rest; Control Phase; Control Period; Pre-Exercise; Other: Exercise during hemodiafiltration session; 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).; Other Names: Intervention period; Intradialytic Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Collaborators: Instituto Mexicano de Investigaciones Nefrológicas

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aerobic training; Hemodiafiltration; Intradialytic Exercise; Diastolic Disfunction
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Surgical Procedures, Operative; Cell Physiological Phenomena; Patient Care; Health Services; Health Care Facilities Workforce and Services; Exercise; Perioperative Care; Cell Cycle Checkpoints; Cell Cycle; G2 Phase; Interphase; Preoperative Exercise; RE1-silencing transcription factor; G2 Phase Cell Cycle Checkpoints
• Other Study ID Numbers: PT-23-1378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No