Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients

NCT06584734 | Completed Results

• 1 other identifier: PT-23-1378
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hemodiafiltration; Diastolic Dysfunction; Renal Dialysis; Kidney Failure; Quality of Life; Aerobic Training

Keywords

Hemodiafiltration; Intradialytic Exercise; Diastolic Disfunction; Aerobic training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Left Ventricular Global Longitudinal Strain (GLS)

  16 weeks (end of control period) and 32 weeks (end of intervention)

• Automated Left Ventricular Ejection Fraction (AutoLVEF)

  16 weeks (end of control period) and 32 weeks (end of intervention)

• Tricuspid Annular Plane Systolic Excursion (TAPSE)

  16 weeks (end of control period) and 32 weeks (end of intervention)

• Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' Ratio)

  16 weeks (end of control period) and 32 weeks (end of intervention period)

• Mitral Inflow E/A Ratio

  16 weeks (end of control period) and 32 weeks (end of intervention period)

Study Arms (1)

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.

Other: Not exercise; Other: Exercise during hemodiafiltration session

Interventions

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.

Also known as: Control Phase, Rest, Control Period, Pre-Exercise

Prevalent patients in hemodiafiltration

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).

Also known as: Intervention period, Intradialytic Exercise

Prevalent patients in hemodiafiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead
• Instituto Mexicano de Investigaciones Nefrológicas: collaborator

Study Sites (1)

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Mexico City, 14080, Mexico

Location

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MeSH Terms

Conditions

Renal Insufficiency

Interventions

G2 Phase Cell Cycle Checkpoints; RE1-silencing transcription factor; Preoperative Exercise

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell Cycle Checkpoints; Cell Cycle; Cell Physiological Phenomena; G2 Phase; Interphase; Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

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.

Results Point of Contact

• Title: MSc, MD Salvador Lopez Gil
• Organization: Instituto Nacional de Cardiologia Ignacio Chavez

salvadorlgil@gmail.com

+52 5555732911

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Echocardiographic image acquisition and analysis were performed by echocardiographers blinded to the study phase (baseline, control, and intervention).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 5, 2024
• Study Start: September 17, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)