Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXE-HDF
Brief Summary:
Introduction Cardiovascular diseases are the leading cause of morbidity and mortality in hemodialysis patients primarily due to structural cardiac changes that lead to diastolic dysfunction Furthermore this population has a high prevalence of sedentary behavior and increased mortality associated with it Recent studies have implemented exercise regimens in the chronic kidney disease population demonstrating improvements in various parameters related to cardiovascular disease
Objectives To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function
Materials and Methods This is a quasi-experimental study before-and-after type that will be conducted in two phases In the first phase rest both incident and prevalent hemodialysis patients will receive treatment for 3 months A baseline echocardiogram will be performed and then repeated at the end of the first phase to determine left ventricular diastolic function parameters The second phase of the study intradialytic exercise will take place during the following 3 months with an echocardiogram performed at the beginning and end of this phase Systematic prescribed and supervised intradialytic aerobic exercise intradialytic pedaling will be implemented Additionally a 6-minute walk test and a validated physical activity questionnaire will be administered monthly during both phases of the study
Objectives To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function
Materials and Methods This is a quasi-experimental study before-and-after type that will be conducted in two phases In the first phase rest both incident and prevalent hemodialysis patients will receive treatment for 3 months A baseline echocardiogram will be performed and then repeated at the end of the first phase to determine left ventricular diastolic function parameters The second phase of the study intradialytic exercise will take place during the following 3 months with an echocardiogram performed at the beginning and end of this phase Systematic prescribed and supervised intradialytic aerobic exercise intradialytic pedaling will be implemented Additionally a 6-minute walk test and a validated physical activity questionnaire will be administered monthly during 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 2004 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 in the unit andor those who join the hemodialysis program at the National Institute of Cardiology prevalent and incident hemodialysis patients
Eligible Population
Patients with chronic kidney disease both prevalent and incident 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 3-month hemodialysis period without exercise All echocardiograms will be performed before the first dialysis session of the week Monday or Tuesday according to the patients session schedule At the end of the 3 months a final transthoracic echocardiogram will be performed The second phase of the study which consists of hemodialysis with intradialytic exercise for 3 months 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 patients 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 Skinners 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
2 times a week during the hemodialysis session incident patients
3 times a week during the hemodialysis session prevalent 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-HRrest40-80 HRrest and Borgs 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 35 MHz transducer The following measurements will be taken
Early transmitral flow velocity E wave
Late diastolic transmitral flow velocity A wave
EA 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 Ee 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 1-29 hoursweek of physical exercise or cycling or standing work and 1 hourweek of physical exercise or cycling or physically active work without physical exercise or cycling and active sedentary work and 3 hoursweek of physical exercise or cycling or standing work and 1-29 hoursweek of physical exercise or cycling or physically active work and 1 hour of physical exercise or cycling or work with vigorous PA
The implementation of intradialytic exercise in the hemodialysis unit of our Institute began in 2004 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 in the unit andor those who join the hemodialysis program at the National Institute of Cardiology prevalent and incident hemodialysis patients
Eligible Population
Patients with chronic kidney disease both prevalent and incident 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 3-month hemodialysis period without exercise All echocardiograms will be performed before the first dialysis session of the week Monday or Tuesday according to the patients session schedule At the end of the 3 months a final transthoracic echocardiogram will be performed The second phase of the study which consists of hemodialysis with intradialytic exercise for 3 months 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 patients 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 Skinners 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
2 times a week during the hemodialysis session incident patients
3 times a week during the hemodialysis session prevalent 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-HRrest40-80 HRrest and Borgs 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 35 MHz transducer The following measurements will be taken
Early transmitral flow velocity E wave
Late diastolic transmitral flow velocity A wave
EA 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 Ee 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 1-29 hoursweek of physical exercise or cycling or standing work and 1 hourweek of physical exercise or cycling or physically active work without physical exercise or cycling and active sedentary work and 3 hoursweek of physical exercise or cycling or standing work and 1-29 hoursweek of physical exercise or cycling or physically active work and 1 hour of physical exercise or cycling or work with vigorous PA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None