Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05487716
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2022-07-21
Brief Title:
HIIT Effects on Long-term Survival in Heart Failure Patients
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Effects of High-Intensity Interval Training on Long-term Survival in Patients With Different Heart Failure Phenotypes
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The American Heart Association announces that exercise training should be considered for all stable cardiac patients Class I Level A Therefore exercise is an important issue for cardiac patients It has also been reported that high-intensity interval training HIIT brings benefits on reversal of cardiac remodeling and long-term survival for HF patients This study explores high-intensity interval training HIIT effects on long-term survivals in heart failure HF patients diagnosed according to the Framingham criteria
This retrospective cohort study is going to analyze HF patients diagnosed between January 1 2009 and May 31 2022 in a tertiary care hospital All HF patients underwent the multidisciplinary disease management program MDP in the hospital were initially surveyed Participants were further categorized into HF with reduced ejection fraction HFrEF left ventricle ejection fraction LVEF40 HF with mildly reduced EF HFmrEF LVEF40 and LVEF 50 and HF with preserved EF HFpEF LVEF50 based on the initial 2-D echocardiography Participants will be further divided into HIITMDP or MDP only in each group based on patient preference
Age sex body height body weight disease duration etiology for HF co-morbidities and medication were documented during follow-up FU B-type natriuretic peptide natriuretic peptide BNP cardiopulmonary exercise test CPET for peak oxygen consumption VO2peak and 2-D echocardiography for LV geometry were repeatedly assessed during follow-up The end-point is the death of the patients or the date of May 31 2022 All mortality causes and overall survival rates will be determined at the end of FU
HIIT effects on long-term survival Kaplan-Meier survival curve for patients with different heart failure phenotypes will be estimated by log rank test Continuous variables between different groups were analyzed by student t-test while continuous variables before and after HIIT within groups were assessed by paired t-test Other non-continuous variables such as sex and co-morbidities were compared by chi-square test
This retrospective cohort study is going to analyze HF patients diagnosed between January 1 2009 and May 31 2022 in a tertiary care hospital All HF patients underwent the multidisciplinary disease management program MDP in the hospital were initially surveyed Participants were further categorized into HF with reduced ejection fraction HFrEF left ventricle ejection fraction LVEF40 HF with mildly reduced EF HFmrEF LVEF40 and LVEF 50 and HF with preserved EF HFpEF LVEF50 based on the initial 2-D echocardiography Participants will be further divided into HIITMDP or MDP only in each group based on patient preference
Age sex body height body weight disease duration etiology for HF co-morbidities and medication were documented during follow-up FU B-type natriuretic peptide natriuretic peptide BNP cardiopulmonary exercise test CPET for peak oxygen consumption VO2peak and 2-D echocardiography for LV geometry were repeatedly assessed during follow-up The end-point is the death of the patients or the date of May 31 2022 All mortality causes and overall survival rates will be determined at the end of FU
HIIT effects on long-term survival Kaplan-Meier survival curve for patients with different heart failure phenotypes will be estimated by log rank test Continuous variables between different groups were analyzed by student t-test while continuous variables before and after HIIT within groups were assessed by paired t-test Other non-continuous variables such as sex and co-morbidities were compared by chi-square test
Detailed Description:
METHODS Participants The institutional review board of a tertiary care hospital approved the retrospective cohort study protocol Patients with cardiovascular events between 1 January 2009 and 31 May 2022 in a tertiary care hospital and the following criteria were included
Patients with a diagnosis of HF according to the Framingham HF diagnostic criteria
HF patients with stable clinical presentation for 4 weeks
All included subjects received individualized patient education under optimized guideline-based management ie multi-disciplinary disease management program MDP by the HF care team Investigators excluded individuals based on the following criteria
Age 20 years and 80 years
Pregnancy
Chance of cardiac transplantation within 6 months
Moderate to severe chronic obstructive pulmonary disease
Uncompensated HF
Estimated glomerular filtration rate 30 mlmin173m2
Absolute contraindications for exercise suggested by the American College of Sports Medicine
Unable to perform exercise caused by non-cardiac disease
Clinical Assessment Investigators recorded baseline age sex body mass index co-morbidities serum b-type natriuretic peptide levels incremental cardiopulmonary exercise test CPET findings and 2-D echocardiography measurements in all included participants The physical component score PCS and mental component score MCS of the Medical Outcomes Study 36-item Short Form were used to evaluate quality of life QoL before initiating CPET
Exercise Training Eligible HF patients who underwent an additional 36 sessions 2-3 sessions per week of supervised bicycle ergometer Ergoselect 150P ergoline GmbH Germany training for 3-4 months were classified as the HIIT participant Participants exercised alternatively at 3-min interval of 80 VO2peak and 3-min interval of 40 VO2peak for 30 min each session The remaining participants without supervised HIIT were classified as the MDP participant
Cardiopulmonary Exercise Test All participants underwent incremental CPET within 1 week before HIIT Minute ventilation VE as well as CO2 ventilation VCO2 and oxygen consumption VO2 were measured breath by breath VO2peak VE-VCO2 slope systemic arteriovenous O2 difference Da-vO2 and peak cardiac output during the exercise test COex were defined
Echocardiography 2-D echocardiography images were acquired at end-expiration with a 2-5 MHz tightly curved-array ultrasound transducer Vivid 7 General Electric Healthcare Chicago IL USA or Phillips IE33 Philips Healthcare Andover MA USA to measure LV end-diastolic dimension LVEDD LV end-systolic diameter LVESD and LVEF for all participants HF patients with LVEF40 LVEF 40 and 50 and LVEF50 were considered to have HFrEF HFmrEF and HFpEF respectively
Follow-Up All participants were followed up until 31 May 2022 or when death occurred during the observational period All HIIT participants underwent secondary CPET QoL assessment and 2-D echocardiography within 1 week after completing 36 sessions of HIIT After completing the exercise training HIIT participants received the same treatment program as the MDP participants until the end of FU 2-D echocardiography was performed during the long-term FU at an interval of 3 to 12 months for all participants Dates and causes of death were also documented
Statistical Analysis Baseline demographic information between the HIIT and MDP participants with different HF phenotypes will be compared by Students t test for continuous variables and chi-squared test for categorical variables For HIIT participants ANOVA will be used to estimate differences in cardiorespiratory fitness and cardiac geometry after exercise training among the three phenotypes Differences of the above evaluations between two among the three phenotypes will be estimated by the Bonferroni post hoc test Paired t test will be used to assess HIIT effects on cardiorespiratory fitness and cardiac geometry in each phenotype
To avoid immortal time bias the index date for HIIT participants will be the date of exercise completion while the index date for MDP participants will be the date of CPET examination Kaplan-Meier survival curves for HF patients based on their exercise status for all HF patients and the different HF phenotypes will be assessed by log-rank test The multivariable Cox regression will be used to investigate clinical predictors for mortality after conducting data exploration to select variables in the multivariable Cox model
Heatmaps will be used to present the effect of HIIT on changes in LVEF and LV dimensions for different phenotypes during the long-term FU The HIIT-induced changes of LV geometry in each phenotype will be compared by Students t test P 005 was considered statistically significant
Patients with a diagnosis of HF according to the Framingham HF diagnostic criteria
HF patients with stable clinical presentation for 4 weeks
All included subjects received individualized patient education under optimized guideline-based management ie multi-disciplinary disease management program MDP by the HF care team Investigators excluded individuals based on the following criteria
Age 20 years and 80 years
Pregnancy
Chance of cardiac transplantation within 6 months
Moderate to severe chronic obstructive pulmonary disease
Uncompensated HF
Estimated glomerular filtration rate 30 mlmin173m2
Absolute contraindications for exercise suggested by the American College of Sports Medicine
Unable to perform exercise caused by non-cardiac disease
Clinical Assessment Investigators recorded baseline age sex body mass index co-morbidities serum b-type natriuretic peptide levels incremental cardiopulmonary exercise test CPET findings and 2-D echocardiography measurements in all included participants The physical component score PCS and mental component score MCS of the Medical Outcomes Study 36-item Short Form were used to evaluate quality of life QoL before initiating CPET
Exercise Training Eligible HF patients who underwent an additional 36 sessions 2-3 sessions per week of supervised bicycle ergometer Ergoselect 150P ergoline GmbH Germany training for 3-4 months were classified as the HIIT participant Participants exercised alternatively at 3-min interval of 80 VO2peak and 3-min interval of 40 VO2peak for 30 min each session The remaining participants without supervised HIIT were classified as the MDP participant
Cardiopulmonary Exercise Test All participants underwent incremental CPET within 1 week before HIIT Minute ventilation VE as well as CO2 ventilation VCO2 and oxygen consumption VO2 were measured breath by breath VO2peak VE-VCO2 slope systemic arteriovenous O2 difference Da-vO2 and peak cardiac output during the exercise test COex were defined
Echocardiography 2-D echocardiography images were acquired at end-expiration with a 2-5 MHz tightly curved-array ultrasound transducer Vivid 7 General Electric Healthcare Chicago IL USA or Phillips IE33 Philips Healthcare Andover MA USA to measure LV end-diastolic dimension LVEDD LV end-systolic diameter LVESD and LVEF for all participants HF patients with LVEF40 LVEF 40 and 50 and LVEF50 were considered to have HFrEF HFmrEF and HFpEF respectively
Follow-Up All participants were followed up until 31 May 2022 or when death occurred during the observational period All HIIT participants underwent secondary CPET QoL assessment and 2-D echocardiography within 1 week after completing 36 sessions of HIIT After completing the exercise training HIIT participants received the same treatment program as the MDP participants until the end of FU 2-D echocardiography was performed during the long-term FU at an interval of 3 to 12 months for all participants Dates and causes of death were also documented
Statistical Analysis Baseline demographic information between the HIIT and MDP participants with different HF phenotypes will be compared by Students t test for continuous variables and chi-squared test for categorical variables For HIIT participants ANOVA will be used to estimate differences in cardiorespiratory fitness and cardiac geometry after exercise training among the three phenotypes Differences of the above evaluations between two among the three phenotypes will be estimated by the Bonferroni post hoc test Paired t test will be used to assess HIIT effects on cardiorespiratory fitness and cardiac geometry in each phenotype
To avoid immortal time bias the index date for HIIT participants will be the date of exercise completion while the index date for MDP participants will be the date of CPET examination Kaplan-Meier survival curves for HF patients based on their exercise status for all HF patients and the different HF phenotypes will be assessed by log-rank test The multivariable Cox regression will be used to investigate clinical predictors for mortality after conducting data exploration to select variables in the multivariable Cox model
Heatmaps will be used to present the effect of HIIT on changes in LVEF and LV dimensions for different phenotypes during the long-term FU The HIIT-induced changes of LV geometry in each phenotype will be compared by Students t test P 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None