Aerobic Exercise is Cardio-protective in Hemato-oncological Disease and New-onset Chemotherapy (AEROHEMONCO)
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- STATUS
- Recruiting
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- End date
- Mar 20, 2024
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- participants needed
- 38
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- sponsor
- Lucía Florio
Summary
Oncological diseases are the main cause of death in developed countries and also in Uruguay. Advances in therapeutics have made possible to aspire to cure and in other cases long-term remission with a significant increase in survival and the transformation of cancer into a chronic disease. Chemotherapy treatments have some side effects and cardiotoxicity is well known within them. Heart failure (HF) is a progressive pathology, with high mortality and high resource requirements of the health system with a prognosis that may be worse than some types of cancers. The treatment of established systolic dysfunction and symptomatic HF is mainly based on the indication of inhibitors of the angiotensin-converting enzyme and beta-blockers among other pharmaceutical and no pharmaceutical interventions. Aerobic physical exercise, as a therapeutic intervention, reverses the physiopathological changes that are presumed to lead to HF in sedentary people and it is known, it is feasible to execute an exercise program in cancer patients. However, effective treatments for the primary prevention of systolic dysfunction are not well known. Our hypothesis is that an aerobic physical exercise program for at least 3 months, in subjects with lymphoma and new-onset chemotherapy, is effective in preventing left ventricular systolic dysfunction, at the end of chemotherapy and at one year. For this, the investigators propose a randomized, controlled, clinical study which is blind both for the patient and the evaluating physician, comparing the difference of global longitudinal strain (an echocardiographic result of myocardial function) pre-chemotherapy minus end of chemotherapy and minus one year after, between the active group (aerobic program) and the control group (flexibility program).
Description
Hypothesis: an aerobic physical exercise program for at least 3 months, in subjects with hemato-oncological diseases that initiate chemotherapy, is effective in preventing systolic dysfunction of the left ventricle at the end of chemotherapy and one year.
It is a double-blind, randomized controlled trial. Blinded for the subject, evaluating echocardiographic, and treating hematologist.
Blocked randomization method stratified by sex: the randomization sequence will be software generated and centralized by an investigator independent from assistant physicians and echocardiographic evaluator.
To calculate N sample the investigators took a 15% variation of longitudinal left ventricular strain ( clinically significant criteria). The mean and standard deviation of the healthy Uruguayan population was taken from an own study (19.6 ± 1.7%); considering alpha error 0.05 and power 80%, a sample of 16 in each group is required to find significant results. An additional 20% was added for possible "drop outs" resulting in a sample size of 19 subjects/group (N total 38).
The intervention is a 3 months aerobic exercise program compared with a 3 months flexibility exercise program.
The main outcome is the myocardial longitudinal strain variation. Secondary outcomes are related to systolic and diastolic cardiac function, quality of life, cardiac and oncological outcomes, and evaluation of adherence.
Statistical analysis: Qualitative variables will be expressed in absolute and relative frequency. Continuous variables will be resumed as mean and standard deviation or median and interquartile interval regarding normal distribution. Parametric or non- parametric tests of the association will be used regarding test of normality of each continuous outcome and Chi-squared test for the association of qualitative variables. Survival analysis will be made with Kaplan Meier curves and long rank test.
The project is registered in Uruguayan interventional trial registration (Ministery of Public Health) with the number 812559.
Details
| Condition | Cardiotoxicity, Systolic Dysfunction, Exercise, Aerobic |
|---|---|
| Treatment | Aerobic exercise (experimental), Flexibility exercise (active comparator) |
| Clinical Study Identifier | NCT04476576 |
| Sponsor | Lucía Florio |
| Last Modified on | 4 October 2022 |
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