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Aerobic Exercise is Cardio-protective in Hemato-oncological Disease and New-onset Chemotherapy

NCT ID: NCT04476576

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-02

Study Completion Date

2025-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Cardiotoxicity Systolic Dysfunction Exercise, Aerobic

Keywords

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cardiotoxicity systolic dysfunction exercise, aerobic chemotherapy strain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active group: 3 months , 3 times/week aerobic program Control group: 3 months, 3 times/week flexibility program
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Both programs are equally planned related with time and number of sessions as well as clinical monitoring.

Study Groups

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Aerobic

3 months program, 3 times/week aerobic ambulatory program.

Group Type EXPERIMENTAL

Aerobic exercise (experimental)

Intervention Type BEHAVIORAL

3 times per week, 30 minutes each time. Entrance in heat: 8-10 min of joint mobility and / or the aerobic exercise in the main part at light intensity (OMNI 3-4) Main part: minimum 30 minutes, maximun 60 minutes. Intensity: moderate, guided by Talk Test and effort perception scale 5-6 OMNI. Type: aerobic, cycling or walking at home using a treadmill or exercise bike and / or cycling and walking outdoors according to the patient's possibilities and preferences. Return to calm: 5 min of aerobic physical activity of main part at mild intensity (OMNI 3-4), then static stretching. Pictures with each type of exercise will be offered and detailed explained.

Flexibility

3 months program, 3 times/week flexibility ambulatory program

Group Type ACTIVE_COMPARATOR

Flexibility exercise (active comparator)

Intervention Type BEHAVIORAL

Entrance in heat: 10 min of joint mobility. Main part: Minimum 30 minutes. Frequency: 3 times por week Intensity: The patient should be able to slowly stretch the muscle to a position of mild discomfort. Type: Static Stretch Time: 15-30 seconds 2 repetitions of each stretch Number of exercises: 12 . Pictures with each muscle group to exercise will be offered and detailed explained.

Interventions

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Aerobic exercise (experimental)

3 times per week, 30 minutes each time. Entrance in heat: 8-10 min of joint mobility and / or the aerobic exercise in the main part at light intensity (OMNI 3-4) Main part: minimum 30 minutes, maximun 60 minutes. Intensity: moderate, guided by Talk Test and effort perception scale 5-6 OMNI. Type: aerobic, cycling or walking at home using a treadmill or exercise bike and / or cycling and walking outdoors according to the patient's possibilities and preferences. Return to calm: 5 min of aerobic physical activity of main part at mild intensity (OMNI 3-4), then static stretching. Pictures with each type of exercise will be offered and detailed explained.

Intervention Type BEHAVIORAL

Flexibility exercise (active comparator)

Entrance in heat: 10 min of joint mobility. Main part: Minimum 30 minutes. Frequency: 3 times por week Intensity: The patient should be able to slowly stretch the muscle to a position of mild discomfort. Type: Static Stretch Time: 15-30 seconds 2 repetitions of each stretch Number of exercises: 12 . Pictures with each muscle group to exercise will be offered and detailed explained.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 75 years old
* New-onset chemotherapy
* Lymphoma (Hodgkin or non-Hodgkin).

Exclusion Criteria

* Inability or contraindication to moderate physical activity due to orthopedic cause or general disease (excluding oncological).
* Hemato-oncological pathology different from lymphomas.
* Lymphomas not treated with anthracyclines
* Non-sinus rhythm.
* Poor echocardiographic window (inability to assess longitudinal strain in more than 4 segments).
* Physically active subjects (practice aerobic exercise at least 30 minutes, 3 times / week, 3 previous months).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lucía Florio

OTHER

Sponsor Role lead

Responsible Party

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Lucía Florio

Associate Professor Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lucia Florio, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad de la Republica

Locations

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Centro Cardiovascular Universitario-Hospital de Clínicas -FMED- UdelaR

Montevideo, , Uruguay

Site Status

Countries

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Uruguay

Other Identifiers

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exercise and chemotherapy

Identifier Type: -

Identifier Source: org_study_id