CardiotoxicityAEROHEMONCONCT04476576
Aerobic Exercise is Cardio-protective in Hemato-oncological Disease and New-onset Chemotherapy
A study testing Aerobic exercise (experimental) and Flexibility exercise (active comparator) in people with Cardiotoxicity and Systolic Dysfunction, run by Lucía Florio at 1 site in Uruguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiotoxicity, Systolic Dysfunction, Exercise, Aerobic
- What is being tested?
- Aerobic exercise (experimental) and Flexibility exercise (active comparator)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUruguay
- Study dates
- 2 Mar 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 75 years old
- New-onset chemotherapy
- Lymphoma (Hodgkin or non-Hodgkin).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Uruguay1 site
Centro Cardiovascular Universitario-Hospital de Clínicas -FMED- UdelaR
Montevideo, 11600
About this study
Official title: Aerobic Physical Exercise is Cardio-protective in Subjects With Hemato-oncological Disease and New-onset Chemotherapy
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).
Read the detailed 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.
- Conditions
- Cardiotoxicity, Systolic Dysfunction, Exercise, Aerobic
- Being tested
- Aerobic exercise (experimental), Flexibility exercise (active comparator)
- Keywords
- cardiotoxicity, systolic dysfunction, exercise, aerobic, chemotherapy, strain
- Medical subject headings
- Cardiotoxicity, Motor Activity, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise (experimental)Behavioural
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 exercise (active comparator)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic | Experimental | 3 months program, 3 times/week aerobic ambulatory program. Receives: Behavioral: Aerobic exercise (experimental) |
| Flexibility | Active comparator | 3 months program, 3 times/week flexibility ambulatory program Receives: Behavioral: Flexibility exercise (active comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GLS (exercise of flexibility and balance).
GLS will be measured as the mean value of all segments pick systolic longitudinal strain expressed in percentage (%). The method will be speckle tracking, with a 4 MHz traducer and ViviIQ General Electric echocardiographer, The difference between GLS pre Chemotherapy minus post-chemotherapy and GLS pre chemotherapy minus a year after.
Measured: 6 months
Secondary outcomes (13)
Left ventricular ejection fraction (LVEF)
LVEF evaluated through Simpson biplane method, expressed in percentage. The value to compare will be those at the end of chemotherapy and a year after the beginning.
Measured: 1 year
GLS
GLS evaluated through speckle tracking method, expressed in percentage. The value to compare will be those at the end of chemotherapy and a year after the beginning.
Measured: 1 year
Cardiotoxicity incidense
Cardiotoxicity definition: Decline of 10% or more of LVEF (pre chemotherapy value is the reference). Incidence of cardiotoxicity will be compared at the end of chemotherapy and one year after.
Measured: 1 year
Diastolic function. E/e´index
Pick value of E wave (pulse Doppler at the tip of mitral valve, first positive wave) and pick value of e´(mean of basal septal and basal lateral e´ , evaluated with tissue Doppler). The comparison will be done at the end of chemotherapy and 1 year from the beginning.
Measured: 1 year
Diastolic function. Left atrial GLS
Biplane atrial GLS expressed in percentage (%). Method for estimation: speckle tracking. The comparison will be at the end of chemotherapy and 1 year from the beginning.
Measured: 1 year
Diastolic function. Left atrial volume.
Biplane left atrial volume, through longitud-area method, expressed in ml. The comparison will be at the end of chemotherapy and 1 year from the beginning.
Measured: 1 year
Cardiac injury. Troponin I dosification.
Dosification of troponin I value (ng/ml) between groups (data from Day 8 to 11 of third chem cycle)
Measured: 3 months
Clinical cardiovascular composite outcome
Incidence of HF incomes and cardiovascular mortality during the follow-up year between groups. Comparison of survival free of events (Kaplan Meier curve and long rank test).
Measured: 1 year
Muscle corporal mass
Percentage of muscle mass calculated through a bioimpedance balance. Comparison will be made baseline, at 3 months and a year.
Measured: 1 year
Physical activity. Monthly mean of steps.
The monthly average of daily physical activity during the 3 months duration of the exercise program measured by steps of a physical activity wristband.
Measured: 3 months
Quality of life. Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ)
Minnesota questionnaire for HF patients: It is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses. The response format ranges from 0 (none or not applicable), to 1(very little) to 5 (very much). The simple sum of the responses that ranges from 0 to 105 is a measurement of heart failure severity as indicated by its adverse effect on the respondent's life during the past month. The MLHFQ scores increase with the adverse impact of heart failure on the respondent's life. Evaluation made at the end of exercise program.
Measured: 3 months
Quality of life. Functional Assessment of Cancer Therapy (FACT)
FACT-G (general) questionnaire for oncological patients.General quality of life instrument intended for use with a variety of chronic illness conditions. Originally validated in a general cancer population.Administration: Self Time to complete: 5 minutes. Number of items:27 Domains \& categories: 4 Name of categories/domains: Physical, social/family, emotional, and functional well-being. Scaling of items: Five-point scale from 0 (not at all) to 4 (very much). Evaluation made at the end of exercise program.
Measured: 3 months
Dysnea
PROMIS questionnarie for dysnea severity evaluation.The PROMIS Dyspnea Severity item bank assesses the severity of shortness of breath or difficulty breathing an adult experiences in response to various specific activities. Each activity is rated in terms of degree of dyspnea (no shortness of breath, mildly short of breath, moderately short of breath, severely short of breath) while engaging in the activity over the past 7 days, with higher scores reflecting greater levels of dyspnea. Respondents who indicate that they did not perform an activity in the past 7 days will not produce a score for that item. The bank includes 33 items.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start2 Mar 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active group: 3 months , 3 times/week aerobic program Control group: 3 months, 3 times/week flexibility program
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucía Florio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucía Florio, Universidad de la Republica
- Investigators
- Lucia Florio, MD MSc, Principal investigator, Universidad de la Republica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476576
- Sponsor's protocol ID
- exercise and chemotherapy
- Acronym
- AEROHEMONCO
- Status last verified
- Dec 2024
- First submitted
- 7 Jul 2020
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Physical Exercise is Cardio-protective in Subjects With Hemato-oncological Disease and New-onset Chemotherapy
- ClinicalTrials.gov ID
- NCT04476576
- Acronym / sponsor ID
- AEROHEMONCO / exercise and chemotherapy
- Conditions
- Cardiotoxicity, Systolic Dysfunction, Exercise, Aerobic
- Keywords
- cardiotoxicity, systolic dysfunction, exercise, aerobic, chemotherapy, strain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Lucía FlorioUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Active group: 3 months , 3 times/week aerobic program Control group: 3 months, 3 times/week flexibility program
| Arm | Type | Receives |
|---|---|---|
| Aerobic | Experimental | Behavioral: Aerobic exercise (experimental)3 months program, 3 times/week aerobic ambulatory program. |
| Flexibility | Active comparator | Behavioral: Flexibility exercise (active comparator)3 months program, 3 times/week flexibility ambulatory program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18 and 75 years old
- New-onset chemotherapy
- Lymphoma (Hodgkin or non-Hodgkin).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Aerobic |
| 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. | Behavioural | Flexibility |
Primary outcome
Change in GLS (exercise of flexibility and balance).
Time frame: 6 months
GLS will be measured as the mean value of all segments pick systolic longitudinal strain expressed in percentage (%). The method will be speckle tracking, with a 4 MHz traducer and ViviIQ General Electric echocardiographer, The difference between GLS pre Chemotherapy minus post-chemotherapy and GLS pre chemotherapy minus a year after.
13 secondary outcomes
Left ventricular ejection fraction (LVEF)
Time frame: 1 year
GLS
Time frame: 1 year
Cardiotoxicity incidense
Time frame: 1 year
Diastolic function. E/e´index
Time frame: 1 year
Diastolic function. Left atrial GLS
Time frame: 1 year
Diastolic function. Left atrial volume.
Time frame: 1 year
Cardiac injury. Troponin I dosification.
Time frame: 3 months
Clinical cardiovascular composite outcome
Time frame: 1 year
Muscle corporal mass
Time frame: 1 year
Physical activity. Monthly mean of steps.
Time frame: 3 months
Quality of life. Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ)
Time frame: 3 months
Quality of life. Functional Assessment of Cancer Therapy (FACT)
Time frame: 3 months
Dysnea
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Florio, MD MSc principal investigator
Universidad de la Republica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise (experimental) and Flexibility exercise (active comparator) in people with Cardiotoxicity and Systolic Dysfunction, run by Lucía Florio at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GLS (exercise of flexibility and balance). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.