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

NCT04476576 | Active Not Recruiting DMC

• 1 other identifier: exercise and chemotherapy
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cardiotoxicity; Systolic Dysfunction; Exercise, Aerobic

Keywords

cardiotoxicity; systolic dysfunction; exercise, aerobic; chemotherapy; strain

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (13)

• Left ventricular ejection fraction (LVEF)

  1 year

• GLS

  1 year

• Cardiotoxicity incidense

  1 year

• Diastolic function. E/e´index

  1 year

• Diastolic function. Left atrial GLS

  1 year

Study Arms (2)

Aerobic

EXPERIMENTAL

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

Behavioral: Aerobic exercise (experimental)

Flexibility

ACTIVE COMPARATOR

3 months program, 3 times/week flexibility ambulatory program

Behavioral: Flexibility exercise (active comparator)

Interventions

Aerobic exercise (experimental) 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.

Aerobic

Flexibility exercise (active comparator) 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.

Flexibility

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lucía Florio: lead

Study Sites (1)

Centro Cardiovascular Universitario-Hospital de Clínicas -FMED- UdelaR

Montevideo, 11600, Uruguay

Location

MeSH Terms

Conditions

Cardiotoxicity; Motor Activity; Sprains and Strains

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lucia Florio, MD MSc

  Universidad de la Republica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both programs are equally planned related with time and number of sessions as well as clinical monitoring.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Cardiology

Model Details: Active group: 3 months , 3 times/week aerobic program Control group: 3 months, 3 times/week flexibility program

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 20, 2020
• Study Start: March 2, 2021
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1)