Effects Of Physical Training On Cardiovascular Capacity In Patients Undergoing Chemotherapy For Cancer

NCT07640087 | Not Yet Recruiting DMC

• 2 other identifiers: 88362125200005087CAAE:88362125200005087
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Cancer treatment, especially chemotherapy and radiotherapy, can lead to cardiovascular dysfunctions, such as a decrease in left ventricular ejection fraction and electrical dysfunction of the heart, which may consequently compromise patients' quality of life. In this context, physical exercise is a beneficial and promising tool, as it can prevent and minimize the deleterious effects of oncological therapies and their complications. Objective: To evaluate the effect of physical exercise on the prevention of cardiovascular diseases (CVD) induced by cancer treatment, analyzing the impact of supervised exercise on cardiovascular function and quality of life. Materials and Methods: This is a clinical trial in which the sample will consist of 60 individuals undergoing cancer treatment, who will be stratified and randomized according to cancer stage classification into two groups: Intervention Group (IG) and Control Group (CG). The intervention will last 12 weeks, during which the IG will receive a prescription for physical exercises based on the FITT principle (frequency, intensity, time, and type), three times per week, while the CG will remain under usual care. Data will be presented using descriptive statistics, tests for two independent samples, and multivariate analysis, comparing the intervention effects between the two groups using R software version 4.3.3. Expected Results: Low incidence of CVD, improved heart rate variability, adherence to the exercise protocol, reduced risk for cardiovascular diseases, improvement in fatigue, functional capacity, and quality of life. Data will be collected at baseline, at the 6th week, and at the 12th week of intervention.

Conditions

Cardiac Abnormalities; Chemotherapeutic Toxicity

Keywords

QUALITY OF LIFE; PAIN; EXERCISE

Outcome Measures

Primary Outcomes (3)

• Cardiotoxicity

  The biomarkers used for cardiovascular assessment of cancer patients are: ultrasensitive troponin I or T (marker of myocardial injury).

  From registration to the end of treatment in 12 weeks

• Heart rate variability

  Heart rate variability (HRV) will be measured using a Vantage V3 Polar® heart rate monitor that measures the electrical activity of the heart.

  From registration to the end of treatment in 12 weeks

• Cardiovascular risk in cancer patients.

  Cardiovascular risk will be assessed using the Framingham Scale, which measures the risk of cardiovascular disease in individuals through blood pressure, lipid profile (LDL and HDL), smoking, and diabetes, based on this data, which will be collected from patients' medical records.

  From registration to the end of treatment in 12 weeks

Secondary Outcomes (6)

• Fatigue

  From registration to the end of treatment in 12 weeks

• pain assessment

  From registration to the end of treatment in 12 weeks

• Quality of life Global

  From registration to the end of treatment in 12 weeks

• Body Composition

  From registration to the end of treatment in 12 weeks

• functional capacity

  From registration to the end of treatment in 12 weeks

Study Arms (2)

Experimental group: will undergo routine monitoring and evaluation, without exercise intervention.

NO INTERVENTION

Patients who will not participate in physical exercise programs, but will be monitored under the same clinical and monitoring conditions.

physical training

EXPERIMENTAL

patients undergoing chemotherapy treatment who will perform physical exercise.

Other: physical training

Interventions

physical training OTHER

The concurrent physical training program will last 12 weeks and will consist of aerobic and resistance exercises.The physical exercises for aerobic training will consist of walking and/or cycling on a stationary bike, performed 3 times a week with progressive intensity.Strength training exercises for upper (UL) and lower (LL) limbs will be performed using dumbbells, ankle weights, resistance bands, and body weight for patients undergoing chemotherapy.

Also known as: exercicio fisico, physical training, competing group

physical training

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a confirmed diagnosis of cancer who are undergoing chemotherapy treatment with anthracyclines;
• No physical exercise intervention for the past 3 months;
• Patients in the early or intermediate stages of cancer treatment;
• Adult patients (e.g., 18 to 59 years old) to avoid extreme variations in response to physical exercise;
• Clinically stable patients, without absolute contraindications to physical exercise (e.g., decompensated heart failure, severe arrhythmias);
• Patients able to participate in a supervised physical exercise program during the study period

You may not qualify if:

• Patients with severe pre-existing cardiac conditions (e.g., advanced cardiomyopathy, unstable angina) that prevent safe exercise practice;
• Patients with physical (e.g., inability to walk) or cognitive limitations that prevent participation in the physical exercise program;
• Patients undergoing treatments that may interfere with the results (e.g., recent thoracic radiotherapy, use of cardiotoxic agents unrelated to the study);
• Patients who already engage in regular and intense physical exercise, as this could interfere with the effects of the intervention.

Sponsors & Collaborators

• Federal University of Maranhao: lead

MeSH Terms

Conditions

Pain; Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

ANDREA DIAS REIS A Teacher, PhD

CONTACT

+5598987220570; andrea.dr@ufma.br

Abia Sousa studanty, Master's student

CONTACT

+5598984666714; abiiasf@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share