Cardiovascular DiseasesNCT07019506
Evaluation of the Effectiveness of Physical Exercise on Aerobic Capacity in Patients With Cardiovascular Disease
An observational study of Cardiovascular Diseases and Exercise, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.
Trial summary
According to the Pan American Health Organization (PAHO), non-communicable chronic diseases-primarily cardiovascular diseases-are the leading cause of death and disability worldwide. These conditions result in long-term health consequences and require significant ongoing treatment and care. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Cardiovascular Diseases, Exercise, Aerobic Capacity
- What is being tested?
- Cardiac rehabilitation
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2025to 30 Aug 2026
- Phase
- Observational
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women, between 35 and 90 years old, residents in the metropolitan area, with a diagnosis of cardiovascular disease who entered cardiovascualr patient care program from Clínica El Rosario.
Who may be able to join
- Records between 2015 and 2024
- Men and women, between 35 and 90 years old.
- Clinical diagnosis of cardiovascular disease.
- Must be patient from Clínica el Rosario.
- Participants must have completed a baseline exercise stress test and a post-intervention stress test after the 20 sessions, and must have attended at least 90% of the prescribed sessions
Who cannot join
- Records containing incomplete data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Fundación universitaria María Cano
Medellín
Catalina Lopera, Msc and Asocciate professor, +573206728934, catalinaloperamuneton@fumc.edu.co
About this study
According to the Pan American Health Organization (PAHO), non-communicable chronic diseases-primarily cardiovascular diseases-are the leading cause of death and disability worldwide. These conditions result in long-term health consequences and require significant ongoing treatment and care. Among them, ischemic heart diseases-most notably acute myocardial infarction-are highly prevalent. Globally, cardiovascular diseases are closely linked to physical inactivity as a major modifiable risk factor. In this context, exercise and physical activity have become public health priorities, with international guidelines recommending at least 150 minutes of moderate-intensity activity per week.
In Colombia, physical exercise is recognized as a key strategy for the prevention and management of non-communicable chronic diseases, as outlined in the national ten-year public health plan. However, evidence shows that few clinical services at the national or regional level consistently monitor or follow up on the proper prescription of exercise as a therapeutic strategy for cardiovascular disease management.
This study aims to describe the effectiveness of structured physical exercise on the aerobic capacity of patients with cardiovascular disease.
Read the detailed description
By 2030, the United Nations Sustainable Development Goals aim to reduce premature mortality from non-communicable diseases (NCDs) by one-third. Among these, cardiovascular diseases (CVDs)-including coronary heart disease and stroke-are the most common NCDs globally.
In recent years, myocardial infarction (MI) has emerged as one of the most potentially fatal coronary events, alongside coronary artery disease (CAD). According to the World Health Organization (WHO), an estimated 17.9 million people died in 2019 from CVDs, accounting for 32% of all global deaths. Of these, approximately 85% were due to MI and stroke. In Europe, CVDs are responsible for around 4 million deaths annually, representing about 47% of total mortality, with most cases associated with coronary disease. In the United States, the American Heart Association has estimated that approximately 15 million individuals over the age of 20 live with ischemic heart disease, affecting 6.4% of the population.
In the context of cardiac rehabilitation and secondary prevention, exercise training (ET) should be a core component of rehabilitation programs for cardiac patients. Its practice has been shown to improve exercise tolerance, quality of life, functional capacity, and performance in work-related physical tasks, while also reducing cardiovascular risk factors and cardiac mortality. Several studies have demonstrated that regular physical activity significantly enhances aerobic capacity in this population, leading to reduced cardiovascular risk and improved quality of life.
In terms of metabolic equivalents (METs), improved aerobic capacity is reflected by an increased oxygen uptake during physical activity, which enables patients to perform daily tasks with less effort and reduces strain on the cardiovascular system. Moreover, adherence to exercise programs has been identified as a key factor in achieving sustainable cardiovascular health benefits. However, adherence remains a challenge, particularly among patients with chronic diseases.
For this reason, there is a need for specific exercise programs that promote the modification of risk factors, support early intervention in cardiovascular patients, and enhance adherence to therapeutic interventions. These approaches could positively impact morbidity and mortality in this population and provide critical evidence for designing more effective cardiovascular rehabilitation strategies.
Within this context, the present study aims to evaluate the effectiveness of a structured exercise program in improving the aerobic capacity of patients diagnosed with cardiovascular disease.
The benefits of therapeutic exercise (TE) on cardiac remodeling appear to occur in both early and late phases. The early remodeling phase is characterized by expansion of the infarcted area, driven by the degradation of structural collagen in the extracellular matrix (ECM) by matrix metalloproteinases (MMPs), which are secreted by immune cells in response to MI-induced inflammation.
- Conditions
- Cardiovascular Diseases, Exercise, Aerobic Capacity
- Being tested
- Cardiac rehabilitation
- Keywords
- cardiovascula diseases, exercise, aerobic capacity
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
Sessions are conducted individually in accordance with cardiac rehabilitation guidelines, with a frequency of 2-3 times per week, each lasting 1 hour. Intensity is progressively increased on a weekly basis, with adaptations made according to each patient's specific needs. A total of 20 sessions are delivered, focused on improving the patient's cardiovascular capacity
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
The data will be collected from the clinical registries which have included. Aerobic capacity will be assessed through an exercise stress test, measured in metabolic equivalents (METs). Subsequently, VO₂max will be estimated using the NASA-derived formula. A poor physical fitness level will be defined as an estimated maximal oxygen consumption (VO₂max) of less than 7 METs
Measured: 2015-2024
Secondary outcomes (1)
Cardiovascular risk
The data will be collected from the clinical registries which have included Cardiovascular risk will be assessed using the American Heart Association (AHA) classification, which categorizes patients into low, moderate, high, and very high risk
Measured: 2015-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Universitaria Maria Cano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catalina Lopera Muñetón, Fundacion Universitaria Maria Cano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019506
- Sponsor's protocol ID
- 013008002-2024-311
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in cardiovascular diseases. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Physical Exercise on Aerobic Capacity in Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT07019506
- Acronym / sponsor ID
- 013008002-2024-311
- Conditions
- Cardiovascular Diseases, Exercise, Aerobic Capacity
- Keywords
- cardiovascula diseases, exercise, aerobic capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundacion Universitaria Maria CanoUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 13 Jun 2025 (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.
According to the Pan American Health Organization (PAHO), non-communicable chronic diseases-primarily cardiovascular diseases-are the leading cause of death and disability worldwide. These conditions result in long-term health consequences and require significant ongoing treatment and care. Among them, ischemic heart diseases-most notably acute myocardial infarction-are highly prevalent. Globally, cardiovascular diseases are closely linked to physical inactivity as a major modifiable risk factor. In this context, exercise and physical activity have become public health priorities, with international guidelines recommending at least 150 minutes of moderate-intensity activity per week.
In Colombia, physical exercise is recognized as a key strategy for the prevention and management of non-communicable chronic diseases, as outlined in the national ten-year public health plan. However, evidence shows that few clinical services at the national or regional level consistently monitor or follow up on the proper prescription of exercise as a therapeutic strategy for cardiovascular disease management.
This study aims to describe the effectiveness of structured physical exercise on the aerobic capacity of patients with cardiovascular disease.
Detailed description
By 2030, the United Nations Sustainable Development Goals aim to reduce premature mortality from non-communicable diseases (NCDs) by one-third. Among these, cardiovascular diseases (CVDs)-including coronary heart disease and stroke-are the most common NCDs globally.
In recent years, myocardial infarction (MI) has emerged as one of the most potentially fatal coronary events, alongside coronary artery disease (CAD). According to the World Health Organization (WHO), an estimated 17.9 million people died in 2019 from CVDs, accounting for 32% of all global deaths. Of these, approximately 85% were due to MI and stroke. In Europe, CVDs are responsible for around 4 million deaths annually, representing about 47% of total mortality, with most cases associated with coronary disease. In the United States, the American Heart Association has estimated that approximately 15 million individuals over the age of 20 live with ischemic heart disease, affecting 6.4% of the population.
In the context of cardiac rehabilitation and secondary prevention, exercise training (ET) should be a core component of rehabilitation programs for cardiac patients. Its practice has been shown to improve exercise tolerance, quality of life, functional capacity, and performance in work-related physical tasks, while also reducing cardiovascular risk factors and cardiac mortality. Several studies have demonstrated that regular physical activity significantly enhances aerobic capacity in this population, leading to reduced cardiovascular risk and improved quality of life.
In terms of metabolic equivalents (METs), improved aerobic capacity is reflected by an increased oxygen uptake during physical activity, which enables patients to perform daily tasks with less effort and reduces strain on the cardiovascular system. Moreover, adherence to exercise programs has been identified as a key factor in achieving sustainable cardiovascular health benefits. However, adherence remains a challenge, particularly among patients with chronic diseases.
For this reason, there is a need for specific exercise programs that promote the modification of risk factors, support early intervention in cardiovascular patients, and enhance adherence to therapeutic interventions. These approaches could positively impact morbidity and mortality in this population and provide critical evidence for designing more effective cardiovascular rehabilitation strategies.
Within this context, the present study aims to evaluate the effectiveness of a structured exercise program in improving the aerobic capacity of patients diagnosed with cardiovascular disease.
The benefits of therapeutic exercise (TE) on cardiac remodeling appear to occur in both early and late phases. The early remodeling phase is characterized by expansion of the infarcted area, driven by the degradation of structural collagen in the extracellular matrix (ECM) by matrix metalloproteinases (MMPs), which are secreted by immune cells in response to MI-induced inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women, between 35 and 90 years old, residents in the metropolitan area, with a diagnosis of cardiovascular disease who entered cardiovascualr patient care program from Clínica El Rosario.
Key inclusion criteria (5 listed)
- Records between 2015 and 2024
- Men and women, between 35 and 90 years old.
- Clinical diagnosis of cardiovascular disease.
- Must be patient from Clínica el Rosario.
- Participants must have completed a baseline exercise stress test and a post-intervention stress test after the 20 sessions, and must have attended at least 90% of the prescribed sessions
Key exclusion criteria (1 listed)
- Records containing incomplete data
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 |
|---|---|---|
| Cardiac rehabilitationSessions are conducted individually in accordance with cardiac rehabilitation guidelines, with a frequency of 2-3 times per week, each lasting 1 hour. Intensity is progressively increased on a weekly basis, with adaptations made according to each patient's specific needs. A total of 20 sessions are delivered, focused on improving the patient's cardiovascular capacity | Other | – |
Primary outcome
Aerobic capacity
Time frame: 2015-2024
The data will be collected from the clinical registries which have included. Aerobic capacity will be assessed through an exercise stress test, measured in metabolic equivalents (METs). Subsequently, VO₂max will be estimated using the NASA-derived formula. A poor physical fitness level will be defined as an estimated maximal oxygen consumption (VO₂max) of less than 7 METs
1 secondary outcome
Cardiovascular risk
Time frame: 2015-2024
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 11 Jul 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in cardiovascular diseases. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Exercise, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Jul 2025. 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 Colombia. 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?
Contact Catalina Lopera, Msc in cancer (+573206728934, catalinalopera8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (time frame: 2015-2024). 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 11 Jul 2025.