NCT07019506

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2025Aug 2026

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

June 5, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

cardiovascula diseasesexerciseaerobic capacity

Outcome Measures

Primary Outcomes (1)

  • 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

    2015-2024

Secondary Outcomes (1)

  • Cardiovascular risk

    2015-2024

Interventions

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

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Records containing incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación universitaria María Cano

Medellín, Colombia

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Catalina Lopera, Msc in cancer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator MSc Clinical leadership in cancer and palliative care

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 13, 2025

Study Start

January 1, 2025

Primary Completion

September 30, 2025

Study Completion (Estimated)

August 30, 2026

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF
Time Frame
Data requests can be submitted starting 12 months after article publication and the data will made accessible for up to 18 months. Extensions will be considered on a case-by-case basis
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact catalinaloperamuneton@fumc.edu.co

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