Cardiorespiratory Prevention and Rehabilitation Program (PROCOR): Assessment and Prescription of Exercises for People With Cardiometabolic Diseases.

April 7, 2026 updated by: Aline Mendes Gerage, Universidade Federal de Santa Catarina

Cardiorespiratory Prevention and Rehabilitation Program (PROCOR)

The global aging of the population presents significant challenges to health and quality of life, especially among the elderly, who face a higher prevalence of cardiometabolic risk factors. Additionally, aging is associated with increases in blood pressure (BP) and a gradual loss of functional capacity. On the other hand, physical exercise improves various cardiometabolic and functional aspects of the elderly. However, determining the ideal weekly frequency of physical training for this population is uncertain, requiring further investigation of the manipulation of this training variable on overall health parameters. Therefore, the aim of this study was to compare the effect of two different weekly frequencies of combined training on the functional capacity, hemodynamic, and anthropometric aspects of elderly individuals with cardiometabolic risk factors. The study adopted an uncontrolled clinical trial design, focused on investigating the effects of combined training over 12 weeks, conducted at the Federal University of Santa Catarina (UFSC) and involved elderly participants from the Cardiopulmonary Prevention and Rehabilitation Program (PROCOR). Participants underwent a wide range of assessments, including anthropometric measurements, functional capacity tests through the Senior Fitness Test battery and the 1000-meter test, as well as blood pressure assessments using automatic equipment. Then, participants were divided into two groups: G2x, which trained twice a week, and G3x, which trained three times a week during the intervention period, which consisted of three mesocycles of four weeks each with intensity progression. Data analysis was performed by intention-to-treat (ITT) and per-protocol (PP), using generalized estimating equations, with Bonferroni post-hoc adjustment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88035-972
        • Sports Center - Federal University of Santa Catarina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of hypertension, diabetes mellitus, and/or another cardiovascular disease;
  • Provide medical documentation confirming the diagnosis (e.g., medical report or prescription);
  • Present a medical clearance for participation in physical exercise issued by a cardiologist or endocrinologist;
  • If diagnosed with cardiovascular disease, provide a recent exercise stress test at the beginning of the study.

Exclusion Criteria:

  • Not properly using medication for an existing chronic condition;
  • Presenting severe complications of the existing chronic condition (e.g., severe autonomic neuropathy in individuals with Diabetes);
  • Having muscular and/or joint impairments that prevent the performance of physical exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Group 2 times per week
The group training twice per week (G2x) performed sessions on Tuesdays and Thursdays. The training consisted in aerobic exercise combined with strength training. Further details are specified in the intervention description.
Behavioral: PROCOR 2024.1
Aerobic training consisted of interval and pyramidal treadmill exercises, with participants autonomously adjusting speed and incline according to their perceived exertion. Those in G2x alternated equally between speed- and incline-focused sessions. Strength training included bench press, leg press, seated row, and abductor machine exercises. At the start of each mesocycle, a load assessment test was conducted using two sets with the same load; adjustments were made based on second-set performance to maintain the prescribed repetition range. Participants were familiarized with the Borg 6-20 scale, treadmill speed and incline adjustments, and resistance exercises, receiving instruction on proper technique and selection of an appropriate initial load.
Experimental: Exercise Group 3 times per week
The group trained three times a week (G3x) had sessions on Tuesdays, Thursdays, and Fridays. For those who trained three times a week, two sessions with speed variation and one with incline were assigned. The training consisted in aerobic exercise combined with strength training. Further details are specified in the intervention description.
Behavioral: PROCOR 2024.1
Aerobic training consisted of interval and pyramidal treadmill exercises, with participants autonomously adjusting speed and incline according to their perceived exertion. Those in G2x alternated equally between speed- and incline-focused sessions. Strength training included bench press, leg press, seated row, and abductor machine exercises. At the start of each mesocycle, a load assessment test was conducted using two sets with the same load; adjustments were made based on second-set performance to maintain the prescribed repetition range. Participants were familiarized with the Borg 6-20 scale, treadmill speed and incline adjustments, and resistance exercises, receiving instruction on proper technique and selection of an appropriate initial load.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in strength
Time Frame: Baseline and 12 weeks
Lower limb strength was measured using the 30-second sit-to-stand test. The test result used was the number of repetitions performed in this time, in one attempt. Upper limb strength was assessed using the 30-second arm curl test, with a 2.0 kg dumbbell for women and a 4.0 kg dumbbell for men. The test result was the total number of curls completed in a single attempt with the dominant arm.
Baseline and 12 weeks
change in balance/Agility
Time Frame: Baseline and 12 weeks
Agility/dynamic balance was measured using the Timed Up and Go (TUG) test. The test result was the shortest time to stand up from a seated position, walk 3.00 meters, turn around, and return to the seated position. The TUG was performed at two walking speeds (maximum and usual), with two attempts for each, and the shortest time of each speed was recorded.
Baseline and 12 weeks
change in flexibility
Time Frame: Baseline and 12 weeks
Flexibility was assessed using the sit-and-reach test, in which participants sat on a mat with their legs fully extended and their feet placed against a box used for the test, reaching forward. The total distance reached represented the final score, with two reach attempts recorded.
Baseline and 12 weeks
change in cardiorespiratory fitness
Time Frame: Baseline and 12 weeks
Aerobic capacity was evaluated using two tests: the 6-minute walk test (6MWT), which participants completed one attempt, and the result was the total distance covered in that time; and the 1000-meter test (1000m), that was developed due to the presence of a ceiling effect observed in the 6MWT in many participants in previous PROCOR training semesters, in which participants also made one attempt, and the score was the total time in seconds to complete the distance, allowing walking and/or running.
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in clinic systolic blood pressure
Time Frame: Baseline and 12 weeks
Three blood pressure measurements were obtained using a portable automatic monitor (OMRON, model HEM-7200, Brazil). Each participant remained seated and in silence for 10 minutes, and then three measurements of blood pressure and heart rate were taken, with a one-minute interval between each. The same procedure was repeated on a second day, resulting in a total of six systolic and diastolic blood pressure (DBP) measurements (in mmHg) and six heart rate measurements. The final values were determined by calculating the arithmetic mean of the measurements from both days, resulting in the final average.
Baseline and 12 weeks
Change in clinic diastolic blood pressure
Time Frame: Baseline and 12 weeks
Three blood pressure measurements were obtained using a portable automatic monitor (OMRON, model HEM-7200, Brazil). Each participant remained seated and in silence for 10 minutes, and then three measurements of blood pressure and heart rate were taken, with a one-minute interval between each. The same procedure was repeated on a second day, resulting in a total of six systolic and diastolic blood pressure (DBP) measurements (in mmHg) and six heart rate measurements. The final values were determined by calculating the arithmetic mean of the measurements from both days, resulting in the final average.
Baseline and 12 weeks
Change in clinic mean blood pressure
Time Frame: Baseline and 12 weeks
Three blood pressure measurements were obtained using a portable automatic monitor (OMRON, model HEM-7200, Brazil). Each participant remained seated and in silence for 10 minutes, and then three measurements of blood pressure and heart rate were taken, with a one-minute interval between each. The same procedure was repeated on a second day, resulting in a total of six systolic and diastolic blood pressure (DBP) measurements (in mmHg) and six heart rate measurements. The final values were determined by calculating the arithmetic mean of the measurements from both days, resulting in the final average. Additionally, mean arterial pressure (MAP) was calculated using the standard equation: MAP = (Systolic Blood Pressure + 2 × Diastolic Blood Pressure) / 3(2).
Baseline and 12 weeks
change in fasting glucose
Time Frame: Baseline and 12 weeks
The fasting glucose will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Baseline and 12 weeks
change in total cholesterol
Time Frame: Baseline and 12 weeks
The total cholesterol will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Baseline and 12 weeks
change in HDL-cholesterol
Time Frame: Baseline and 12 weeks
The HDL-cholesterol will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. The concentration of LDL-cholesterol is calculated using the Friedewald formula. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Baseline and 12 weeks
change in triglycerides
Time Frame: Baseline and 12 weeks
The lipid profile triglycerides will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Santa Catarina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aline Mendes Gerage, PhD, Federal University of Santa Catarina (UFSC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROCOR 2024.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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