Risk Factors Cardiovascular DiseaseNCT07529158
Cardiorespiratory Prevention and Rehabilitation Program (PROCOR): Assessment and Prescription of Exercises for People With Cardiometabolic Diseases.
A study testing PROCOR 2024.1 in people with Risk Factors Cardiovascular Disease, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Risk Factors Cardiovascular Disease
- What is being tested?
- PROCOR 2024.1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sports Center - Federal University of Santa Catarina
Florianópolis, Santa Catarina, 88035-972
About this study
Official title: 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.
- Conditions
- Risk Factors Cardiovascular Disease
- Being tested
- PROCOR 2024.1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCOR 2024.1Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group 2 times per week | Experimental | 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. Receives: Behavioral: PROCOR 2024.1 |
| Exercise Group 3 times per week | Experimental | 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. Receives: Behavioral: PROCOR 2024.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in strength
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.
Measured: Baseline and 12 weeks
change in balance/Agility
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.
Measured: Baseline and 12 weeks
change in flexibility
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.
Measured: Baseline and 12 weeks
change in cardiorespiratory fitness
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.
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change in clinic systolic blood pressure
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.
Measured: Baseline and 12 weeks
Change in clinic diastolic blood pressure
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.
Measured: Baseline and 12 weeks
Change in clinic mean blood pressure
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).
Measured: Baseline and 12 weeks
change in fasting glucose
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.
Measured: Baseline and 12 weeks
change in total cholesterol
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.
Measured: Baseline and 12 weeks
change in HDL-cholesterol
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.
Measured: Baseline and 12 weeks
change in triglycerides
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start3 Mar 2024
- Primary completion30 Jun 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors Cardiovascular DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was characterized as an uncontrolled and pragmatic clinical trial, as it sought to establish a cause-and-effect relationship based on the object of study, its objective being explanatory and of an applied nature, allowing knowledge for practice and serving as an instrument for problem-solving.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Mendes Gerage, Universidade Federal de Santa Catarina
- Investigators
- Aline Mendes Gerage, PhD, Principal investigator, Federal University of Santa Catarina (UFSC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529158
- Sponsor's protocol ID
- PROCOR 2024.1
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory Prevention and Rehabilitation Program (PROCOR)
- ClinicalTrials.gov ID
- NCT07529158
- Acronym / sponsor ID
- PROCOR 2024.1
- Conditions
- Risk Factors Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 14 Apr 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was characterized as an uncontrolled and pragmatic clinical trial, as it sought to establish a cause-and-effect relationship based on the object of study, its objective being explanatory and of an applied nature, allowing knowledge for practice and serving as an instrument for problem-solving.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group 2 times per week | Experimental | Behavioral: PROCOR 2024.1The 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. |
| Exercise Group 3 times per week | Experimental | Behavioral: PROCOR 2024.1The 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| PROCOR 2024.1Aerobic 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. | Behavioural | Exercise Group 2 times per week, Exercise Group 3 times per week |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Change in clinic systolic blood pressure
Time frame: Baseline and 12 weeks
Change in clinic diastolic blood pressure
Time frame: Baseline and 12 weeks
Change in clinic mean blood pressure
Time frame: Baseline and 12 weeks
change in fasting glucose
Time frame: Baseline and 12 weeks
change in total cholesterol
Time frame: Baseline and 12 weeks
change in HDL-cholesterol
Time frame: Baseline and 12 weeks
change in triglycerides
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Aline Mendes Gerage, PhD principal investigator
Federal University of Santa Catarina (UFSC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROCOR 2024.1 in people with Risk Factors Cardiovascular Disease, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Apr 2026. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in strength (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. 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 14 Apr 2026.