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CompletedNCT07529158Updated Apr 14, 2026

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

An interventional study of PROCOR 2024.1 in Risk Factors Cardiovascular Disease, sponsored by Universidade Federal de Santa Catarina. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Universidade Federal de Santa Catarina · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Mar 2024, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Sex
All
01

Study 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. 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.

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Conditions studied

  • Risk Factors Cardiovascular Disease
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In context

Lead sponsor

Universidade Federal de Santa Catarina is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralPROCOR 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

  2. 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.

    Time frame: Baseline and 12 weeks

  3. 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.

    Time frame: Baseline and 12 weeks

  4. 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.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

  2. 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.

    Time frame: Baseline and 12 weeks

  3. 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).

    Time frame: Baseline and 12 weeks

  4. 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.

    Time frame: Baseline and 12 weeks

  5. 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.

    Time frame: Baseline and 12 weeks

  6. 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.

    Time frame: Baseline and 12 weeks

  7. 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.

    Time frame: Baseline and 12 weeks

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Study locations

1 site
  • Sports Center - Federal University of Santa Catarina
    Florianópolis, Santa Catarina 88035-972, Brazil
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07529158
Lead sponsor
Universidade Federal de Santa Catarina
Responsible party
Aline Mendes Gerage (Principal Investigator, Universidade Federal de Santa Catarina) — Principal investigator
First posted
Apr 14, 2026
Start date
Mar 3, 2024
Primary completion
Jun 30, 2024
Completion
Dec 15, 2024
Last update
Apr 14, 2026

Study contacts

Aline Mendes Gerage, PhD
principal investigator · Federal University of Santa Catarina (UFSC)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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