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

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: Completed
• Conditions: Risk Factors Cardiovascular Disease
• Intervention / Treatment: Behavioral: PROCOR 2024.1

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	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.	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.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina
• Investigators: Principal Investigator: Aline Mendes Gerage, PhD, Federal University of Santa Catarina (UFSC)

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID 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