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

NCT07529158 | Completed

• 1 other identifier: PROCOR 2024.1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Risk Factors Cardiovascular Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Change in clinic systolic blood pressure

  Baseline and 12 weeks

• Change in clinic diastolic blood pressure

  Baseline and 12 weeks

• Change in clinic mean blood pressure

  Baseline and 12 weeks

• change in fasting glucose

  Baseline and 12 weeks

• change in total cholesterol

  Baseline and 12 weeks

Study Arms (2)

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.

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.

Behavioral: PROCOR 2024.1

Interventions

PROCOR 2024.1 BEHAVIORAL

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.

Exercise Group 2 times per week; Exercise Group 3 times per week

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Sports Center - Federal University of Santa Catarina

Florianópolis, Santa Catarina, 88035-972, Brazil

Location

Study Officials

• Aline Mendes Gerage, PhD

  Federal University of Santa Catarina (UFSC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 14, 2026
• Study Start: March 3, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 15, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

BR (1)