Risk Factors Cardiovascular Disease
Conditions
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.
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.
Sponsors
Universidade Federal de Santa Catarina
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in strength | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinic systolic blood pressure | 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. |
| Change in clinic diastolic blood pressure | 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. |
| Change in clinic mean blood pressure | 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). |
| change in fasting glucose | 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. |
| change in total cholesterol | 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. |
| change in HDL-cholesterol | 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. |
| change in triglycerides | 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. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORAline Mendes Gerage, PhD
Federal University of Santa Catarina (UFSC)
Outcome results
None listed