Effect of Exercise on Endothelial Injury in Hypertensive Patients

NCT ID: NCT02937922

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-01-31

Brief Summary

Introduction: Endothelial dysfunction precedes atherosclerosis being evidenced in patients with hypertension. Increasing physical activity levels and/or physical exercise are part of the recommendations of antihypertensive therapy. However, the effects of oscillations and/or increase the systemic blood pressure induced by exercise session on endothelial function has not been studied.

Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined exercise on endothelial injury levels in patients with hypertension.

Methodology: Hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40 minutes of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of one repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20 minutes of resistance exercise and 20 minutes of aerobic exercise, in that order). Blood will be collected 10 minutes before, 10 and 60 minutes after intervention for the quantification of endothelial microparticles (MPE) circulating (induced endothelial lesion) and endothelial progenitor cells (EPC) circulating (endothelial recovery capacity) by flow cytometry. Ambulatory blood pressure monitoring (ABPM) will be held before and after the intervention. Ultrasonography is used to measure the flow-mediated dilation of the brachial artery 10 minutes before, 10, 30 and 60 minutes after the intervention.

Statistics: generalized estimating equation (GEE) for repeated measurements and Person correlation, being significant p < 0.05.

It is expected to show results to ensure cardiovascular protection in patients with hypertension caused by different types of exercise and consequent endothelial injury and release induced regenerative factors. Knowledge of the magnitude of injury and endothelial recovery provided by different types of exercise can contribute scientifically to health professionals aimed at prescribing exercise with a vascular protective vision in patients with hypertension.

Conditions

Hypertension; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

AEROBIC

The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: \[(HR max - HR rest) x desired intensity\] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.

Group Type: ACTIVE_COMPARATOR

AEROBIC

Intervention Type: OTHER

The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: \[(HR max - HR rest) x desired intensity\] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.

RESISTANCE

The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60% of a maximum repetition (1-RM) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).

Group Type: ACTIVE_COMPARATOR

RESISTANCE

Intervention Type: OTHER

The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60 % of a maximum repetition (1-RM) (moderate intensity) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).

COMBINED

The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.

Group Type: ACTIVE_COMPARATOR

COMBINED

Intervention Type: OTHER

The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise, resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.

Interventions

AEROBIC

The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: \[(HR max - HR rest) x desired intensity\] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.

Intervention Type: OTHER

RESISTANCE

The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60 % of a maximum repetition (1-RM) (moderate intensity) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).

Intervention Type: OTHER

COMBINED

The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise, resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.

Intervention Type: OTHER

Other Intervention Names

Aerobic exercise; Resistance exercise; Combined exercise

Eligibility Criteria

Inclusion Criteria

• Adults with hypertension;
• 30 to 59 years old.

Exclusion Criteria

• Diabetes;
• Heart disease;
• Participating in any regular exercise program over the last six months;
• Orthopedic impairments or any physical or mental limitation that prevents - achievement of physical exercise;
• Body Mass Index in class II obesity or more (BMI ≥ 35 kg / m2);
• Smoking.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Waclawovsky

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Waclawovsky G, Umpierre D, Figueira FR, De Lima ES, Alegretti AP, Schneider L, Matte US, Rodrigues TC, Schaan BD. Exercise on Progenitor Cells in Healthy Subjects and Patients with Type 1 Diabetes. Med Sci Sports Exerc. 2016 Feb;48(2):190-9. doi: 10.1249/MSS.0000000000000764.

Reference Type: BACKGROUND

PMID: 26312614 (View on PubMed)

Amabile N, Cheng S, Renard JM, Larson MG, Ghorbani A, McCabe E, Griffin G, Guerin C, Ho JE, Shaw SY, Cohen KS, Vasan RS, Tedgui A, Boulanger CM, Wang TJ. Association of circulating endothelial microparticles with cardiometabolic risk factors in the Framingham Heart Study. Eur Heart J. 2014 Nov 7;35(42):2972-9. doi: 10.1093/eurheartj/ehu153. Epub 2014 Apr 16.

Reference Type: BACKGROUND

PMID: 24742886 (View on PubMed)

Other Identifiers

Endothelial

Identifier Type: -

Identifier Source: org_study_id