Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03064256
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2017-02-19
Brief Title:
Aerobic Physical Training and Heart Rate Variability in Hypertersion
Sponsor:
University of Campinas Brazil
Organization:
University of Campinas Brazil
Study Overview
Official Title:
EFFECT OF AEROBIC PHYSICAL TRAINING WITH DETERMINED INTENSITY FOR THE PROTOCOL OF DOUBLE EXHAUSTIVE EFFORTS IN THE AUTONOMICAL MODULATION OF THE HEART FREQUENCY OF PATIENTS WITH SYSTEMIC ARTERIAL HYPERTENSION
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compared the changes in the cardiovascular hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the protocol of double non-exhaustive efforts DENE with that of patients who received routine outpatient care 12 weeks after Entry into the study 63 men and women participated in the study and were allocated in the intervention group n 42 and control group n 21The following were performed Cardiopulmonary exercise test TECP for evaluation of peak oxygen consumption VO2peak oxygen pulse and double product DENE protocol for the determination of the intensity of the training It was obtained the recording of the intervals between consecutive heart beats iRR to evaluate the autonomic modulation of the heart rate Body mass index waist circumference AC hip circumference CQ and Waist hip ratio WHR were measured
Detailed Description:
The study was designed to compare changes in the cardiovascular hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the DENE protocol with that of patients who received routine ambulatory care 12 weeks after entering the study
Sixty-three hypertensive men and women divided into the intervention group GI n42 and the control group n 21 participated in the study
All procedures were performed by trained researchers and qualified staff and the evaluations and intervention were performed at the specialty medical outpatient clinic
After agreeing to participate in the study we collected sociodemographic and clinical data body mass index BMI waist circumference WC and waist hip ratio WHR The participants were submitted to the cardiopulmonary exercise test TECP to evaluate the peak oxygen consumption VO2peak oxygen pulse and double product Between one and seven days after TECP consecutive heart rate intervals iRR were recorded for evaluation of autonomic heart rate modulation using a Polar model RS800CX Polar Electro CoLtda Kempele Finland The DENE protocol for determining the intensity of the training was applied in the GI to determine the training intensity in the treadmill Intervention participants underwent supervised aerobic physical training at the pre-determined intensity which consisted of three weekly sessions lasting one hour over a period of 12 weeks Control participants receive routine care from the outpatient clinic for the same period At the end of the 12 weeks measures recording of the iRR intervals oxygen pulse double product BMI waist circumference AC hip circumference QC and waist hip ratio WHR were obtained All subjects were previously informed about the procedures Signed a free and informed consent form The project was approved by the Commission of Research Committee of the Institution with the number 086096 14
Sixty-three hypertensive men and women divided into the intervention group GI n42 and the control group n 21 participated in the study
All procedures were performed by trained researchers and qualified staff and the evaluations and intervention were performed at the specialty medical outpatient clinic
After agreeing to participate in the study we collected sociodemographic and clinical data body mass index BMI waist circumference WC and waist hip ratio WHR The participants were submitted to the cardiopulmonary exercise test TECP to evaluate the peak oxygen consumption VO2peak oxygen pulse and double product Between one and seven days after TECP consecutive heart rate intervals iRR were recorded for evaluation of autonomic heart rate modulation using a Polar model RS800CX Polar Electro CoLtda Kempele Finland The DENE protocol for determining the intensity of the training was applied in the GI to determine the training intensity in the treadmill Intervention participants underwent supervised aerobic physical training at the pre-determined intensity which consisted of three weekly sessions lasting one hour over a period of 12 weeks Control participants receive routine care from the outpatient clinic for the same period At the end of the 12 weeks measures recording of the iRR intervals oxygen pulse double product BMI waist circumference AC hip circumference QC and waist hip ratio WHR were obtained All subjects were previously informed about the procedures Signed a free and informed consent form The project was approved by the Commission of Research Committee of the Institution with the number 086096 14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None