Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training

Autonomic Dysfunction Clinical Trial

Official title:

Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05135247
• Other study ID #: 1.092.824
• Status: Completed
• Phase: N/A
• Start date: January 10, 2015
• Est. completion date: July 10, 2017

Study information

• Verified date: November 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sixty-one sedentary older hypertensive individuals were randomized to four groups: continuous aerobic training (CA), interval aerobic training (IA), resistance training (R), and control (C) group. The protocol included 3 sessions of training by week for 12 weeks. C individuals were instructed to continue their usual activities. They were submitted to the passive tilt test before and after the research protocol, evaluating the heart rate (HR), low frequency (LF) and high frequency (HF) bands, detrended fluctuation analysis (DFAα1) and entropy

Description:

The individuals were randomized into four groups: continuous aerobic training (CA), interval aerobic training (IA), resistance training (R), and control (C), which performed physical exercises three times a week for twelve weeks, with a total of 36 sessions. The tilt test was performed before and after the research protocol. Individuals in the control group were only encouraged to maintain their usual activities.

For the analysis of HRV, the baseline conditions (resting in the supine position) were determined, followed by the passive postural maneuver, which characterizes the tilt test (table til tat 70 °) in order to determine the following variables:

• HR: heart rate (sympathetic action)

• LF: Low frequency band (Modulated predominantly by the sympathetic system)

• HF: High frequency band (Modulated predominantly by the parasympathetic system)

• Entropy: data complexity or irregularity index showing that, the higher the values, the better the HRV.

• DFAα1 (short term detrended fluctuation analysis)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 10, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:men and women 60-year-old or older, extensively using prescription antihypertensive drugs, and having no previous experience with physical training -

Exclusion Criteria:

• • Positive treadmill test (TT) for ischemia

• Related left ventricular systolic dysfunction of any degree

• Presence of arrhythmias

• Use of ß-blockers

• Use more than seven doses of ethyl alcohol per week

• Renal insufficiency

• Diabetes

• Hyper- or hypothyroidism

• Limiting lung disease

• Osteomioarticular impairment that would limit exercise performance

• SBP =160 and/or DBP = 100 mmHg on baseline

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Primary Dysautonomias

Intervention

Other:
• Exercise
3 different types of training or control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.	12 weeks
Primary	Low frequency band	Low frequency band was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks
Primary	High frequency band	High frequency band was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks
Primary	Entropy	Entropy was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks
Primary	Short term detrended fluctuation analysis	Short term detrended fluctuation analysis obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.The electrical signal from the electrocardiogram was filtered and amplified. The amplified signals were processed by ananalog-digital converter (DI-720, DATAQ Instruments, Akron, OH, USA) and sampled (1000 hz per channel) by a computer program (Windaq, DATAQ, Akron, OH, USA) installed in an IBM/PC computer.	12 weeks