Clinical trial NCT05135247: Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training
Official title: Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Dysfunction
Keywords: older individuals
heart rate variability
physical training
hypertension
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 61
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

Brief 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

Detailed 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)

Eligibility criteria: 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 β-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

Primary outcomes:
measure: Heart rate
timeFrame: 12 weeks
measure: Low frequency band
timeFrame: 12 weeks
measure: High frequency band
timeFrame: 12 weeks
measure: Entropy
timeFrame: 12 weeks
measure: Short term detrended fluctuation analysis
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: