NCT05135247

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

November 9, 2021

Last Update Submit

November 19, 2021

Conditions

Keywords

older individualsheart rate variabilityphysical traininghypertension

Outcome Measures

Primary Outcomes (5)

  • Heart rate

    Heart rate was obtained before and after the protocol by electrocardiogram, performed before and after tilt test at each time.

    12 weeks

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

continuous aerobic training (CA)

EXPERIMENTAL

The CA group was trained with 70% of maximum heart rate (MHR) for 30 minutes.

Other: Exercise

resistance training (R)

EXPERIMENTAL

The R sessions consisted of a set of each proposed exercise: sitting bench press, legpress, back row, leg extension, shoulders high pull, seated leg curl, biceps curls, standing calf, triceps in the pulley, and abdominal crunches, with 8 - 10 repetitions with 75% 1MR.

Other: Exercise

interval aerobic training (IA)

EXPERIMENTAL

The IA group was submitted to exercise intensities of 60% for 2 minutes and 80% for 2 minutes, alternately, with a total of 30 minutes.

Other: Exercise

control (C)

NO INTERVENTION

Individuals in the control group maintained their usual activities.

Interventions

3 different types of training or control

continuous aerobic training (CA)interval aerobic training (IA)resistance training (R)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Primary DysautonomiasHypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 26, 2021

Study Start

January 10, 2015

Primary Completion

June 10, 2017

Study Completion

July 10, 2017

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

Individual data of volunteers, without identification, can be provided if requested by other authors, through contact with the main researcher

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be made available after the publication of the study, with no time to end sharing
Access Criteria
contact with the main researcher