NCT03254225

Brief Summary

This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability of hypertensive elderlies patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training, an the other will remain sedentary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

August 11, 2017

Last Update Submit

March 16, 2022

Conditions

Hypertension

Keywords

HypertensionElderlyResistance trainingHeart rate variability

Outcome Measures

Primary Outcomes (1)

  • Blood pressure change due to resistance training

    Blood pressure will be measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.

    16 weeks

Secondary Outcomes (3)

  • Heart rate variability - Time domain - change due to resistance training

    16 weeks

  • Heart rate variability - Frequency domain - change due to resistance training

    16 weeks

  • Heart rate variability - Non-linear methods - change due to resistance training

    16 weeks

Study Arms (2)

Resistance training

EXPERIMENTAL

Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).

Behavioral: Resistance training

Control

NO INTERVENTION

in this arm, the group will remain sedentary for the same period of the experimental group, and they will be invited to engage on the raining program after the sedentary period

Interventions

Resistance trainingBEHAVIORAL

Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).

Resistance training

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertensives
  • Age 60 to 80 years
  • Nonactive

You may not qualify if:

  • Orthopedic problems or other problem that prevented the exercises
  • Change in drug treatment during protocol
  • Absence in more than 25% of the exercise sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabio Tanil Montrezol

Santos, São Paulo, 11070061, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fabio T Montrezol

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 18, 2017

Study Start

April 4, 2018

Primary Completion

January 30, 2020

Study Completion

April 30, 2021

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)