Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03254225

Collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)

Enrollment

Location

Arms

36.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Resistance training	N/A

Detailed Description

This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability using time and frequency-domains by ECG tracks. Will be assessed the blood pressure using the ambulatory blood pressure monitoring method of hypertensive elderly patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal repetition, an the ontrol group will remain sedentary.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability

Actual Study Start Date :

Apr 4, 2018

Actual Primary Completion Date :

Jan 30, 2020

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resistance training 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 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).
No Intervention: Control 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

Arm

Intervention/Treatment

Experimental: Resistance training

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

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).

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Blood pressure change due to resistance training [16 weeks]
Blood pressure will be measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.

Secondary Outcome Measures

Heart rate variability - Time domain - change due to resistance training [16 weeks]
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
Heart rate variability - Frequency domain - change due to resistance training [16 weeks]
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
Heart rate variability - Non-linear methods - change due to resistance training [16 weeks]
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hypertensives
Age 60 to 80 years
Nonactive

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fabio Tanil Montrezol	Santos	Sao Paulo	Brazil	11070061

Sponsors and Collaborators

Federal University of São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

Principal Investigator: Fabio T Montrezol, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alessandra Medeiros, Principal Investigator, Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT03254225

Other Study ID Numbers:

CEP1844640

First Posted:

Aug 18, 2017

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alessandra Medeiros, Principal Investigator, Federal University of São Paulo

Hypertension

Elderly

Resistance training

Heart rate variability

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Mar 17, 2022