NCT02987452

Brief Summary

Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive (RHTN) patients, have not been investigated yet.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2017

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

December 6, 2016

Last Update Submit

December 13, 2016

Conditions

Keywords

exerciseresistant hypertensionblood pressure

Outcome Measures

Primary Outcomes (1)

  • systolic blood pressure in mmHg

    systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.

    15 minutes

Secondary Outcomes (5)

  • arterial stiffness

    baseline and 60 minutes post each intervention

  • ambulatory blood pressure monitoring

    baseline and post each intervention

  • interleukin 6

    baseline, 60 minutes and 24 hours post each intervention

  • interleukin 10

    baseline, 60 minutes and 24 hours post each intervention

  • tumor necrosis factor alpha

    baseline, 60 minutes and 24 hours post each intervention

Study Arms (3)

aerobic exercise

EXPERIMENTAL

Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test

Other: aerobic exerciseOther: resistance exerciseOther: combined exercise

resistance exercise

ACTIVE COMPARATOR

resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes

Other: aerobic exerciseOther: resistance exerciseOther: combined exercise

combined exercise

ACTIVE COMPARATOR

combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes

Other: aerobic exerciseOther: resistance exerciseOther: combined exercise

Interventions

Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test

aerobic exercisecombined exerciseresistance exercise

resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes

aerobic exercisecombined exerciseresistance exercise

combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes

aerobic exercisecombined exerciseresistance exercise

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the diagnosis recommended by the AHA Statement on Resistant Hypertension (2008)
  • a 6-month period clinic follow-up
  • give written informed consent form

You may not qualify if:

  • secondary Hypertension
  • pseudoresistance hypertension (poor medication adherence and white coat hypertension)
  • patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases, heart failure
  • pregnant women
  • smoking
  • regular physical activity
  • mental or physical limitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fraccari-Pires N, Coelho-Junior HJ, Gambassi BB, Cabral de Faria AP, Ritter AMV, Gasparetti CS, Pioli MR, Ruberti OM, Ferreira-Melo SE, Moreno H, Rodrigues B. Cardiovascular Autonomic Responses to Aerobic, Resistance and Combined Exercises in Resistance Hypertensive Patients. Biomed Res Int. 2022 Apr 20;2022:8202610. doi: 10.1155/2022/8202610. eCollection 2022.

MeSH Terms

Conditions

HypertensionMotor Activity

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Nayara F. Pires, PhD student

    University of Campinas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayara F. Pires, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 9, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

December 14, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share