NCT02415582

Brief Summary

The purpose of this study is to compare the effects of two exercise protocols on post-exercise blood pressure versus a control group in elderly hypertensive men. Participants are allocated to all groups: control group and two experimental exercise protocols, in a random order. In the control group, participants remain resting sitting, and, in the exercise protocols, participants practice exercise bouts of aerobic exercise or a combination of resistance and aerobic exercises. In order to standardize baseline conditions, before the sessions subjects remain sitting quietly for 20 minutes. After each exercise protocol, participants have 60 minutes for recovery and, simultaneously, they have BP measured every 5 minutes. After the exercise sessions or control, an equipment for 24 hours ambulatory BP monitoring is installed in every participant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2014

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

Study Start

First participant enrolled

March 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 31, 2018

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

April 9, 2015

Last Update Submit

May 29, 2018

Conditions

Keywords

HypertensionBloodpressurePost-exercise hypotensionCombined exerciseAerobic exerciseResistance exerciseAgingElderlyAmbulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • Ambulatory Blood Pressure Monitoring

    Ambulatory blood pressure monitoring following experimental protocols

    24 hours

Secondary Outcomes (1)

  • Office Blood Pressure

    1 hour

Study Arms (3)

Aerobic exercise

EXPERIMENTAL

Aerobic exercise on treadmill at 65-70% of the heart rate reserve during a session.

Other: Aerobic exercise

Combined exercises

EXPERIMENTAL

A session combines resistance and aerobic exercises, with aerobic exercise on treadmill at 65-70% of the heart rate reserve, followed by 60 minutes for cardiorespiratory recovery, and resistance exercise.

Other: Combined exercises

Control

SHAM COMPARATOR

Participants do not exercise and remain sitting for 45 minutes

Other: Control

Interventions

Aerobic exercise on treadmill

Aerobic exercise

Combined resistance and aerobic exercise

Combined exercises
ControlOTHER

45 minutes resting sitting

Control

Eligibility Criteria

Age60 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertension grade 1 - 2 with or without medical treatment:
  • resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg

You may not qualify if:

  • Smoking;
  • Bone, joint, or muscle problems that could limit the performance of the exercises.
  • BMI ≥ 30 kg/m2
  • Heart Attack in the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

HypertensionPost-Exercise Hypotension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotension

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sandra C Fuchs, PhD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 14, 2015

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 31, 2018

Record last verified: 2015-08

Locations