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CompletedNCT02415582HPEUpdated May 31, 2018

Post-Exercise Hypotension in Elderly Hypertensive Men

An interventional study of Aerobic exercise and Combined exercises in Hypertension, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to male participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
60 Years to 70 Years
Sex
Male
01

Study 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.

Read the detailed description

Hypertension has high prevalence and low rate of control, and is a major modifiable risk factor and public health problem. Regular physical exercise is a relevant non-pharmacological option for prevention and treatment of hypertension. Several studies demonstrated a reduction in blood pressure (BP) following different exercise protocols, and the decrease may be the result of the summation of hypotensive effects that occur in the hours following the workout. The reduction resulting from a single exercise session is called post-exercise hypotension (PEH) and has been investigated among hypertensive subjects. However, to achieve clinical relevance the PEH should reach a significant magnitude and the reduction should be sustained for a longer period.

Previous studies showed the positive effects of aerobic exercise on post-exercise hypotension in hypertensive subjects. However, there is lacking evidence regarding the effects of a single session of aerobic and resistance exercise combined, and the duration of its effect in 24 hours blood pressure in elderly hypertensive subjects.

The study is an open, crossover randomized clinical trial, with elderly men allocated to three arms, in a random order:

  • Aerobic training session
  • Combined resistance training and aerobic session
  • Control session

After each exercise session, participants have 60 minutes for recovery, performed in the sitting position, with BP measurements every 5 minutes. In addition, participants have measured BP using 24h ambulatory BP monitoring. At the end of the trial, participants will have completed all three experimental protocols: a non-exercise control session, of sitting rest, and two exercise bouts, one of aerobic exercise and a combined resistance and aerobic exercise, with seven days of washout period among sessions. All experiments will be conducted at the same time of day to account for diurnal BP variation. Before the experimental sessions, participants are enrolled in three pre-intervention tests: a familiarization session, cardiopulmonary exercise testing and one maximum repetition strength test (1RM). The aerobic sessions last for 45 minutes, as well as the resistance exercises, and the session of control.

02

Conditions studied

  • Hypertension

Keywords

  • Hypertension
  • Bloodpressure
  • Post-exercise hypotension
  • Combined exercise
  • Aerobic exercise
  • Resistance exercise
  • Aging
  • Elderly
  • Ambulatory blood pressure monitoring
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 20 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Essential hypertension grade 1 - 2 with or without medical treatment:

resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg

Exclusion criteria

Exclusion Criteria:

  • Smoking;
  • Bone, joint, or muscle problems that could limit the performance of the exercises.
  • ≥ 30 kg/m2
  • Heart Attack in the last year
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Aerobic exercise

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

    Other: Aerobic exercise

  • Experimental
    Combined exercises

    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

  • Sham comparator
    Control

    Participants do not exercise and remain sitting for 45 minutes

    Other: Control

Interventions

  • OtherAerobic exercise

    Aerobic exercise on treadmill

  • OtherCombined exercises

    Combined resistance and aerobic exercise

  • OtherControl

    45 minutes resting sitting

06

What researchers measure

Primary outcomes

  1. Ambulatory Blood Pressure Monitoring

    Ambulatory blood pressure monitoring following experimental protocols

    Time frame: 24 hours

Secondary outcomes

  1. Office Blood Pressure

    Post exercise blood pressure during 60 minutes after experimental sessions

    Time frame: 1 hour

07

Study locations

1 site
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande Do Sul 90035-903, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02415582
Responsible party
Sponsor
First posted
Apr 14, 2015
Start date
Mar 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
May 31, 2018

Study contacts

Sandra C Fuchs, PhD
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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