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Completed

NCT Number: NCT02415582

Post-Exercise Hypotension in Elderly Hypertensive Men

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.

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Key information

Age range

60 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas de Porto Alegre

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Aerobic Exercise

Other

Aerobic exercise on treadmill

Combined Exercises

Other

Combined resistance and aerobic exercise

Control

Other

45 minutes resting sitting

Primary outcomes

  1. Ambulatory Blood Pressure Monitoring

    Time frame: 24 hours

    Ambulatory blood pressure monitoring following experimental protocols

Secondary outcomes

  1. Office Blood Pressure

    Time frame: 1 hour

    Post exercise blood pressure during 60 minutes after experimental sessions

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

Effects of Different Exercises on Post-Exercise Blood Pressure in Elderly Hypertensive: A Cross-Over Randomized Clinical Trial

Acronym: HPE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2015
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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