NCT04545034

Brief Summary

This randomized controlled trial aimed to determine the subacute blood pressure effects of pharmacologically-treated elderly hypertensive patients after a single session of water aerobic exercise.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
unknown

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

April 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

August 25, 2020

Last Update Submit

September 3, 2020

Conditions

Keywords

hypertensionwater aerobic exerciseelderlyblood pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure after water aerobic exercise in elderly hipertensive

    Blood pressure was measured with the patient seated using an internationally validated semi-automatic BP monitor (Omron 705-CP, Matsusaka, Japan) following techniques adopted by The Seventh Report \[1\]. BP was measured before the session (Pre); immediately after (Min-0) and every 10 minutes until 60 minutes after the protocols had been performed (Min-10, Min-20, Min-30, Min-40, Min-50 and Min-60). The measurements were repeated at 2-minute intervals and the calculation of the mean of the two measurements.

    Baseline response to 10 days

Study Arms (2)

Water aerobic exercise protocol

EXPERIMENTAL

Walter aerobic exercise session would be used to treat blood pressure in elderly hypertensive people.

Other: water aerobic exercise

Control Group

NO INTERVENTION

No exercise intervention would be used.

Interventions

The EP would be formed by continuous session of dynamic water aerobic exercise which consisted of a dynamic warm-up period (5 minutes), an active exercise period at the established intensity of HR (35 minutes), and a cooldown period (5 minutes) to total 45 minutes, with a intensity of 75%HR.

Water aerobic exercise protocol

Eligibility Criteria

Age65 Years - 85 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age between 65 and 85 years;
  • practice exercise (almost 3 days-week);
  • use of anti-hypertensive drugs;
  • systolic blood pressure (SBP) ≤160 mmHg and diastolic blood pressure (DBP) ≤100 mmHg documented by a physician

You may not qualify if:

  • body mass index (BMI) \>35 kg/m2;
  • decompensated diabetes mellitus and/or cardiac failure;
  • active smoker;
  • any febrile condition and/or infectious diseases;
  • cardiovascular event in the 3 months preceding the study;
  • hepatopathy;
  • physical or mental limitations that prevent exercising.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Universitário de Anápolis - UniEVANGÉLICA

Anápolis, Goiás, 75083-515, Brazil

Location

Raphael Martins Da Cunha

Goiânia, Goiás, 74275-160, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a randomized crossover clinical trial carried out with 25 hypertensive women. The study procedures took place over three days with an interval of 48 hours, and included evaluation session, an experimental protocol (EP) and a control protocol (CP).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 10, 2020

Study Start

April 1, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2021

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations