NCT03112070

Brief Summary

Hypertension is the most prevalent cardiovascular disease risk factor among individuals 60 years of age and older. Hypertension can be prevented and modified with lifestyle interventions that include regular exercise. Water exercise is widely recommended for older adults for a variety of health benefits, but few studies have assessed the immediate ambulatory blood pressure (BP) response to water exercise, a response termed postexercise hypotension (PEH). We will assess PEH after a session of water aerobics in physically active, older women with hypertension. Twenty-four women will be randomly assign to participate in a 45 min session of moderate intensity, water aerobics (WATER) and a 45 min land control session (CONTROL). All experimental sessions will start at 9 am sharply with 7 days between them. Subjects will left the experiments wearing an ambulatory BP monitor for the next 21 hr.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

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

April 4, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

April 3, 2017

Last Update Submit

July 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure measurements

    BP measurements will take and monitored using a 24-hour ambulatory blood pressure monitoring (ABPM) protocol according to standard procedures. BP monitoring devices (Spacelab, Redmond, WA, USA) will be used to obtain BP over 21 hours that consiste of four measurements per hour over awake period (10 am to 10 pm) and two measurements per hour over sleep period (10 pm to 6 am). For data analysis we will calculate hourly averages for awake and sleep (during the same periods as mentioned above), and over 21 hours. SBP and DBP data are presente in two different manners: readings per hour during the day and the night periods, and the BP response determined as the difference (delta) between each hourly BP measurement from baseline after WATER compared to CONTROL.

    24-hour ambulatory blood pressure monitoring after water exercise

Study Arms (2)

Water aerobic exercise session (WATER)

EXPERIMENTAL

A continuous session of dynamic water aerobic exercise which consist of a dynamic warm-up period (5 minutes), an active exercise period (35 minutes), and a cooldown period (5 minutes) to total 45 minutes. Heart rate (HR) will be continuously measured with heart monitors (Polar) to confirm the intensity of the WATER session. The WATER intensity will be calculated according to the formula proposed by Kruel for exercise in an aquatic environment18 as follows: HR for exercise = % x (HRmax - ΔHR); % is the intensity of exercise; HRmax is the maximum HR (estimated by 220 - age); ΔHR represents the difference between resting HR on land and resting HR in the water environment. Exercise intensities: 55-60% HRmax during warm-up; 70-75% HRmax during active exercise; and 55-60% HRmax during cooldown.

Other: Water aerobic exercise session (WATER)

Control session (CONTROL)

NO INTERVENTION

A 45-min session with no exercise. During this session, participants will remain seated or standing as desired. They will read, talk, and drink water, but do nothing else.

Interventions

A continuous session of dynamic water aerobic exercise which consist of a dynamic warm-up period (5 minutes), an active exercise period (35 minutes), and a cooldown period (5 minutes) to total 45 minutes. Heart rate (HR) will be continuously measured with heart monitors (Polar) to confirm the intensity of the WATER session. The WATER intensity will be calculated according to the formula proposed by Kruel for exercise in an aquatic environment18 as follows: HR for exercise = % x (HRmax - ΔHR); % is the intensity of exercise; HRmax is the maximum HR (estimated by 220 - age); ΔHR represents the difference between resting HR on land and resting HR in the water environment. Exercise intensities: 55-60% HRmax during warm-up; 70-75% HRmax during active exercise; and 55-60% HRmax during cooldown.

Water aerobic exercise session (WATER)

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • resting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg documented by a physician;
  • to 80 years of age;
  • physically active on land but not water (exercising 3 or more days per week as determined by the International Physical Activity Questionnaire long-form).

You may not qualify if:

  • any febrile condition and/or infectious diseases;
  • no other chronic diseases or conditions other than hypertension;
  • body mass index (BMI) \> 35 kg/m2;
  • active smoker;
  • physical or mental limitations that prevent exercising.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandre Lehnen

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

Location

MeSH Terms

Conditions

Post-Exercise Hypotension

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

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 3, 2017

First Posted

April 13, 2017

Study Start

April 4, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

July 24, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations