Post-exercise Hypotension After a Power Training Session in Older Adults With Hypertension

• ClinicalTrials.gov Identifier: NCT03615625
• Recruitment Status: Completed
• First Posted: August 6, 2018
• Last Update Posted: January 14, 2021
• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborator: Federal University of Rio Grande do Sul
• Information provided by (Responsible Party): Hospital de Clinicas de Porto Alegre

Study Description

Brief Summary:

The main purpose of the present study was to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension. As secondary outcomes, the investigators compared post-exercise hypotension, BP variability, and endothelial function between older men and women with hypertension.

The working hypothesis was that a single bout of power exercise would decrease both office and 24 h BP in comparison to a non-exercising control session and men and women would respond differently after a power training session.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Power Training Session	Not Applicable

Detailed Description:

Participants randomly performed two experimental sessions: power exercise training (PT) and non-exercising control at seated rest (Con). They maintained their current antihypertensive medications throughout the trial. Each session was composed of 20 min of rest in the supine position, 40 min of PT or Con protocols, and 60 min of rest in supine position after protocols. The PT was composed of 3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds. During the Con, the participants remained seated rest on the same exercise machines, but without any exercise. Standardized office BP was performed before and during the first hour (in intervals of 15 min) after exercise and control sessions. Together with the office BP evaluation in the pre and post sessions, the endothelium-dependent brachial vascular function was evaluated using Flow-mediated dilation. Afterwards, participants underwent 24h ambulatory BP monitoring..

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A randomized controlled clinical trial with crossover design was performed in order to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: The randomization list was generated by an epidemiologist using a computer software. This epidemiologist did not participate in the recruitment or assignment to the experimental sessions. Participants and the research team were blinded to the randomization list until the moment of assignment.
• Primary Purpose: Treatment
• Official Title: Effect of a Power Training Session on Ambulatory Blood Pressure in Older Adults With Hypertension: a Randomized Crossover Trial
• Actual Study Start Date: June 12, 2018
• Actual Primary Completion Date: July 20, 2019
• Actual Study Completion Date: January 1, 2020

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control session; Control session without any exercise. The participants remained in seated rest throughout 40 min
Experimental: Power Training Session; The power training session lasted 40 min, in which the participants performed a resistance exercise session using high velocity contractions during the exercises characterizing a power training session	Behavioral: Power Training Session; 3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds.

Outcome Measures

Primary Outcome Measures :

1. Ambulatory Blood Pressure Monitoring [ Time Frame: 24 hours after control and power training exercise session ]
   Mean 24-h, day-time, night-time of blood pressure in mmHg will be assessed after each experimental session (power training session and control session)

Secondary Outcome Measures :

1. Office Systolic Blood Pressure [ Time Frame: 60 minutes after control and power training exercise session ]
   Systolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout one hour
2. Office Diastolic Blood Pressure [ Time Frame: 60 minutes after control and power training exercise session ]
   Diastolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout one hour
3. Endothelial Function [ Time Frame: 60 minutes after control and power training exercise session ]
   Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography before and after each experimental session throughout one hour
4. Blood Pressure Variability [ Time Frame: 24 hours after control and power training exercise session ]
   Systolic and diastolic BP values obtained in the 24-hour ambulatory blood pressure monitoring, with valid measures included in a programmed software to calculate the average real variability of these measures.

Other Outcome Measures:

1. Sex Differences in Ambulatory Blood Pressure Monitoring, Office Blood Pressure, Endothelial Function and Blood Pressure Variability [ Time Frame: 60 minutes and 24 hours after control and power training exercise session ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively;
• Non-engaged in structured programs of exercise for the last 3 months since the beginning of this study;
• Able to perform the proposed exercises.

Exclusion Criteria:

• Underlying cardiovascular disease previously diagnosticated by a doctor, occurred in the last 24 months, such as: acute myocardial infarction, angina, stroke or heart failure;
• Diseases that reduce life expectancy;
• Smokers and ex-smokers for less than six months;
• BMI > 39.9 kg/m²
• diabetic proliferative retinopathy.

Contacts and Locations

Locations

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, RS, Brazil, 90035-903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Federal University of Rio Grande do Sul

Investigators

• Principal Investigator: Rodrigo Ferrari, PhD; Federal University of Rio Grande do Sul

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Oliveira Carpes L, Domingues LB, Schimitt R, Fuchs SC, Alhalimi T, Tanaka H, Ferrari R. Sex Differences in Post-exercise Hypotension, Ambulatory Blood Pressure Variability, and Endothelial Function After a Power Training Session in Older Adults. Front Physiol. 2021 Jul 16;12:657373. doi: 10.3389/fphys.2021.657373. eCollection 2021.

• Responsible Party: Hospital de Clinicas de Porto Alegre
• ClinicalTrials.gov Identifier: NCT03615625
• Other Study ID Numbers: 85210618.1.0000.5327
• First Posted: August 6, 2018
• Last Update Posted: January 14, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:

Exercise; Aging; Ambulatory Blood Pressure Monitoring; Power Exercise

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases