NCT03615625

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.

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 hypertension

Timeline
Completed

Started Jun 2018

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

June 12, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

July 31, 2018

Last Update Submit

January 12, 2021

Conditions

Keywords

ExerciseAgingAmbulatory Blood Pressure MonitoringPower Exercise

Outcome Measures

Primary Outcomes (1)

  • Ambulatory Blood Pressure Monitoring

    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)

    24 hours after control and power training exercise session

Secondary Outcomes (4)

  • Office Systolic Blood Pressure

    60 minutes after control and power training exercise session

  • Office Diastolic Blood Pressure

    60 minutes after control and power training exercise session

  • Endothelial Function

    60 minutes after control and power training exercise session

  • Blood Pressure Variability

    24 hours after control and power training exercise session

Other Outcomes (1)

  • Sex Differences in Ambulatory Blood Pressure Monitoring, Office Blood Pressure, Endothelial Function and Blood Pressure Variability

    60 minutes and 24 hours after control and power training exercise session

Study Arms (2)

Control session

NO INTERVENTION

Control session without any exercise. The participants remained in seated rest throughout 40 min

Power Training Session

EXPERIMENTAL

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

Interventions

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.

Power Training Session

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HypertensionMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Rodrigo Ferrari, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 6, 2018

Study Start

June 12, 2018

Primary Completion

July 20, 2019

Study Completion

January 1, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations