High-Intensity Interval Training on Pre-Hypertensive Subjects

October 10, 2018 updated by: Universidad Santo Tomas

Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects

Despite exercise training decrease blood pressure in 'average' terms, there is a wide interindividual variability after exercise training, being yet unknown what mode of exercise (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some outcome).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite exercise training decrease blood pressure in 'average' terms, there is a wide interindividual variability after exercise training, being yet unknown what mode of exercise (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some outcome).

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Osorno, Chile
        • Cristian ALvarez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Written informed consent;
  • Interested in improving health and fitness;
  • Systolic blood pressure > 120 mmHg and < 140 mmHg, and/or DBP ≥ 80 and < 90 mmHg according with standard classification;
  • No drug therapy during the previous 3 months;
  • Body mass index (BMI) 25 and 35 kg/m2); (c) physically inactive (according to the International Physical Activity Questionnaire previously validated in Chilean population)
  • Normal /mild altered lipid profile (total cholesterol [TC] ~200 and ≤250 mg/dL, low-density lipids [LDL-C] ~140 mg/dL and ≤200 mg/dL, high-density lipids [HDL-C] ≥20 and ~40 mg/dL, triglycerides ~150 and ≤250 mg/dL) according with standard classification.

Exclusion Criteria:

  • Cardiovascular contraindications to exercise histories of stroke;
  • Asthma and chronic obstructive pulmonary disease;
  • Musculoskeletal disorder such as low back pain;
  • Smokers in the last 3 months were not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High Intensity Interval Training
Cycling on cycle ergometers (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) for 1 min at a subjective intensity of 8-10 points of the modified Borg scale of 1-10 points, and interspersed by inactive (without movement over the bicycle) of 2 minutes as recovery period.
Behavioral: High Intensity Interval Training
High Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.
ACTIVE_COMPARATOR: Control group
Pre-hypertensive group was compared with healthy groups in the 2 manin variables systolic/diastolic blood pressure, as well as in other co-variables in pre-post changes. Thus, after the training intervention, and following the R and NR classification, we will compare the NR prevalence between both Pre-hypertensive and Healthy group.
Behavioral: Control group
Moderade Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in systolic blood pressure and diastolic blood pressure
Time Frame: Baseline and 16 weeks immediately after the interventions ends
After this, we calculated the delta changes in both variables and classified to all subjects in responders (R) and non-responders (NR) to decrease systolic or diastolic blood pressure.
Baseline and 16 weeks immediately after the interventions ends

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in body mass
Time Frame: Baseline and 16 weeks immediately after the interventions ends
Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in body mass index
Time Frame: Baseline and 16 weeks immediately after the interventions ends
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in waist circumference
Time Frame: Baseline and 16 weeks immediately after the interventions ends
Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in fat mass
Time Frame: Baseline and 16 weeks immediately after the interventions ends
Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in heart rate at rest
Time Frame: Baseline and 16 weeks immediately after the interventions ends
Baseline and 16 weeks immediately after the interventions ends
Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in fasting glucose
Time Frame: Baseline and 16 weeks immediately after the interventions ends
Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in lipids
Time Frame: Baseline and 16 weeks immediately after the interventions ends
Lipid profile (low-density cholesterol, total cholesterol, high-density cholesterol and triglycerides)
Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of leg-extension exercise
Time Frame: Baseline and 16 weeks immediately after the interventions ends
Baseline and 16 weeks immediately after the interventions ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Santo Tomas

Collaborators

Universidad Pública de Navarra
Universidad del Rosario
Healthcare Center Tomas Rojas
University of Los Ríos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

December 17, 2016

First Submitted That Met QC Criteria

December 17, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Number 03052015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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