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High-Intensity Interval Training on Pre-Hypertensive Subjects

Primary Purpose

Metabolism Disorder, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
High Intensity Interval Training
Control group
Sponsored by
Universidad Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolism Disorder

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cristian Alvarez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval Training

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline in systolic blood pressure and diastolic blood pressure
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2016
Last Updated
October 10, 2018
Sponsor
Universidad Santo Tomas
Collaborators
Healthcare Center Tomas Rojas, University of Los Ríos, Universidad Pública de Navarra, Universidad del Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT03000140
Brief Title
High-Intensity Interval Training on Pre-Hypertensive Subjects
Official Title
Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Santo Tomas
Collaborators
Healthcare Center Tomas Rojas, University of Los Ríos, Universidad Pública de Navarra, Universidad del Rosario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism Disorder, Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in systolic blood pressure and diastolic blood pressure
Description
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.
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Secondary Outcome Measure Information:
Title
Change from Baseline in body mass
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Title
Change from Baseline in body mass index
Description
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Title
Change from Baseline in waist circumference
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Title
Change from Baseline in fat mass
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Title
Change from Baseline in heart rate at rest
Description
Baseline and 16 weeks immediately after the interventions ends
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Title
Change from Baseline in fasting glucose
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Title
Change from Baseline in lipids
Description
Lipid profile (low-density cholesterol, total cholesterol, high-density cholesterol and triglycerides)
Time Frame
Baseline and 16 weeks immediately after the interventions ends
Title
Change from Baseline in one maximum repetition strength test of leg-extension exercise
Time Frame
Baseline and 16 weeks immediately after the interventions ends

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Cristian Alvarez
City
Osorno
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
30405426
Citation
Alvarez C, Ramirez-Campillo R, Cristi-Montero C, Ramirez-Velez R, Izquierdo M. Prevalence of Non-responders for Blood Pressure and Cardiometabolic Risk Factors Among Prehypertensive Women After Long-Term High-Intensity Interval Training. Front Physiol. 2018 Oct 23;9:1443. doi: 10.3389/fphys.2018.01443. eCollection 2018.
Results Reference
derived

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High-Intensity Interval Training on Pre-Hypertensive Subjects

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