High-Intensity Interval Training on Pre-Hypertensive Subjects

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Metabolism Disorder, Hypertension

Intervention / Treatment
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* Behavioral: High Intensity Interval Training
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training<br>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<br>* 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.<br>|
| Active Comparator: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 16 weeks immediately after the interventions ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in body mass |  | Baseline and 16 weeks immediately after the interventions ends | 
| 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. | Baseline and 16 weeks immediately after the interventions ends | 
| Change from Baseline in waist circumference |  | Baseline and 16 weeks immediately after the interventions ends | 
| Change from Baseline in fat mass |  | Baseline and 16 weeks immediately after the interventions ends | 
| Change from Baseline in heart rate at rest | Baseline and 16 weeks immediately after the interventions ends | Baseline and 16 weeks immediately after the interventions ends | 
| Change from Baseline in fasting glucose |  | Baseline and 16 weeks immediately after the interventions ends | 
| Change from Baseline in lipids | 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 |  | Baseline and 16 weeks immediately after the interventions ends |