High-Intensity Interval Training on Pre-Hypertensive Subjects

Not Applicable

Completed

• Conditions: Hypertension; Metabolism Disorder
• Interventions: Behavioral: High Intensity Interval Training; Behavioral: Control group

• Registration Number: NCT03000140
• Lead Sponsor: Universidad Santo Tomas

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).

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-17
• Study First Submitted QC: 2016-12-17
• Study First Posted: 2016-12-21
• Study Completion: 2017-02
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Interval Training	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in systolic blood pressure and diastolic blood pressure	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.

Secondary Outcome Measures

Name	Time	Method
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 body mass index	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.
Change from Baseline in body mass	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
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	Baseline and 16 weeks immediately after the interventions ends	Lipid profile (low-density cholesterol, total cholesterol, high-density cholesterol and triglycerides)

Trial Locations

Locations (1)

Cristian Alvarez; 🇨🇱 Osorno, Chile