Clinical trial NCT03000140: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism Disorder
Hypertension
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Healthcare Center Tomas Rojas
name: University of Los Ríos
name: Universidad Pública de Navarra
name: Universidad del Rosario
First posted: 2016-12-21
Enrollment: 142
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Change from Baseline in systolic blood pressure and diastolic blood pressure
timeFrame: Baseline and 16 weeks immediately after the interventions ends
Secondary outcomes:
measure: Change from Baseline in body mass
timeFrame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in body mass index
timeFrame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in waist circumference
timeFrame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in fat mass
timeFrame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in heart rate at rest
timeFrame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in fasting glucose
timeFrame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in lipids
timeFrame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of leg-extension exercise
timeFrame: Baseline and 16 weeks immediately after the interventions ends
Other outcomes:
Locations:
city: Osorno
country: Chile
facility: Cristian Alvarez
Study officials:
References:
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.