High-Intensity Interval Training on Pre-Hypertensive Subjects

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000140
• Other study ID #: Number 03052015
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: Universidad Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Metabolic Diseases
• Metabolism Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Chile	Cristian Alvarez	Osorno

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Santo Tomas	Healthcare Center Tomas Rojas, Universidad del Rosario, Universidad Pública de Navarra, University of Los Ríos

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in body mass		Baseline and 16 weeks immediately after the interventions ends
Secondary	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
Secondary	Change from Baseline in waist circumference		Baseline and 16 weeks immediately after the interventions ends
Secondary	Change from Baseline in fat mass		Baseline and 16 weeks immediately after the interventions ends
Secondary	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
Secondary	Change from Baseline in fasting glucose		Baseline and 16 weeks immediately after the interventions ends
Secondary	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
Secondary	Change from Baseline in one maximum repetition strength test of leg-extension exercise		Baseline and 16 weeks immediately after the interventions ends