High-Intensity Interval Training on Pre-Hypertensive Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03000140
• Date of registration: 17/12/2016
• Prospective Registration: No
• Primary sponsor: Universidad Santo Tomas
• Public title: High-Intensity Interval Training on Pre-Hypertensive Subjects
• Scientific title: Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects
• Date of first enrolment: March 2015
• Target sample size: 142
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03000140
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Chile

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hypertension

Metabolism Disorder

Intervention(s)

Behavioral: Control group

Behavioral: High Intensity Interval Training

Primary Outcome(s)

Change from Baseline in systolic blood pressure and diastolic blood pressure [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Secondary Outcome(s)

Change from Baseline in lipids [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Change from Baseline in fasting glucose [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Change from Baseline in one maximum repetition strength test of leg-extension exercise [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Change from Baseline in waist circumference [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Change from Baseline in fat mass [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Change from Baseline in body mass [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Change from Baseline in body mass index [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Change from Baseline in heart rate at rest [Time Frame: Baseline and 16 weeks immediately after the interventions ends]

Secondary ID(s)

Number 03052015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universidad del Rosario

University of Los Ríos

Healthcare Center Tomas Rojas

Universidad Pública de Navarra