High-Intensity Interval Training on Pre-Hypertensive Subjects

Sponsor
Universidad Santo Tomas (Other)
Overall Status
Completed
CT.gov ID
NCT03000140
Collaborator
Healthcare Center Tomas Rojas (Other), University of Los Ríos (Other), Universidad Pública de Navarra (Other), Universidad del Rosario (Other)
142
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2
23.1
6.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High Intensity Interval Training
  • Behavioral: Control group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
142 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Change from Baseline in body mass [Baseline and 16 weeks immediately after the interventions ends]

  2. 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.

  3. Change from Baseline in waist circumference [Baseline and 16 weeks immediately after the interventions ends]

  4. Change from Baseline in fat mass [Baseline and 16 weeks immediately after the interventions ends]

  5. 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

  6. Change from Baseline in fasting glucose [Baseline and 16 weeks immediately after the interventions ends]

  7. 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)

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cristian Alvarez Osorno Chile

Sponsors and Collaborators

  • Universidad Santo Tomas
  • Healthcare Center Tomas Rojas
  • University of Los Ríos
  • Universidad Pública de Navarra
  • Universidad del Rosario

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidad Santo Tomas
ClinicalTrials.gov Identifier:
NCT03000140
Other Study ID Numbers:
  • Number 03052015
First Posted:
Dec 21, 2016
Last Update Posted:
Oct 11, 2018
Last Verified:
Oct 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2018