High-Intensity Interval Training on Pre-Hypertensive Subjects

NCT03000140 | Completed DMC

• 1 other identifier: Number 03052015
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolism Disorder; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from Baseline in body 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

• 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 heart rate at rest

  Baseline and 16 weeks immediately after the interventions ends

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

High Intensity Interval Training BEHAVIORAL

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.

High Intensity Interval Training

Control group BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cristian Alvarez

Osorno, Chile

Location

Related Publications (1)

• 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.

  PMID: 30405426 DERIVED

MeSH Terms

Conditions

Metabolic Diseases; Hypertension

Interventions

High-Intensity Interval Training; Control Groups

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: December 21, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

CL (1)