The Effect Of High Intensity Interval Training And Moderate Intensity Continuous Training In Patients With Hypertension

May 10, 2024 updated by: Nurdan Metin, Ankara City Hospital Bilkent

The Effect Of High Intensity Interval Training And Moderate Intensity Continuous Training On Cardiopulmonary Parameters And Clinical Findings In Patients With Hypertension:A Randomized Comparative Study

Comparison of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) in patients with hypertension patient in terms of aerobic capacity, blood pressure level, anxiety and depression scores, quality of life, kinesiophobia levels and sleep quality measurement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about study and potential risks, all patients giving written informed consent will undergo screening period determine eligibility for study entry. The patients who met the eligibility recruitments will get into the assessment. The study will include 38 participants (19 HIIT and 19 MICT). Stratified randomization method will be preferred in this study.A total of 38 patients with primary hypertension will be included in the study to evaluate the effect of different intensities of aerobic exercise on cardiopulmonary parameters, aerobic capacity, blood pressure level, anxiety and depression scores, quality of life, kinesiophobia levels and sleep quality.The researcher will record demographic and clinical data of the patients.All patients will be randomly divided into two groups as MICT (n=19) and HIIT (n=19) group. All patients will be evaluated with BDI (Beck Depression Inventory), BAI (Beck Anxiety Inventory), SF-36 (Short Form-36), KCS (Kinesiophobia Causes Scalae), PSQI (Pittsburgh Sleep Quality Index) before starting the rehabilitation program. Cardiopulmonary exercise test (CPET) will be performed to analyze the cardiopulmonary parameters and determine exercise capacity of the patients.The exercise prescription will be tailored in two different intensities according to the VO2 max (maximum oxygen uptake) values of the patients (HIIT and MICT).For determination of exercise intensity, KPET will be applied to all patients using the Sentry Suite Version 2.19 program with the device (CareFusion Type Master Screen PFT, Serial no: 672819, Germany) at Ankara Bilkent City Hospital. Moderate intensity will be calculated based on load (watt) at % 50-60 of VO2 max, high intensity will be calculated based on load (watt) at % 75-85 of VO2 max analyzed during the CPET. The aerobic exercise program will be performed with a horizontal ergometric bicycle for 3 sessions per week, each session being 30 minutes, for a total of 12 sessions for 4 weeks in the cardiopulmonary rehabilitation laboratory. At the end of the rehabilitation program, all these parameters will be re-evaluated and analyzed in the two groups and the two groups will be compared in terms of these parameters.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with Isolated Hypertension
  • Being cognitively competent
  • Being between the ages of 35-55
  • Having given informed consent to participate in the study.

Exclusion Criteria:

  • Clinical heart failure
  • Uncontrolled hypertension
  • Secondary hypertension
  • Moderate or severe pulmoner disease
  • Symptomatic peripheral arterial disease
  • Unstable arrhythmia
  • Unstable or severe angina
  • Moderate or severe valvular heart disease
  • Cognitive limitation unable to understand the research protocol
  • Pace maker presence
  • Language problem
  • Autonomic neuropathy
  • Cardiomyopathy
  • Congenital heart disease
  • Recent history of stroke
  • Diabetes mellitus
  • Severe musculoskeletal disease causing exercise limitation
  • Being unable to continue treatment (3 days a week for 4 weeks)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High intensity interval training (HIIT)
Patients will receive high intensity interval training (HIIT).
Other: High intensity interval training
High intensity will be calculated based on load (watt) at % 75-85 of VO2 max analyzed during the CPET in HIIT group.Patients will perform 4 minutes of active high-intensity training with this load. Patients will perform for 1 minute each with a load (watt) of 50-60% of VO2 max in the interval phase.HIIT program will be performed with a horizontal ergometric bicycle (Ergoline GmbH ergoselect5, Serial no:2020010104, Germany ) for 3 sessions per week, each session being 30 minutes, for a total of 12 sessions for 4 weeks in the cardiopulmonary rehabilitation laboratory.
Active Comparator: Moderate intensity (MICT)
Patients will receive moderate intensity continuous training (MICT).
Other: Moderate intensity continuous training
Moderate intensity will be calculated based on load (watt) at % 50-60 of VO2 max analyzed during the CPET in MICT group. Patients will complete their training sessions without changing this load determined during the treatment process.MICT program will be performed with a horizontal ergometric bicycle (Ergoline GmbH ergoselect5, Serial no:2020010104, Germany ) for 3 sessions per week, each session being 30 minutes, for a total of 12 sessions for 4 weeks in the cardiopulmonary rehabilitation laboratory.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aerobic capasity
Time Frame: baseline and at 4rd weeks
The aim of this study was to demonstrate the effects of aerobic exercise on aerobic capacity in patients with hypertension.The primary outcome is the change in maksimum oxygen consumption (VO2 max: mL.kg-1.min-1) between baseline and week 4 measured during CPET. Aerobic capacity is a measure of the functional capacity of the cardiorespiratory system and can be expressed as VO2 max (ml O2/kg/min). VO2 max is the amount of oxygen consumed in milliliters per kilogram per minute. The most accurate and reliable measure of aerobic capacity is the measurement of maximum oxygen consumption (VO2 max), which is the maximum volume of oxygen the body can take up and use during exercise. An increase in VO2 max is the most reliable method of demonstrating the effect of exercise.
baseline and at 4rd weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurdan Metin, M.D, Ankara Bilkent City Hospital
  • Study Director: Nilüfer Kutay Ordu Gökkaya, M.D, Health Sciences University, Ankara Bilkent City Hospital
  • Study Chair: Ebru Alemdaroğlu, M.D, Health Sciences University, Ankara Bilkent City Hospital
  • Study Chair: Emre Aruğaslan, M.D, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • nurdan.mtn

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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