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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

38

Phase

  • 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 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

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
Intervention / Treatment
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

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

Ankara City Hospital Bilkent

Investigators

  • 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)

April 15, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

April 5, 2024

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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