NCT06243224

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

January 13, 2024

Last Update Submit

May 10, 2024

Conditions

HypertensionLife Style

Keywords

Aerobic trainingHypertensionAerobic capasity

Outcome Measures

Primary Outcomes (1)

  • Aerobic capasity

    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

Study Arms (2)

High intensity interval training (HIIT)

ACTIVE COMPARATOR

Patients will receive high intensity interval training (HIIT).

Other: High intensity interval training

Moderate intensity (MICT)

ACTIVE COMPARATOR

Patients will receive moderate intensity continuous training (MICT).

Other: Moderate intensity continuous training

Interventions

High intensity interval trainingOTHER

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.

High intensity interval training (HIIT)
Moderate intensity continuous trainingOTHER

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.

Moderate intensity (MICT)

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Gorostegi-Anduaga I, Corres P, MartinezAguirre-Betolaza A, Perez-Asenjo J, Aispuru GR, Fryer SM, Maldonado-Martin S. Effects of different aerobic exercise programmes with nutritional intervention in sedentary adults with overweight/obesity and hypertension: EXERDIET-HTA study. Eur J Prev Cardiol. 2018 Mar;25(4):343-353. doi: 10.1177/2047487317749956. Epub 2018 Jan 9.

    PMID: 29313359RESULT

  • Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimaraes GV. Effects of high-intensity aerobic interval training vs. moderate exercise on hemodynamic, metabolic and neuro-humoral abnormalities of young normotensive women at high familial risk for hypertension. Hypertens Res. 2010 Aug;33(8):836-43. doi: 10.1038/hr.2010.72. Epub 2010 May 7.

    PMID: 20448634RESULT

  • Williams B, Mancia G, Spiering W, Rosei EA, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I. [2018 ESC/ESH Guidelines for the management of arterial hypertension]. Kardiol Pol. 2019;77(2):71-159. doi: 10.5603/KP.2019.0018. No abstract available. Polish.

    PMID: 30816983RESULT

MeSH Terms

Conditions

Hypertension

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nurdan Metin, M.D

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

  • Nilüfer Kutay Ordu Gökkaya, M.D

    Health Sciences University, Ankara Bilkent City Hospital

    STUDY DIRECTOR

  • Ebru Alemdaroğlu, M.D

    Health Sciences University, Ankara Bilkent City Hospital

    STUDY CHAIR

  • Emre Aruğaslan, M.D

    Ankara City Hospital Bilkent

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)

Study Record Dates

First Submitted

January 13, 2024

First Posted

February 6, 2024

Study Start

April 15, 2023

Primary Completion

February 15, 2024

Study Completion

April 5, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations

TU(1)