Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06243224
Other study ID # nurdan.mtn
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2023
Est. completion date April 5, 2024

Study information

Verified date May 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date April 5, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 35 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Ankara Bilkent City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View Citation

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 hypertensio — View Citation

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, — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A