Clinical trial NCT06243224: The Effect Of High Intensity Interval Training And Moderate Intensity Continuous Training In Patients With Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Life Style
Keywords: Aerobic training
Hypertension
Aerobic capasity
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 38
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Aerobic capasity
timeFrame: baseline and at 4rd weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Nurdan Metin, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Nilüfer Kutay Ordu Gökkaya, M.D
role: STUDY_DIRECTOR
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Ebru Alemdaroğlu, M.D
role: STUDY_CHAIR
affiliation: Ankara City Hospital Bilkent
name: Emre Aruğaslan, M.D
role: STUDY_CHAIR
References:
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 hypertension: EXERDIET-HTA study. Eur J Prev Cardiol. 2018 Mar;25(4):343-353. doi: 10.1177/2047487317749956. Epub 2018 Jan 9.
citation: 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.
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, 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.