High-Intensity Interval Versus Moderate-Intensity Continuous Water Based Exercise in Hypertensive Older Individuals

Hypertension Clinical Trial

— HExOLD  

Official title:

Effects of High-Intensity Interval Versus Moderate-Intensity Continuous Heated Water-Based Exercise on Blood Pressure and Hemodynamic Variables in Older Individuals With Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04126785
• Other study ID #: ECDR 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: May 2021

Study information

• Verified date: October 2019
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Emmanuel Gomes G Ciolac, Phd
• Phone: +551431039623
• Email: emmanuel.ciolac[@]unesp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the acute and chronic effects in hemodynamic and autonomic variables to high-intensity interval versus moderate-intensity continuous heated water-based exercise in older individuals with hypertension.

Description:

BACKGROUND: Population aging is an unprecedented worldwide reality, which results in a change of epidemiological profile and increased prevalence of age-related non-communicable chronic diseases (NCDs). Among age-related NCDs, systemic arterial hypertension (HPT) is the leading cause of mortality and disability worldwide and has increased prevalence, morbidity and mortality with advancing age. Increase in physical activity level through regular physical exercise is one of the main global goals for the prevention and treatment of HPT and others NCDs. Among the different exercise types and intensities, high intensity interval exercise (HIIT) showed superior benefits for reducing blood pressure (BP) and improving variables involved in the pathophysiology of HPT when compared to continuous moderate-intensity exercise (MICE). However individuals with comorbidities or injures are not capable to follow adequate intensity of both types of exercise. Heated water-based has been used as an option to facilitate the individuals adherence to exercise and positive results especially in BP levels. Despite this, little is known about the effect of HIIT or MICE in heated water-based on BP and other hemodynamic variables involved in the pathophysiology of HPT in older hypertensive individuals. PURPOSE: To evaluate the hemodynamic and autonomic response to a HIIT versus MICE session and in 12 weeks of training in older individuals with hypertension. METHODS: 60 elderly hypertensives of both genders, aged over 60 years, will be randomized in the ratio 2: 2: 1 to 12 weeks of high intensity interval training (HIIT), moderate intensity continuous (MICE) or control follow-up without exercise (CON), respectively. Exercise programs will be discontinued after 12 weeks, and individuals will be followed up for another 12 weeks. Individuals will have their physical (cardiorespiratory and muscular) and functional capacity (walking, sitting and lifting ability), hemodynamic variables (blood pressure, arterial stiffness, endothelial function and cardiovascular response to exercise) and autonomic variables (variability of heart rate) and quality of life assessed before and after 12 and 24 weeks of follow-up. Before the beginning of the follow-up, 20 elderly hypertensive patients will also have a hemodynamic response (ambulatory blood pressure, endothelial function, arterial stiffness) and autonomic (heart rate variability) to a session of HI-HEx, MI-HEx and CON evaluated and compared. The feasibility of HIIE and MICE will also be assessed over the 12 weeks of its implementation. HIIT will consisted of warm up (4 min), 21 min of 1 min high intensity exercise (level 15) and "very hard" (level 17) of the subjective Rating of Perceived Exertion Scale (RPE) alternating with 2 min of walking at intensity between "easy" (level 9) and "fairly easy" (level 11) of the RPE. MICE will performed of 4 min warm up and 26 min of walking or jogging at intensity between "fairly light" (level 11) and " somewhat hard " (level 13) of the RPE.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• =60 years old;

• Hypertension diagnosed at least 6 months earlier (stage 1 or 2);

• Antihypertensive drug treatment and without dosage alteration at least 3 months earlier;

• Blood pressure inferior to 140/90 mmHg in medical office.

Non-inclusion criteria:

• Smoking individuals;

• Uncontrolled cardiovascular disease;

• Disability;

• Deficit cognitive;

Exclusion Criteria:

• Non 100% participation;

• Change (or stopped) clinical or drug treatment.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• High Intensity Interval Exercise in Heated Water-Based
High intensity interval exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level of rate perceived exertion (RPE) scale, followed by 21 min of HIIE, alternating 1 min of jogging/running at 15-17 (hard-very hard) level with 2 min of walking at 9-11 (very light-fairly light) level of RPE.
• Continuous Moderate Exercise in Heated Water-Based
Continuous moderate exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level (light) of RPE, followed by 26 min of MICE, walking at 11-13 (fairly light)level of RPE.
• Control Group
CON session will perform at controlled heated water-base (30 e 32 ºC). Subject will be seated in a chair and submerged at the until xiphoid process level for 30 min.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Fundação de Amparo à Pesquisa do Estado de São Paulo

References & Publications (9)

Castro RE, Guimarães GV, Da Silva JM, Bocchi EA, Ciolac EG. Postexercise Hypotension after Heart Transplant: Water- versus Land-Based Exercise. Med Sci Sports Exerc. 2016 May;48(5):804-10. doi: 10.1249/MSS.0000000000000846. — View Citation

Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimarães 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

Ciolac EG, Carvalho VO, Guimarães GV. High-intensity interval vs. moderate steady-state exercise. Am J Hypertens. 2010 Aug;23(8):812; author reply 813. doi: 10.1038/ajh.2010.108. — View Citation

Ciolac EG, Guimarães GV, D Avila VM, Bortolotto LA, Doria EL, Bocchi EA. Acute effects of continuous and interval aerobic exercise on 24-h ambulatory blood pressure in long-term treated hypertensive patients. Int J Cardiol. 2009 Apr 17;133(3):381-7. doi: — View Citation

Ciolac EG, Guimarães GV, D'Avila VM, Bortolotto LA, Doria EL, Bocchi EA. Acute aerobic exercise reduces 24-h ambulatory blood pressure levels in long-term-treated hypertensive patients. Clinics (Sao Paulo). 2008 Dec;63(6):753-8. — View Citation

Ciolac EG, Roberts CK, da Silva JM, Guimarães GV. Age affects exercise-induced improvements in heart rate response to exercise. Int J Sports Med. 2014 May;35(5):371-8. doi: 10.1055/s-0033-1351332. Epub 2013 Oct 15. — View Citation

Ciolac EG. High-intensity interval training and hypertension: maximizing the benefits of exercise? Am J Cardiovasc Dis. 2012;2(2):102-10. Epub 2012 May 15. — View Citation

Guimãraes GV, Fernandes-Silva MM, Drager LF, de Barros Cruz LG, Castro RE, Ciolac EG, Bocchi EA. Hypotensive Effect of Heated Water-Based Exercise Persists After 12-Week Cessation of Training in Patients With Resistant Hypertension. Can J Cardiol. 2018 De — View Citation

Ngomane AY, Fernandes B, Guimarães GV, Ciolac EG. Hypotensive Effect of Heated Water-based Exercise in Older Individuals with Hypertension. Int J Sports Med. 2019 Apr;40(4):283-291. doi: 10.1055/a-0828-8017. Epub 2019 Feb 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise.	Blood pressure will be assessed in resting (Omron HEM 7200®, Omron Healthcare Inc, Dalian, China) at the day of the sessions and using a 24 hour ambulatory blood pressure monitoring (Cardio-Mapa ®, Cardios System Ltda, Sao Paulo, Brazil), at the baseline and after 12 weeks of exercise.	12 weeks
Secondary	Effect of exercise in hemodynamic and autonomic variables assessed by endothelial function, arterial stiffness and heart rate variability	The arterial stiffness will be assessed by pulse wave velocity (Vicorder®, SMT Medical GmbH & Co., Wuerzburg, Germany) as well the endothelial function by Endocheck®. The heart rate variability will be measure using (Polar RS800CX®,Polar Electro Oy, Kempele, Finland) and 24 hour HOLTER monitoring (Cardio-Mapa ®, Cardios System Ltda, Sao Paulo, Brazil). All the measurements will be assessed at the pre and post moments of exercise protocol.	12 weeks
Secondary	Effect of exercise in functional capacity assessed by handgrip strength test.	The handgrip strength test will assessed using Jamar®. The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. The participant will squeeze the dynamometer with maximum isometric effort, which is maintained for about 5 seconds.The test will be performed in a single day (pre and post 12 weeks of exercise).	12 weeks
Secondary	Effect of exercise in functional capacity assessed by 5 times sit to stand test.	The 5 times sit to stand test will measure the time taken to perform 5 repetitions of rising from a standard chair without armrest (seat height of 46 cm) to a full upright position as quickly as possible and without assistance. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.	12 weeks
Secondary	Effect of exercise in functional capacity assessed by sit and reach test.	The sit and reach test (Wells®) will be used to assess the posterior thigh and lower back flexibility. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.	12 weeks
Secondary	Effect of exercise in functional capacity assessed by timed up and go test.	The timed up and go test will be measured measured by the time to get up from a chair without armrest (seat height of 46 cm) and without assistance, walk 3 m at normal speed, turn around, walk back and sit down. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.	12 weeks
Secondary	Effect of exercise in functional capacity assessed by 6 minutes walk test.	The 6 minutes walk test will measure the distance (30 meters) that the participant can quickly walk on a flat, hard surface in a period of 6 minutes. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.	12 weeks
Secondary	Quality of Life assessed by International Physical Activity Questionnaire	The International Physical Activity Questionnaire short version (validated in the Brazilian population) will be used to assess the daily physical activity level in all volunteers.	12 weeks