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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: High Intensity Interval Exercise in Heated Water-Based
* Other: Continuous Moderate Exercise in Heated Water-Based
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study 1 will be cross-over, randomized, controlled and single-blinded trial The study 2 will be randomized, parallel, controlled and single-blinded trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control without exercise in heated water-based<br>CON session will perform at controlled heated water-base (30 e 32 ºC). Subject will be seated in a chair and submerged at the xiphoid process level for 30 min. | Other: Control Group<br>* 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.<br>* Other names: CON;|
| Experimental: High Intensity Interval Exercise in Heated Water<br>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. | Other: High Intensity Interval Exercise in Heated Water-Based<br>* 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.<br>* Other names: HIIT;|
| Experimental: Continuous Moderate Exercise in Heated Water<br>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. | Other: Continuous Moderate Exercise in Heated Water-Based<br>* 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.<br>* Other names: MICE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Blood Pressure, Endothelial function, Exercise, Heart rate variability