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

Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho (Other)
Overall Status
Unknown status
CT.gov ID
NCT04126785
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
60
3
18

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: High Intensity Interval Exercise in Heated Water-Based
  • Other: Continuous Moderate Exercise in Heated Water-Based
  • Other: Control Group
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 trialThe 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 (Investigator, Outcomes Assessor)
Masking Description:
In study 1 and 2 the participants will be aleatory randomized and the main investigator will perform the exercise session. The data will collected and assessed by a blinded investigator without knowledge of participants intervention.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control without exercise in heated water-based

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
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.
Other Names:
  • CON
  • Experimental: High Intensity Interval Exercise in Heated Water

    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
    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 Names:
  • HIIT
  • Experimental: Continuous Moderate Exercise in Heated Water

    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
    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 Names:
  • MICE
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise. [12 weeks]

      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.

    Secondary Outcome Measures

    1. Effect of exercise in hemodynamic and autonomic variables assessed by endothelial function, arterial stiffness and heart rate variability [12 weeks]

      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.

    2. Effect of exercise in functional capacity assessed by handgrip strength test. [12 weeks]

      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).

    3. Effect of exercise in functional capacity assessed by 5 times sit to stand test. [12 weeks]

      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.

    4. Effect of exercise in functional capacity assessed by sit and reach test. [12 weeks]

      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.

    5. Effect of exercise in functional capacity assessed by timed up and go test. [12 weeks]

      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.

    6. Effect of exercise in functional capacity assessed by 6 minutes walk test. [12 weeks]

      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.

    7. Quality of Life assessed by International Physical Activity Questionnaire [12 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universidade Estadual Paulista Júlio de Mesquita Filho
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    • Principal Investigator: Emmanuel G Ciolac, Phd, Sao Paulo State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emmanuel Gomes Ciolac, Principal Investigator, Universidade Estadual Paulista Júlio de Mesquita Filho
    ClinicalTrials.gov Identifier:
    NCT04126785
    Other Study ID Numbers:
    • ECDR 1
    First Posted:
    Oct 15, 2019
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emmanuel Gomes Ciolac, Principal Investigator, Universidade Estadual Paulista Júlio de Mesquita Filho
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2019