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Effects of Aquatic Exercise on Post-exercise Hypotension

Primary Purpose

Hypertension, Aging, Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
LICE
MICE
HIIE
Aquatic exercise training
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hemodynamics, Aquatic exercise, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Elderly (60 years and over)
  • Able to practice physical exercise in water
  • Able to answer all questionnaires
  • Non-smoker

Exclusion Criteria:

  • Morbid obese
  • Those who not complete all data collection procedures

Sites / Locations

  • Bruno Teixeira Barbosa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Control group

LICE

MICE

HIIE

Aquatic exercise training

Arm Description

The volunteers will be instructed to remain in an orthostatic position immersed in water up to the imaginary line of the xiphoid process for 45 minutes without performing jerky body movements.

The light-intensity continuou exercise (LICE) session comprises a 45-minute of guide walking into the pool at 55-60% of maximum heart rate (HRmax). The HR will be checked every 2 minutes during the whole session.

The moderate-intensity continuous exercise (MICE) will bem performed divided into 3 phases: warm-up (10 minutes), main part (30 minutes) and cool down (5 minutes). The warm-up and cool down will be performed at 55-60% HRmax. The main part will last 30 minutes and will be performed by 3 sets of 5 exercises lasting 2 minutes each one at 70-75% HRmax. For all phases, HR will be measured every 2 minutes during the whole session.

The high-intensity intervaled exercise (HIIE) will bem performed divided into 3 phases: warm-up (10 minutes), main part (15 minutes) and cool down (5 minutes). The warm-up and cool down will be performed at 55-60% HRmax. The main part will last 15 minutes and will be performed by 2 sets of 5 exercises lasting 30 seconds to each exercise combined with 1 minute of active recovery. The exercise moment will be performed at 80-85% HRmax and the 1-minute active recovery at 55-60% HRmax. For both warm-up and cool down, HR will be measured every 2 minutes. For main part, HR will be measured at the end of each 30-seconds from exercise.

The participants will be submitted to a 12-weeks of aquatic exercise program, twice a week, for 1 hour each day.

Outcomes

Primary Outcome Measures

Blood pressure
The blood pressure will be measured by a Ambulatory Blood Pressure Monitoring (ABPM).
Blood pressure
The blood pressure will be measured by an automatic blood pressure device (OMRON HEM-720).

Secondary Outcome Measures

Self-reported sleep quality
Pittsburgh Sleep Quality Index
Depressive symptoms (Mental disorders)
Geriatric depressive symptoms (GDS-15) is a validated questionnaire which will be used in order to evaluate depressive symptoms in elderly.
Self-reported quality of life
Quality of life will be assessed by the WHOQOL-OLD questionnaire and it consists of 24 items on the likert scale attributed to 6 facets: 1) Sensory functioning, 2) Autonomy, 3) Past, present and future activities, 4) Social participation, 5) Death and dying, and 6) Intimacy. Each facet is composed of 4 items, so for each facet the score can range from 4 to 20. For this evaluation, the higher the score, the higher the quality of life.
Level of physical activity (BAECKE modified to elderly)
The Habitual Physical Activity Questionnaire originated in 1982 by Baecke and colleagues (BAECKE; BUREMA, FRIJTERS, 1982) and was adapted for the elderly and validated later (VORORRIPS et al., 1991) and recently translated into Portuguese (SIMÕES, 2009). It is applied in the form of an interview, and has as reference the last 12 months being divided into 3 sections (1 - Domestic physical activities, 2 - Sporting activities and 3 - Activities in free time). From the scores attributed to each response provided by the elderly, scores equivalent to each section cited above are established. It is suggested that 3 cutoff points be created for the classification of the elderly regarding the level of physical activity (low, moderate and high) based on terciles.
Functional Capacity
AAPHERD test battery

Full Information

First Posted
January 7, 2018
Last Updated
July 1, 2019
Sponsor
Federal University of Paraíba
Collaborators
University Center of Joao Pessoa - UNIPE
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1. Study Identification

Unique Protocol Identification Number
NCT03403478
Brief Title
Effects of Aquatic Exercise on Post-exercise Hypotension
Official Title
Effects of Aquatic Exercise on Post-exercise Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
Collaborators
University Center of Joao Pessoa - UNIPE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized controlled trial. The present study involves an acute and chronic intervention, which is a water-based exercise (one session: to acute intervention; 12-weeks of aquatic exercise program: to chronic intervention). The sample will be composed by elderly enrolled in university extension program titled "Hidroginastica na Terceira Idade" (Hydrogymnastics in aging). It will be evaluated the effects of water-based exercise on hemodynamics, self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity. The investigators hypothesized that an acute water-based exercise under different intensities promotes hemodynamics changes in elderly. In addition, the investigators hypothesized that 12-weeks of aquatic exercise may lead improvements in self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity in elderly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Aging, Obesity
Keywords
Hemodynamics, Aquatic exercise, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
To acute session, the participant will not be informed about what aquatic exercise session (light-, moderate-, high-intensity or control) intensity will be performed.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The volunteers will be instructed to remain in an orthostatic position immersed in water up to the imaginary line of the xiphoid process for 45 minutes without performing jerky body movements.
Arm Title
LICE
Arm Type
Experimental
Arm Description
The light-intensity continuou exercise (LICE) session comprises a 45-minute of guide walking into the pool at 55-60% of maximum heart rate (HRmax). The HR will be checked every 2 minutes during the whole session.
Arm Title
MICE
Arm Type
Experimental
Arm Description
The moderate-intensity continuous exercise (MICE) will bem performed divided into 3 phases: warm-up (10 minutes), main part (30 minutes) and cool down (5 minutes). The warm-up and cool down will be performed at 55-60% HRmax. The main part will last 30 minutes and will be performed by 3 sets of 5 exercises lasting 2 minutes each one at 70-75% HRmax. For all phases, HR will be measured every 2 minutes during the whole session.
Arm Title
HIIE
Arm Type
Experimental
Arm Description
The high-intensity intervaled exercise (HIIE) will bem performed divided into 3 phases: warm-up (10 minutes), main part (15 minutes) and cool down (5 minutes). The warm-up and cool down will be performed at 55-60% HRmax. The main part will last 15 minutes and will be performed by 2 sets of 5 exercises lasting 30 seconds to each exercise combined with 1 minute of active recovery. The exercise moment will be performed at 80-85% HRmax and the 1-minute active recovery at 55-60% HRmax. For both warm-up and cool down, HR will be measured every 2 minutes. For main part, HR will be measured at the end of each 30-seconds from exercise.
Arm Title
Aquatic exercise training
Arm Type
Experimental
Arm Description
The participants will be submitted to a 12-weeks of aquatic exercise program, twice a week, for 1 hour each day.
Intervention Type
Other
Intervention Name(s)
LICE
Intervention Description
No specific exercise will be performed. The participant will walk into the pool accompanied with a researcher for 45 minutes.
Intervention Type
Other
Intervention Name(s)
MICE
Intervention Description
The following exercises will be carried out: a) jumping jacks (shoulder abduction and adduction); b) horizontal adduction and abduction of the shoulder; c) stationary running with knee elevation; d) pull and push horizontally with upper limbs; e) pull and push vertically with upper limbs. Note: For exercises 'a' and 'b', the legs alternated in movements in the sagittal plane to provide greater stability to the participant's movement. For exercises 'd' and 'e', the legs simulates a stationary running.
Intervention Type
Other
Intervention Name(s)
HIIE
Intervention Description
The following exercises will be carried out: a) jumping jacks (shoulder abduction and adduction); b) horizontal adduction and abduction of the shoulder; c) stationary running with knee elevation; d) pull and push horizontally with upper limbs; e) pull and push vertically with upper limbs. Note: For exercises 'a' and 'b', the legs alternated in movements in the sagittal plane to provide greater stability to the participant's movement. For exercises 'd' and 'e', the legs simulates a stationary running.
Intervention Type
Other
Intervention Name(s)
Aquatic exercise training
Intervention Description
The sessions of the aquatic exercise training will be divided into 3 phases: warm-up (10 minutes), main part (40 minutes) and cool down. In order to increase intensity to aquatic exercise, the training program will carried out as follows: From week 1 to 4 the instructors will use a 128 bpm musics in both warm-up and cool down. In main part, will be used a 130 bmp musics. From week 5 to 8 the instructors will use a 130 bpm musics in both warm-up and cool down. In main part, will be used a 132 bmp musics. From week 9 to 12 the instructors will use a 132 bpm musics in both warm-up and cool down. In main part, will be used a 135 bmp musics.
Primary Outcome Measure Information:
Title
Blood pressure
Description
The blood pressure will be measured by a Ambulatory Blood Pressure Monitoring (ABPM).
Time Frame
Entire day (an average of 24 hours).
Title
Blood pressure
Description
The blood pressure will be measured by an automatic blood pressure device (OMRON HEM-720).
Time Frame
Up to 1 hour post-exercise session
Secondary Outcome Measure Information:
Title
Self-reported sleep quality
Description
Pittsburgh Sleep Quality Index
Time Frame
Approximately 15 minutes
Title
Depressive symptoms (Mental disorders)
Description
Geriatric depressive symptoms (GDS-15) is a validated questionnaire which will be used in order to evaluate depressive symptoms in elderly.
Time Frame
Approximately 5 minutes
Title
Self-reported quality of life
Description
Quality of life will be assessed by the WHOQOL-OLD questionnaire and it consists of 24 items on the likert scale attributed to 6 facets: 1) Sensory functioning, 2) Autonomy, 3) Past, present and future activities, 4) Social participation, 5) Death and dying, and 6) Intimacy. Each facet is composed of 4 items, so for each facet the score can range from 4 to 20. For this evaluation, the higher the score, the higher the quality of life.
Time Frame
Approximately 15 minutes
Title
Level of physical activity (BAECKE modified to elderly)
Description
The Habitual Physical Activity Questionnaire originated in 1982 by Baecke and colleagues (BAECKE; BUREMA, FRIJTERS, 1982) and was adapted for the elderly and validated later (VORORRIPS et al., 1991) and recently translated into Portuguese (SIMÕES, 2009). It is applied in the form of an interview, and has as reference the last 12 months being divided into 3 sections (1 - Domestic physical activities, 2 - Sporting activities and 3 - Activities in free time). From the scores attributed to each response provided by the elderly, scores equivalent to each section cited above are established. It is suggested that 3 cutoff points be created for the classification of the elderly regarding the level of physical activity (low, moderate and high) based on terciles.
Time Frame
Approximately 5 minutes
Title
Functional Capacity
Description
AAPHERD test battery
Time Frame
Approximately 35 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elderly (60 years and over) Able to practice physical exercise in water Able to answer all questionnaires Non-smoker Exclusion Criteria: Morbid obese Those who not complete all data collection procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno T Barbosa, Master
Organizational Affiliation
University Center of Joao Pessoa - UNIPE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bruno Teixeira Barbosa
City
Joao Pessoa
State/Province
Paraíba
ZIP/Postal Code
58051420
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Aquatic Exercise on Post-exercise Hypotension

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