- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403478
Effects of Aquatic Exercise on Post-exercise Hypotension
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Paraíba
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Joao Pessoa, Paraíba, Brazil, 58051420
- Bruno Teixeira Barbosa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
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.
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Experimental: LICE
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.
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No specific exercise will be performed.
The participant will walk into the pool accompanied with a researcher for 45 minutes.
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Experimental: MICE
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.
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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. |
Experimental: HIIE
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.
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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. |
Experimental: Aquatic exercise training
The participants will be submitted to a 12-weeks of aquatic exercise program, twice a week, for 1 hour each day.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Entire day (an average of 24 hours).
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The blood pressure will be measured by a Ambulatory Blood Pressure Monitoring (ABPM).
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Entire day (an average of 24 hours).
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Blood pressure
Time Frame: Up to 1 hour post-exercise session
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The blood pressure will be measured by an automatic blood pressure device (OMRON HEM-720).
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Up to 1 hour post-exercise session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported sleep quality
Time Frame: Approximately 15 minutes
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Pittsburgh Sleep Quality Index
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Approximately 15 minutes
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Depressive symptoms (Mental disorders)
Time Frame: Approximately 5 minutes
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Geriatric depressive symptoms (GDS-15) is a validated questionnaire which will be used in order to evaluate depressive symptoms in elderly.
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Approximately 5 minutes
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Self-reported quality of life
Time Frame: Approximately 15 minutes
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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.
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Approximately 15 minutes
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Level of physical activity (BAECKE modified to elderly)
Time Frame: Approximately 5 minutes
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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.
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Approximately 5 minutes
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Functional Capacity
Time Frame: Approximately 35 minutes
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AAPHERD test battery
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Approximately 35 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruno T Barbosa, Master, University Center of Joao Pessoa - UNIPE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 79609117.0.0000.5188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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