HypertensionNCT03403478
Effects of Aquatic Exercise on Post-exercise Hypotension
A study testing LICE, MICE and HIIE in people with Hypertension and Aging, run by Federal University of Paraíba at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Aging, Obesity
- What is being tested?
- LICE, MICE and HIIE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly (60 years and over)
- Able to practice physical exercise in water
- Able to answer all questionnaires
- Non-smoker
Who cannot join
- Morbid obese
- Those who not complete all data collection procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypertension, Aging, Obesity
- Being tested
- LICE, MICE, HIIE, Aquatic exercise training
- Keywords
- Hemodynamics, Aquatic exercise, Elderly
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LICEOther
No specific exercise will be performed. The participant will walk into the pool accompanied with a researcher for 45 minutes.
MICEOther
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.
HIIEOther
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.
Aquatic exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| LICE | Experimental | 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. Receives: Other: LICE |
| MICE | Experimental | 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. Receives: Other: MICE |
| HIIE | Experimental | 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. Receives: Other: HIIE |
| Aquatic exercise training | Experimental | The participants will be submitted to a 12-weeks of aquatic exercise program, twice a week, for 1 hour each day. Receives: Other: Aquatic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
The blood pressure will be measured by a Ambulatory Blood Pressure Monitoring (ABPM).
Measured: Entire day (an average of 24 hours).
Blood pressure
The blood pressure will be measured by an automatic blood pressure device (OMRON HEM-720).
Measured: Up to 1 hour post-exercise session
Secondary outcomes (5)
Self-reported sleep quality
Pittsburgh Sleep Quality Index
Measured: Approximately 15 minutes
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.
Measured: Approximately 5 minutes
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.
Measured: Approximately 15 minutes
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.
Measured: Approximately 5 minutes
Functional Capacity
AAPHERD test battery
Measured: Approximately 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Mar 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- University Center of Joao Pessoa - UNIPE
- Responsible party
- Principal investigator, Bruno Teixeira Barbosa, Federal University of Paraíba
- Investigators
- Bruno T Barbosa, Master, Principal investigator, University Center of Joao Pessoa - UNIPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403478
- Sponsor's protocol ID
- 79609117.0.0000.5188
- Status last verified
- Jul 2019
- First submitted
- 7 Jan 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic Exercise on Post-exercise Hypotension
- ClinicalTrials.gov ID
- NCT03403478
- Acronym / sponsor ID
- 79609117.0.0000.5188
- Conditions
- Hypertension, Aging, Obesity
- Keywords
- Hemodynamics, Aquatic exercise, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- University Center of Joao Pessoa - UNIPE
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| LICE | Experimental | Other: LICEThe 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. |
| MICE | Experimental | Other: MICEThe 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. |
| HIIE | Experimental | Other: HIIEThe 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. |
| Aquatic exercise training | Experimental | Other: Aquatic exercise trainingThe participants will be submitted to a 12-weeks of aquatic exercise program, twice a week, for 1 hour each day. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elderly (60 years and over)
- Able to practice physical exercise in water
- Able to answer all questionnaires
- Non-smoker
Key exclusion criteria (2 listed)
- Morbid obese
- Those who not complete all data collection procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LICENo specific exercise will be performed. The participant will walk into the pool accompanied with a researcher for 45 minutes. | Other | LICE |
| MICEThe 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. | Other | MICE |
| HIIEThe 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. | Other | HIIE |
| Aquatic exercise trainingThe 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. | Other | Aquatic exercise training |
Primary outcome
Blood pressure
Time frame: Entire day (an average of 24 hours).
The blood pressure will be measured by a Ambulatory Blood Pressure Monitoring (ABPM).
Blood pressure
Time frame: Up to 1 hour post-exercise session
The blood pressure will be measured by an automatic blood pressure device (OMRON HEM-720).
5 secondary outcomes
Self-reported sleep quality
Time frame: Approximately 15 minutes
Depressive symptoms (Mental disorders)
Time frame: Approximately 5 minutes
Self-reported quality of life
Time frame: Approximately 15 minutes
Level of physical activity (BAECKE modified to elderly)
Time frame: Approximately 5 minutes
Functional Capacity
Time frame: Approximately 35 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno T Barbosa, Master principal investigator
University Center of Joao Pessoa - UNIPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LICE, MICE and HIIE in people with Hypertension and Aging, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Entire day (an average of 24 hours).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.