HealthyNCT06529354
24-Week Water Aerobics Program for Adults and Older Adults at Different Intensity Levels
A study testing Moderate-intensity Group and High-intensity Group in people with Healthy, run by University of Beira Interior at 1 site in Portugal.
Trial summary
This goal of this clinical trial is to verify the best way to do water aerobics with adults and older adults. It wants to answer these questions: Is high-intensity water aerobics better than water aerobics performed at moderate intensity? Does a 24-week water aerobics program improve muscle strength, body weight, fat… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Moderate-intensity Group and High-intensity Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Jan 2023to 28 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
Who cannot join
- taking part in another physical exercise program
- being recently hospitalized
- having severe motor or cognitive problems
- having any medical restrictions on physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Exercise Intensity in Water Aerobics: Improving Health Markers in Adults and Older Adults Over 24 Weeks
This goal of this clinical trial is to verify the best way to do water aerobics with adults and older adults. It wants to answer these questions:
- Is high-intensity water aerobics better than water aerobics performed at moderate intensity?
- Does a 24-week water aerobics program improve muscle strength, body weight, fat mass, triglycerides, cholesterol, blood pressure, and quality of life for adults and older adults?
Read more
Participants must:
- Do water aerobics at high or moderate intensity, twice a week for 45 minutes per class, for 24 weeks.
- Be assessed before starting the water aerobics program and after it ends to see if there are gains in muscle strength, body weight, fat mass, triglycerides, cholesterol, blood pressure, and quality of life.
It was believed that all variables would get better after doing water aerobics, no matter the intensity. It was also expected that doing higher-intensity water aerobics would lead to larger gains in all measurements compared to moderate-intensity.
- Conditions
- Healthy
- Being tested
- Moderate-intensity Group, High-intensity Group
- Keywords
- Aquatic exercise, Intensity, Physical fitness, Health-related, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity GroupBehavioural
In water aerobics sessions, the exercises are performed at a moderate intensity, between 60% and 70% of the participant's maximum heart rate predicted by their age.
High-intensity GroupBehavioural
In water aerobics sessions, the exercises are performed at a high intensity, between 80% and 90% of the participant's maximum heart rate predicted by their age.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity Group | Experimental | Participants engaged in 45-minute water aerobics sessions twice a week for 24 weeks at moderate intensities. Receives: Behavioral: Moderate-intensity Group |
| High-intensity Group | Experimental | Participants engaged in 45-minute water aerobics sessions twice a week for 24 weeks at high intensities. Receives: Behavioral: High-intensity Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in explosive strength of lower limbs at 24 weeks
The countermovement jump was used to assess the explosive strength of the lower limbs. Participants were instructed to perform three countermovement jumps, aiming to jump as high as possible, with one minute of rest between each jump. A higher jump height indicates a better score in this evaluation. The mean value of the three jumps was considered for the test.
Measured: Baseline and week 25
Change from Baseline in explosive strength of upper limbs at 24 weeks
The explosive strength of the upper limbs was measured by having participants throw a 3-kilogram medicine ball, with the best scores achieved by throwing the ball as far as possible. Three throws were performed, and the mean value was used in this test.
Measured: Baseline and week 25
Change from Baseline in endurance strength of lower limbs at 24 weeks
The chair stand test was used to evaluate the endurance strength of the lower limbs. Participants sat in the center of a chair with a straight back and feet shoulder-width apart and in full contact with the floor. They then rose to maximum extension and returned to the initial sitting position, aiming to complete as many repetitions as possible within a 30-second.
Measured: Baseline and week 25
Change from Baseline in endurance strength of upper limbs at 24 weeks
The arm curl test assessed the upper limbs' endurance strength. Participants were seated in a chair with a straight back and their feet flat on the floor, holding a 2 kg dumbbell in their dominant hand. They were instructed to perform as many correct flexions as possible within a 30-second time limit.
Measured: Baseline and week 25
Change from Baseline in body mass at 24 weeks
A bioimpedance balance was used for this test, with participants being barefoot and dressed in minimal clothing.
Measured: Baseline and week 25
Change from Baseline in fat mass percentage at 24 weeks
Measured: Baseline and week 25
Change from Baseline in fat-free mass at 24 weeks
Measured: Baseline and week 25
Change from Baseline in body mass index at 24 weeks
The body mass index (BMI) was calculated by dividing the body mass value by the height squared (kg/m^2). For this, each participant's height was measured using a precision stadiometer with a scale of 0.001 m. For the correct extraction of this test, participants were barefoot.
Measured: Baseline and week 25
Change from Baseline in triglycerides at 24 weeks
Blood samples were collected before exercise (after a 15-minute rest period) and at least 2 hours after the last meal.
Measured: Baseline and week 25
Change from Baseline in total cholesterol at 24 weeks
Measured: Baseline and week 25
Change from Baseline in diastolic blood pressure at 24 weeks
The automatic blood pressure monitor was used to measure the participants' blood pressure after seated and rested for 20 minutes.
Measured: Baseline and week 25
Change from Baseline in systolic blood pressure at 24 weeks
Measured: Baseline and week 25
Change from Baseline in resting heart rate at 24 weeks
Resting heart rate was assessed using an automatic blood pressure monitor, after the participant was seated and resting for at least 20 minutes.
Measured: Baseline and week 25
Secondary outcomes (1)
Change from Baseline in quality of life at 24 weeks
The WHOQOL-BREF (Portuguese version) questionnaire, consisting of 26 items, was used to evaluate the participants' quality of life. Of the 26 items, 2 pertain to general quality of life and general health, while the remaining 24 items assess the perception of quality of life in 4 domains: physical, psychological, social relationships, and environment. Higher scores indicate a higher quality of life in each domain.
Measured: Baseline and week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start30 Jan 2023
- Primary completion21 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís Oliveira Brandão Faíl, University of Beira Interior
- Investigators
- Luís Faíl, Principal investigator, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529354
- Sponsor's protocol ID
- CE-UBI-Pj-2019-051
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exercise Intensity in Water Aerobics: Improving Health Markers in Adults and Older Adults Over 24 Weeks
- ClinicalTrials.gov ID
- NCT06529354
- Acronym / sponsor ID
- CE-UBI-Pj-2019-051
- Conditions
- Healthy
- Keywords
- Aquatic exercise, Intensity, Physical fitness, Health-related, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 31 Jul 2024 (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 goal of this clinical trial is to verify the best way to do water aerobics with adults and older adults. It wants to answer these questions:
- Is high-intensity water aerobics better than water aerobics performed at moderate intensity?
- Does a 24-week water aerobics program improve muscle strength, body weight, fat mass, triglycerides, cholesterol, blood pressure, and quality of life for adults and older adults?
Participants must:
- Do water aerobics at high or moderate intensity, twice a week for 45 minutes per class, for 24 weeks.
- Be assessed before starting the water aerobics program and after it ends to see if there are gains in muscle strength, body weight, fat mass, triglycerides, cholesterol, blood pressure, and quality of life.
It was believed that all variables would get better after doing water aerobics, no matter the intensity. It was also expected that doing higher-intensity water aerobics would lead to larger gains in all measurements compared to moderate-intensity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity Group | Experimental | Behavioral: Moderate-intensity GroupParticipants engaged in 45-minute water aerobics sessions twice a week for 24 weeks at moderate intensities. |
| High-intensity Group | Experimental | Behavioral: High-intensity GroupParticipants engaged in 45-minute water aerobics sessions twice a week for 24 weeks at high intensities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years of age
Key exclusion criteria (4 listed)
- taking part in another physical exercise program
- being recently hospitalized
- having severe motor or cognitive problems
- having any medical restrictions on physical exercise
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 |
|---|---|---|
| Moderate-intensity GroupIn water aerobics sessions, the exercises are performed at a moderate intensity, between 60% and 70% of the participant's maximum heart rate predicted by their age. | Behavioural | Moderate-intensity Group |
| High-intensity GroupIn water aerobics sessions, the exercises are performed at a high intensity, between 80% and 90% of the participant's maximum heart rate predicted by their age. | Behavioural | High-intensity Group |
Primary outcome
Change from Baseline in explosive strength of lower limbs at 24 weeks
Time frame: Baseline and week 25
The countermovement jump was used to assess the explosive strength of the lower limbs. Participants were instructed to perform three countermovement jumps, aiming to jump as high as possible, with one minute of rest between each jump. A higher jump height indicates a better score in this evaluation. The mean value of the three jumps was considered for the test.
Change from Baseline in explosive strength of upper limbs at 24 weeks
Time frame: Baseline and week 25
The explosive strength of the upper limbs was measured by having participants throw a 3-kilogram medicine ball, with the best scores achieved by throwing the ball as far as possible. Three throws were performed, and the mean value was used in this test.
Change from Baseline in endurance strength of lower limbs at 24 weeks
Time frame: Baseline and week 25
The chair stand test was used to evaluate the endurance strength of the lower limbs. Participants sat in the center of a chair with a straight back and feet shoulder-width apart and in full contact with the floor. They then rose to maximum extension and returned to the initial sitting position, aiming to complete as many repetitions as possible within a 30-second.
Change from Baseline in endurance strength of upper limbs at 24 weeks
Time frame: Baseline and week 25
The arm curl test assessed the upper limbs' endurance strength. Participants were seated in a chair with a straight back and their feet flat on the floor, holding a 2 kg dumbbell in their dominant hand. They were instructed to perform as many correct flexions as possible within a 30-second time limit.
Change from Baseline in body mass at 24 weeks
Time frame: Baseline and week 25
A bioimpedance balance was used for this test, with participants being barefoot and dressed in minimal clothing.
Change from Baseline in fat mass percentage at 24 weeks
Time frame: Baseline and week 25
Change from Baseline in fat-free mass at 24 weeks
Time frame: Baseline and week 25
Change from Baseline in body mass index at 24 weeks
Time frame: Baseline and week 25
The body mass index (BMI) was calculated by dividing the body mass value by the height squared (kg/m^2). For this, each participant's height was measured using a precision stadiometer with a scale of 0.001 m. For the correct extraction of this test, participants were barefoot.
Change from Baseline in triglycerides at 24 weeks
Time frame: Baseline and week 25
Blood samples were collected before exercise (after a 15-minute rest period) and at least 2 hours after the last meal.
Change from Baseline in total cholesterol at 24 weeks
Time frame: Baseline and week 25
Change from Baseline in diastolic blood pressure at 24 weeks
Time frame: Baseline and week 25
The automatic blood pressure monitor was used to measure the participants' blood pressure after seated and rested for 20 minutes.
Change from Baseline in systolic blood pressure at 24 weeks
Time frame: Baseline and week 25
Change from Baseline in resting heart rate at 24 weeks
Time frame: Baseline and week 25
Resting heart rate was assessed using an automatic blood pressure monitor, after the participant was seated and resting for at least 20 minutes.
1 secondary outcome
Change from Baseline in quality of life at 24 weeks
Time frame: Baseline and week 25
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 31 Jul 2024.
- 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.
Luís Faíl principal investigator
University of Beira Interior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity Group and High-intensity Group in people with Healthy, run by University of Beira Interior at 1 site in Portugal.
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 1 inclusion and 4 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 31 Jul 2024. 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 Portugal. 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?
Change from Baseline in explosive strength of lower limbs at 24 weeks (time frame: Baseline and week 25). The study lists 13 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 31 Jul 2024.