HealthyNCT06509217
12 Weeks of Water Aerobics at Various Intensities for Adults and Older Adults
A study testing Moderate-intensity Group and High-intensity Group in people with Healthy, run by Luís Oliveira Brandão Faíl at 1 site in Portugal.
Trial summary
The objective of this clinical trial is to understand the best intensity to perform water aerobics with adults and older adults. The main questions it aims to answer are: Is water aerobics performed at high intensity better than water aerobics performed at moderate intensity? Is performing water aerobics for 12 weeks… 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
- 21 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Sep 2022to 23 Dec 2022
- 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: Effects of 12-week Moderate-intensity vs High-intensity Water-aerobic Training on Physical Fitness, Cardiovascular Health, and Well-being in Adults and Older Adults
The objective of this clinical trial is to understand the best intensity to perform water aerobics with adults and older adults. The main questions it aims to answer are:
- Is water aerobics performed at high intensity better than water aerobics performed at moderate intensity?
- Is performing water aerobics for 12 weeks good for muscle strength, body composition (body weight, fat mass), lipid profile (triglycerides, cholesterol), blood pressure, and quality of life in adults and older adults?
Read more
Participants need:
- Perform water aerobics at high or moderate intensity, twice a week, 45 minutes per class, for 12 weeks
- Be evaluated in the week before starting the water aerobics program (week 0) and at the end week of the program (week 12) regarding muscle strength, body composition, lipid profile, blood pressure, and quality of life
It was hypothesized that independently of the level of intensity used, all variables would improve after water aerobics. It was also expected to observe more gains in all parameters in high-intensity water aerobics 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
Water aerobics sessions involved exercises performed at a moderate intensity, between 60% and 70% of the participant's maximum heart rate predicted by their age.
High-intensity GroupBehavioural
Water aerobics sessions involved exercises 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 performed water aerobics at moderate intensities. Water aerobics classes lasted approximately 45 minutes and were held twice a week for 12 weeks Receives: Behavioral: Moderate-intensity Group |
| High-intensity Group | Experimental | Participants performed water aerobics at high intensities. Water aerobics classes lasted approximately 45 minutes and were held twice a week for 12 weeks 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 12 weeks
The explosive strength of the lower limbs was evaluated using the countermovement jump.Three jumps with countermovement were performed, with participants instructed to jump as high as possible, with one minute of rest between repetitions. A higher jump height corresponds to a better score. In this test, the mean value was considered.
Measured: Baseline and week 12
Change from Baseline in explosive strength of upper limbs at 12 weeks
The explosive strength of the upper limbs was evaluated using medicine ball throw. Each participant was encouraged to throw a 3-kilogram medicine ball, as far as possible. The best scores are achieved by throwing the ball as far as possible. In this test, the mean value was considered.
Measured: Baseline and week 12
Change from Baseline in endurance strength of lower limbs at 12 weeks
The endurance strength of the lower limbs was assessed using the chair stand test. The chair stand test entailed the participant sitting in the center of the chair with a straight back and feet shoulder-width apart and in full contact with the floor. The upper limbs were crossed at the wrist level and positioned against the chest. Upon receiving the starting signal, the participant rose to maximum extension and returned to the initial sitting position, striving to complete the maximum number of repetitions within a 30-second time frame.
Measured: Baseline and week 12
Change from Baseline in endurance strength of upper limbs at 12 weeks
The endurance strength of the upper limbs was assessed using the arm curl test. In this test, the participant was seated in a chair with the back straight and fully leaning against the chair, with their feet flat on the floor. A 2 kg dumbbell was held in their dominant hand, and the test commenced with the forearm in a lower position, near the chair, perpendicular to the floor. Upon receiving the start signal, the participant performed a complete flexion of the forearm and then returned to the initial position of forearm extension. The evaluator encouraged the participant to perform as many repetitions as possible within a time limit of 30 seconds, counting each correct flexion performed.
Measured: Baseline and week 12
Change from Baseline in body mass at 12 weeks
A bioimpedance balance was used. For the correct extraction of this test, participants were barefoot and dressed in as little clothing as possible.
Measured: Baseline and week 12
Change from Baseline in fat mass percentage at 12 weeks
Measured: Baseline and week 12
Change from Baseline in fat-free mass at 12 weeks
Measured: Baseline and week 12
Change from Baseline in body mass index at 12 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 12
Change from Baseline in triglycerides at 12 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 12
Change from Baseline in total cholesterol at 12 weeks
Measured: Baseline and week 12
Change from Baseline in diastolic blood pressure at 12 weeks
This measure was assessed using an automatic blood pressure monitor, after the participant was seated and resting for at least 20 minutes.
Measured: Baseline and week 12
Change from Baseline in systolic blood pressure at 12 weeks
Measured: Baseline and week 12
Change from Baseline in resting heart rate at 12 weeks
This measure was assessed using an automatic blood pressure monitor, after the participant was seated and resting for at least 20 minutes.
Measured: Baseline and week 12
Secondary outcomes (1)
Change from Baseline in quality of life at 12 weeks
The WHOQOL-BREF (Portuguese version) questionnaire with 26 items was used to assess the participants' quality of life. Of the 26 items, 2 are related to the general quality of life and general health, and the remaining 24 items assess the perception of quality of life in 4 domains: physical, psychological, social relationships, and environment. The higher the final score, the higher the participant's quality of life in each domain.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start19 Sep 2022
- Primary completion16 Dec 2022
- Study completion23 Dec 2022
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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luís Oliveira Brandão Faíl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT06509217
- Sponsor's protocol ID
- ID1475
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 19 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12-week Moderate-intensity vs High-intensity Water-aerobic Training on Physical Fitness, Cardiovascular Health, and Well-being in Adults and Older Adults
- ClinicalTrials.gov ID
- NCT06509217
- Acronym / sponsor ID
- ID1475
- Conditions
- Healthy
- Keywords
- Aquatic exercise, Intensity, Physical fitness, Health-related, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Luís Oliveira Brandão FaílUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 19 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.
The objective of this clinical trial is to understand the best intensity to perform water aerobics with adults and older adults. The main questions it aims to answer are:
- Is water aerobics performed at high intensity better than water aerobics performed at moderate intensity?
- Is performing water aerobics for 12 weeks good for muscle strength, body composition (body weight, fat mass), lipid profile (triglycerides, cholesterol), blood pressure, and quality of life in adults and older adults?
Participants need:
- Perform water aerobics at high or moderate intensity, twice a week, 45 minutes per class, for 12 weeks
- Be evaluated in the week before starting the water aerobics program (week 0) and at the end week of the program (week 12) regarding muscle strength, body composition, lipid profile, blood pressure, and quality of life
It was hypothesized that independently of the level of intensity used, all variables would improve after water aerobics. It was also expected to observe more gains in all parameters in high-intensity water aerobics 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 performed water aerobics at moderate intensities. Water aerobics classes lasted approximately 45 minutes and were held twice a week for 12 weeks |
| High-intensity Group | Experimental | Behavioral: High-intensity GroupParticipants performed water aerobics at high intensities. Water aerobics classes lasted approximately 45 minutes and were held twice a week for 12 weeks |
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 GroupWater aerobics sessions involved exercises 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 GroupWater aerobics sessions involved exercises 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 12 weeks
Time frame: Baseline and week 12
The explosive strength of the lower limbs was evaluated using the countermovement jump.Three jumps with countermovement were performed, with participants instructed to jump as high as possible, with one minute of rest between repetitions. A higher jump height corresponds to a better score. In this test, the mean value was considered.
Change from Baseline in explosive strength of upper limbs at 12 weeks
Time frame: Baseline and week 12
The explosive strength of the upper limbs was evaluated using medicine ball throw. Each participant was encouraged to throw a 3-kilogram medicine ball, as far as possible. The best scores are achieved by throwing the ball as far as possible. In this test, the mean value was considered.
Change from Baseline in endurance strength of lower limbs at 12 weeks
Time frame: Baseline and week 12
The endurance strength of the lower limbs was assessed using the chair stand test. The chair stand test entailed the participant sitting in the center of the chair with a straight back and feet shoulder-width apart and in full contact with the floor. The upper limbs were crossed at the wrist level and positioned against the chest. Upon receiving the starting signal, the participant rose to maximum extension and returned to the initial sitting position, striving to complete the maximum number of repetitions within a 30-second time frame.
Change from Baseline in endurance strength of upper limbs at 12 weeks
Time frame: Baseline and week 12
The endurance strength of the upper limbs was assessed using the arm curl test. In this test, the participant was seated in a chair with the back straight and fully leaning against the chair, with their feet flat on the floor. A 2 kg dumbbell was held in their dominant hand, and the test commenced with the forearm in a lower position, near the chair, perpendicular to the floor. Upon receiving the start signal, the participant performed a complete flexion of the forearm and then returned to the initial position of forearm extension. The evaluator encouraged the participant to perform as many repetitions as possible within a time limit of 30 seconds, counting each correct flexion performed.
Change from Baseline in body mass at 12 weeks
Time frame: Baseline and week 12
A bioimpedance balance was used. For the correct extraction of this test, participants were barefoot and dressed in as little clothing as possible.
Change from Baseline in fat mass percentage at 12 weeks
Time frame: Baseline and week 12
Change from Baseline in fat-free mass at 12 weeks
Time frame: Baseline and week 12
Change from Baseline in body mass index at 12 weeks
Time frame: Baseline and week 12
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 12 weeks
Time frame: Baseline and week 12
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 12 weeks
Time frame: Baseline and week 12
Change from Baseline in diastolic blood pressure at 12 weeks
Time frame: Baseline and week 12
This measure was assessed using an automatic blood pressure monitor, after the participant was seated and resting for at least 20 minutes.
Change from Baseline in systolic blood pressure at 12 weeks
Time frame: Baseline and week 12
Change from Baseline in resting heart rate at 12 weeks
Time frame: Baseline and week 12
This measure 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 12 weeks
Time frame: Baseline and week 12
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 19 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 Luís Oliveira Brandão Faíl 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 19 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 12 weeks (time frame: Baseline and week 12). 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 19 Jul 2024.