Healthy PeopleHIITxHMCNCT03293056
HIIH Versus HMC: Randomized Clinical Trial
A study testing High-intensity interval Hydrogynmastics and Hydrogynmastics Continuous Moderate in people with Healthy People, run by Universidade Federal do vale do São Francisco at 1 site in Brazil.
Trial summary
Introduction: water aerobics involves the practice of specific aquatic exercises that are based on the use of water resistance as a load and on thrust as an impact reducer, making it possible to perform physical exercise with a lower risk of injury even at a high intensity. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- High-intensity interval Hydrogynmastics and Hydrogynmastics Continuous Moderate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 31 Dec 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 60 years;
- sedentary and who did not perform physiotherapy and physical activity in the last three months;
- clinical and cognitive conditions for swimming pool activities and aerobic exercise; who have not undergone highly complex surgical procedures in the last six months;
- to be able of walking without help equipment and without musculoskeletal or skeletal diseases;
- without contraindications to the practice of exercises; such as: urinary and / or fecal incontinence and dermatological diseases;
- below obesity II with BMI <40.
Who cannot join
- if they have up to three consecutive fouls during the hydrogymnastics period;
- if they present any adverse effects, such as: allergy or any dermatitis;
- unable to continue the study due to change of address or hospitalization.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Physical Education College
Petrolina, Pernambuco, 56304917
Rodrigo GS Carvalho, PhD, 8721016856, rodrigo.carvalho@univasf.edu.br
About this study
Official title: Effectiveness of High-intensity Interval Versus Intensity Continuous Hydrogymnastics for Improvement of Health Outcomes: Randomized Clinical Trial.
Introduction: water aerobics involves the practice of specific aquatic exercises that are based on the use of water resistance as a load and on thrust as an impact reducer, making it possible to perform physical exercise with a lower risk of injury even at a high intensity. Objective: The overall objective of this study will be to compare the effectiveness of high intensity interval versus moderate continuous water aerobics to improve health outcomes in apparently healthy individuals.
Read the detailed description
Method: randomized clinical trial will be performed in the premises of the College of Physical Education of the Federal University of the São Francisco Valley. 100 adults, of both sexes, will be randomized into two groups, high intensity interval hydrogynastic (HIAI) or moderate continuous aquatic gymnastics (HCM). Individuals will be evaluated for primary endpoints of muscle strength and endurance, aerobic fitness, flexibility and body composition. The secondary outcomes evaluated will be the quality of life, functionality and perception of improvement by a Likert-type Improvement Scale, at the following moments: initial, final and follow-up of one month after the end of the training. Individuals will be assisted for three months, often weekly twice, with sessions lasting 50 min. In order to identify differences between and within the groups, an equation of generalized estimates will be used as regression model with the syntax according to the multivariate model.
- Conditions
- Healthy People
- Being tested
- High-intensity interval Hydrogynmastics, Hydrogynmastics Continuous Moderate
- Keywords
- aerobic exercises, training, aquatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval HydrogynmasticsOther
Also called HIIH
The HIIH to PSE group during the high intensity (HI) period should remain between 16 to 18 points, while in the moderate intensity (MI) intervals around 11. The dynamic exercises will progression, in the first month will be 1 min of HI and 2 min of MI, in the second month of 1 min of HI and 1 min of MI and in the last month of 1 min of HI and 30 s of MI, until completing 30 min in total.
Hydrogynmastics Continuous ModerateOther
Also called HCM
For the HCM group the PSE will be around 11 points during the 30 min of moderate continuous exercise. In both groups the form of intensity monitoring that will be through the PSE, in which this scale will be printed in banner form and affixed next to the physical education teacher during the classes.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity Interval Hydrogynmastics | Experimental | High-intensity Interval training Hydrogynmastics, 2x/week, for 3 months. Receives: Other: High-intensity interval Hydrogynmastics |
| Hydrogynmastics Continuous Moderate | Active comparator | Hydrogynmastics Continuous Moderate training (HCM), 2x/week, for 3 months. Receives: Other: Hydrogynmastics Continuous Moderate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Fitness
This maximal/submaximal test will be performed on cyclergometer, Balke test.
Measured: three months after randomization
Body Composition
The body composition (density and percentage of body fat) will be estimated by prediction equations (JACKSON et al., 1980).
Measured: three months after randomization
Strength Muscular
Strength Muscular will be measured by 1RM test in two exercises, involving the segments of the upper limbs (supine) and lower limbs (leg press).
Measured: three months after randomization
Endurance Muscular
Muscle endurance will be assessed by the test in which the individual performs the maximum number of repetitions of given exercises for one minute. The exercises will be of arm and abdominal flexion.
Measured: three months after randomization
Secondary outcomes (3)
Quality Life
Quality of life by assessed by WHOQOL-breaf
Measured: three months after randomization
Functionality
Functionality will be assessed by IVCF-20
Measured: three months after randomization
Perception of Improvement
Perception of Improvement will be measured by an Likert-type Improvement Scale
Measured: three months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies 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
- Parallel groups
- Model description
- Parallel Assignment: highintensity interval training water versus aerobic continuous
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do vale do São Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Rodrigo Gustavo da Silva Carvalho, Universidade Federal do vale do São Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293056
- Sponsor's protocol ID
- 012017
- Acronym
- HIITxHMC
- Status last verified
- May 2023
- First submitted
- 21 Sep 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-intensity Interval Versus Intensity Continuous Hydrogymnastics for Improvement of Health Outcomes: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03293056
- Acronym / sponsor ID
- HIITxHMC / 012017
- Conditions
- Healthy People
- Keywords
- aerobic exercises, training, aquatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universidade Federal do vale do São FranciscoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2017 (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.
Introduction: water aerobics involves the practice of specific aquatic exercises that are based on the use of water resistance as a load and on thrust as an impact reducer, making it possible to perform physical exercise with a lower risk of injury even at a high intensity. Objective: The overall objective of this study will be to compare the effectiveness of high intensity interval versus moderate continuous water aerobics to improve health outcomes in apparently healthy individuals.
Detailed description
Method: randomized clinical trial will be performed in the premises of the College of Physical Education of the Federal University of the São Francisco Valley. 100 adults, of both sexes, will be randomized into two groups, high intensity interval hydrogynastic (HIAI) or moderate continuous aquatic gymnastics (HCM). Individuals will be evaluated for primary endpoints of muscle strength and endurance, aerobic fitness, flexibility and body composition. The secondary outcomes evaluated will be the quality of life, functionality and perception of improvement by a Likert-type Improvement Scale, at the following moments: initial, final and follow-up of one month after the end of the training. Individuals will be assisted for three months, often weekly twice, with sessions lasting 50 min. In order to identify differences between and within the groups, an equation of generalized estimates will be used as regression model with the syntax according to the multivariate model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment: highintensity interval training water versus aerobic continuous
| Arm | Type | Receives |
|---|---|---|
| High-intensity Interval Hydrogynmastics | Experimental | Other: High-intensity interval HydrogynmasticsHigh-intensity Interval training Hydrogynmastics, 2x/week, for 3 months. |
| Hydrogynmastics Continuous Moderate | Active comparator | Other: Hydrogynmastics Continuous ModerateHydrogynmastics Continuous Moderate training (HCM), 2x/week, for 3 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age between 18 and 60 years;
- sedentary and who did not perform physiotherapy and physical activity in the last three months;
- clinical and cognitive conditions for swimming pool activities and aerobic exercise; who have not undergone highly complex surgical procedures in the last six months;
- to be able of walking without help equipment and without musculoskeletal or skeletal diseases;
- without contraindications to the practice of exercises; such as: urinary and / or fecal incontinence and dermatological diseases;
Key exclusion criteria (3 listed)
- if they have up to three consecutive fouls during the hydrogymnastics period;
- if they present any adverse effects, such as: allergy or any dermatitis;
- unable to continue the study due to change of address or hospitalization.
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 |
|---|---|---|
| High-intensity interval HydrogynmasticsAlso: HIIHThe HIIH to PSE group during the high intensity (HI) period should remain between 16 to 18 points, while in the moderate intensity (MI) intervals around 11. The dynamic exercises will progression, in the first month will be 1 min of HI and 2 min of MI, in the second month of 1 min of HI and 1 min of MI and in the last month of 1 min of HI and 30 s of MI, until completing 30 min in total. | Other | High-intensity Interval Hydrogynmastics |
| Hydrogynmastics Continuous ModerateAlso: HCMFor the HCM group the PSE will be around 11 points during the 30 min of moderate continuous exercise. In both groups the form of intensity monitoring that will be through the PSE, in which this scale will be printed in banner form and affixed next to the physical education teacher during the classes. | Other | Hydrogynmastics Continuous Moderate |
Primary outcome
Aerobic Fitness
Time frame: three months after randomization
This maximal/submaximal test will be performed on cyclergometer, Balke test.
Body Composition
Time frame: three months after randomization
The body composition (density and percentage of body fat) will be estimated by prediction equations (JACKSON et al., 1980).
Strength Muscular
Time frame: three months after randomization
Strength Muscular will be measured by 1RM test in two exercises, involving the segments of the upper limbs (supine) and lower limbs (leg press).
Endurance Muscular
Time frame: three months after randomization
Muscle endurance will be assessed by the test in which the individual performs the maximum number of repetitions of given exercises for one minute. The exercises will be of arm and abdominal flexion.
3 secondary outcomes
Quality Life
Time frame: three months after randomization
Functionality
Time frame: three months after randomization
Perception of Improvement
Time frame: three months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval Hydrogynmastics and Hydrogynmastics Continuous Moderate in people with Healthy People, run by Universidade Federal do vale do São Francisco 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo GS Carvalho, PhD (8721016856, rodrigo.carvalho@univasf.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Fitness (time frame: three months after randomization). The study lists 4 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 11 May 2023.