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RecruitingNCT03293056HIITxHMCUpdated May 11, 2023

HIIH Versus HMC: Randomized Clinical Trial

An interventional study of High-intensity interval Hydrogynmastics and Hydrogynmastics Continuous Moderate in Healthy People, sponsored by Universidade Federal do vale do São Francisco. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Universidade Federal do vale do São Francisco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2019; still recruiting 7 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy People

Keywords

  • aerobic exercises
  • training
  • aquatic
03

In context

Lead sponsor

Universidade Federal do vale do São Francisco is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 to the practice of exercises; such as: urinary and / or fecal incontinence and dermatological diseases;
  • below obesity II with \<40.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    High-intensity Interval Hydrogynmastics

    High-intensity Interval training Hydrogynmastics, 2x/week, for 3 months.

    Other: High-intensity interval Hydrogynmastics

  • Active comparator
    Hydrogynmastics Continuous Moderate

    Hydrogynmastics Continuous Moderate training (HCM), 2x/week, for 3 months.

    Other: Hydrogynmastics Continuous Moderate

Interventions

  • OtherHigh-intensity interval Hydrogynmastics

    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.

    Also known as: HIIH

  • OtherHydrogynmastics Continuous Moderate

    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.

    Also known as: HCM

06

What researchers measure

Primary outcomes

  1. Aerobic Fitness

    This maximal/submaximal test will be performed on cyclergometer, Balke test.

    Time frame: three months after randomization

  2. Body Composition

    The body composition (density and percentage of body fat) will be estimated by prediction equations (JACKSON et al., 1980).

    Time frame: three months after randomization

  3. 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).

    Time frame: three months after randomization

  4. 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.

    Time frame: three months after randomization

Secondary outcomes

  1. Quality Life

    Quality of life by assessed by WHOQOL-breaf

    Time frame: three months after randomization

  2. Functionality

    Functionality will be assessed by IVCF-20

    Time frame: three months after randomization

  3. Perception of Improvement

    Perception of Improvement will be measured by an Likert-type Improvement Scale

    Time frame: three months after randomization

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Dec 2023, 59 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2017
First posted
Sep 26, 2017
StartActual
Jan 1, 2019
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
May 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03293056
Lead sponsor
Universidade Federal do vale do São Francisco
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Rodrigo Gustavo da Silva Carvalho (Rodrigo Gustavo da Silva Carvalho, Universidade Federal do vale do São Francisco) — Principal investigator
First posted
Sep 26, 2017
Start date
Jan 1, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 11, 2023

Study contacts

Rodrigo GS Carvalho, PhD
Contact
rodrigo.carvalho@univasf.edu.br
8721016856

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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