- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509217
12 Weeks of Water Aerobics at Various Intensities for Adults and Older Adults
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?
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Abrantes, Portugal, 2205-700
- Tramagal Municipal Swimming Pool
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years of age
Exclusion Criteria:
- taking part in another physical exercise program
- being recently hospitalized
- having severe motor or cognitive problems
- having any medical restrictions on physical exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moderate-intensity Group
Participants performed water aerobics at moderate intensities.
Water aerobics classes lasted approximately 45 minutes and were held twice a week for 12 weeks
|
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.
|
|
Experimental: High-intensity Group
Participants performed water aerobics at high intensities.
Water aerobics classes lasted approximately 45 minutes and were held twice a week for 12 weeks
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and week 12
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|
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.
|
Baseline and week 12
|
|
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.
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Baseline and week 12
|
|
Change from Baseline in endurance strength of upper limbs at 12 weeks
Time Frame: Baseline and week 12
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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.
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Baseline and week 12
|
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Change from Baseline in body mass at 12 weeks
Time Frame: Baseline and week 12
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A bioimpedance balance was used.
For the correct extraction of this test, participants were barefoot and dressed in as little clothing as possible.
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Baseline and week 12
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Change from Baseline in fat mass percentage at 12 weeks
Time Frame: Baseline and week 12
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Baseline and week 12
|
|
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Change from Baseline in fat-free mass at 12 weeks
Time Frame: Baseline and week 12
|
Baseline and week 12
|
|
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Change from Baseline in body mass index at 12 weeks
Time Frame: Baseline and week 12
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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.
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Baseline and week 12
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Change from Baseline in triglycerides at 12 weeks
Time Frame: Baseline and week 12
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Blood samples were collected before exercise (after a 15-minute rest period) and at least 2 hours after the last meal.
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Baseline and week 12
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Change from Baseline in total cholesterol at 12 weeks
Time Frame: Baseline and week 12
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Baseline and week 12
|
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Change from Baseline in diastolic blood pressure at 12 weeks
Time Frame: Baseline and week 12
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This measure was assessed using an automatic blood pressure monitor, after the participant was seated and resting for at least 20 minutes.
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Baseline and week 12
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Change from Baseline in systolic blood pressure at 12 weeks
Time Frame: Baseline and week 12
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Baseline and week 12
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Change from Baseline in resting heart rate at 12 weeks
Time Frame: Baseline and week 12
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This measure was assessed using an automatic blood pressure monitor, after the participant was seated and resting for at least 20 minutes.
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Baseline and week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in quality of life at 12 weeks
Time Frame: Baseline and week 12
|
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.
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Baseline and week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luís Faíl, University of Beira Interior
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ID1475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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