NCT06529354

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 15, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

Aquatic exerciseIntensityPhysical fitnessHealth-relatedQuality of life

Outcome Measures

Primary Outcomes (13)

  • 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.

    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.

    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.

    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.

    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.

    Baseline and week 25

  • Change from Baseline in fat mass percentage at 24 weeks

    Baseline and week 25

  • Change from Baseline in fat-free mass at 24 weeks

    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.

    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.

    Baseline and week 25

  • Change from Baseline in total cholesterol at 24 weeks

    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.

    Baseline and week 25

  • Change from Baseline in systolic blood pressure at 24 weeks

    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.

    Baseline and week 25

Secondary Outcomes (1)

  • Change from Baseline in quality of life at 24 weeks

    Baseline and week 25

Study Arms (2)

Moderate-intensity Group

EXPERIMENTAL

Participants engaged in 45-minute water aerobics sessions twice a week for 24 weeks at moderate intensities.

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.

Behavioral: High-intensity Group

Interventions

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.

Moderate-intensity Group

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.

High-intensity Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age

You may not qualify if:

  • taking part in another physical exercise program
  • being recently hospitalized
  • having severe motor or cognitive problems
  • having any medical restrictions on physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tramagal Municipal Swimming Pool

Abrantes, 2205-700, Portugal

Location

Study Officials

  • Luís Faíl

    University of Beira Interior

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 31, 2024

Study Start

January 30, 2023

Primary Completion

July 21, 2023

Study Completion

July 28, 2023

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations