NCT06509217

Brief 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 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable healthy

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

September 19, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 11, 2024

Last Update Submit

July 16, 2024

Conditions

Keywords

Aquatic exerciseIntensityPhysical fitnessHealth-relatedQuality of life

Outcome Measures

Primary Outcomes (13)

  • 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.

    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.

    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.

    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.

    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.

    Baseline and week 12

  • Change from Baseline in fat mass percentage at 12 weeks

    Baseline and week 12

  • Change from Baseline in fat-free mass at 12 weeks

    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.

    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.

    Baseline and week 12

  • Change from Baseline in total cholesterol at 12 weeks

    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.

    Baseline and week 12

  • Change from Baseline in systolic blood pressure at 12 weeks

    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.

    Baseline and week 12

Secondary Outcomes (1)

  • Change from Baseline in quality of life at 12 weeks

    Baseline and week 12

Study Arms (2)

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

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

Behavioral: High-intensity Group

Interventions

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.

Moderate-intensity Group

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.

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
SPONSOR INVESTIGATOR
PI Title
Guest Assistant

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 19, 2024

Study Start

September 19, 2022

Primary Completion

December 16, 2022

Study Completion

December 23, 2022

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations