HIIH Versus HMC: Randomized Clinical Trial (HIITxHMC)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy People
• Intervention / Treatment: Other: High-intensity interval Hydrogynmastics; Other: Hydrogynmastics Continuous Moderate

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo GS Carvalho, PhD; Phone Number: 8721016856; Email: rodrigo.carvalho@univasf.edu.br

Study Locations

• Brazil
  • Pernambuco
    • Petrolina, Pernambuco, Brazil, 56304917
      • Recruiting
      • Physical Education College
      • Contact: Rodrigo GS Carvalho, PhD; Phone Number: 8721016856; Email: rodrigo.carvalho@univasf.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity Interval Hydrogynmastics; High-intensity Interval training Hydrogynmastics, 2x/week, for 3 months.	Other: High-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.; Other Names: HIIH
Active Comparator: Hydrogynmastics Continuous Moderate; Hydrogynmastics Continuous Moderate training (HCM), 2x/week, for 3 months.	Other: Hydrogynmastics 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.; Other Names: HCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic Fitness	This maximal/submaximal test will be performed on cyclergometer, Balke test.	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).	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).	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.	three months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	Functionality will be assessed by IVCF-20	three months after randomization
Perception of Improvement	Perception of Improvement will be measured by an Likert-type Improvement Scale	three months after randomization
Quality Life	Quality of life by assessed by WHOQOL-breaf	three months after randomization

Collaborators and Investigators

• Sponsor: Universidade Federal do vale do São Francisco
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: training; aquatic; aerobic exercises
• Other Study ID Numbers: 012017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No