Aquatic Exercise and Reactive Balance

April 3, 2025 updated by: Eadric Bressel

Catching and Throwing Exercises to Improve Reactive Balance: A Randomized Controlled Trial Protocol for the Comparison of Aquatic and Dry-land Training Environments

The present clinical trial aims to identify if skills acquired during aquatic exercise are more effectively transferred to a reactive balance task than land exercise. This study is designed as a double-blinded, randomized controlled clinical trial. Forty-four older adults aged 60 years or above who meet the eligibility criteria will be recruited and randomized into an aquatic exercise group or land exercise group. Each group will participate in the same balance training exercise during a single session that includes a ball throwing and catching task. A modified lean-and-release test will be implemented on land immediately before, after, and one week after the training session. The outcomes will include reaction time, rapid response accuracy, and mini-BESTest scores obtained from stepping and grasping reactions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During the modified lean-and-release test, there are two possible settings: 1) the leg block is placed in front of both legs, and a safety handle is uncovered; or 2) the leg block is removed, and the safety handle is covered. The leg block and handle cover will be controlled via computer-triggered, servo motors. The testing session will be comprised of three blocks: 1) REACH (grasping a safety handle using their right hand while maintaining both feet fixed), 2) STEP (stepping forward using any leg), and 3) RANDOM (random variations of STEP and REACH).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ability to stand using a double-leg stance for one minute of time
  • Ability to walk independently
  • Normal or corrected to normal vision
  • Normal or corrected to normal hearing based on a qualitative assessment

Exclusion Criteria:

  • Any neurological or musculoskeletal disorders that may inhibit the participation in the training and testing protocols
  • A concussion within the past one year before the participation
  • Any cognitive deficiencies (e.g., memory, concentration, or attention disorder)
  • One or more 'yes' answered on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Fear of water

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aquatic Exercise group
Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task in water.
Other: Exercise intervention
A ball catching and throwing exercise.
Active Comparator: Land Exercise group
Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task on dry land.
Other: Exercise intervention
A ball catching and throwing exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reaction time measures (REACH)
Time Frame: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Hand contact time during REACH following the cable release will be calculated.
Immediately before the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP1)
Time Frame: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Foot-off time during STEP following the cable release will be calculated.
Immediately before the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP2)
Time Frame: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Foot contact time during STEP following the cable release will be calculated.
Immediately before the intervention. Duration of each assessment will be 15 minutes.
Rapid response accuracy
Time Frame: Immediately before the intervention. Duration of each assessment will be 15 minutes.
For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation.
Immediately before the intervention. Duration of each assessment will be 15 minutes.
Mini-Balance Evaluation Systems Test
Time Frame: Immediately before the intervention. Duration of each assessment will be 15 minutes.
During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best).
Immediately before the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (REACH)
Time Frame: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Hand contact time during REACH following the cable release will be calculated.
Immediately after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP1)
Time Frame: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Foot-off time during STEP following the cable release will be calculated.
Immediately after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP2)
Time Frame: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Foot contact time during STEP following the cable release will be calculated.
Immediately after the intervention. Duration of each assessment will be 15 minutes.
Rapid response accuracy
Time Frame: Immediately after the intervention. Duration of each assessment will be 15 minutes.
For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation.
Immediately after the intervention. Duration of each assessment will be 15 minutes.
Mini-Balance Evaluation Systems Test
Time Frame: Immediately after the intervention. Duration of each assessment will be 15 minutes.
During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best).
Immediately after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (REACH)
Time Frame: One week after the intervention. Duration of each assessment will be 15 minutes.
Hand contact time during REACH following the cable release will be calculated.
One week after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP1)
Time Frame: One week after the intervention. Duration of each assessment will be 15 minutes.
Foot-off time during STEP following the cable release will be calculated.
One week after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP2)
Time Frame: One week after the intervention. Duration of each assessment will be 15 minutes.
Foot contact time during STEP following the cable release will be calculated.
One week after the intervention. Duration of each assessment will be 15 minutes.
Rapid response accuracy
Time Frame: One week after the intervention. Duration of each assessment will be 15 minutes.
For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation.
One week after the intervention. Duration of each assessment will be 15 minutes.
Mini-Balance Evaluation Systems Test
Time Frame: One week after the intervention. Duration of each assessment will be 15 minutes.
During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best).
One week after the intervention. Duration of each assessment will be 15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eadric Bressel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eadric Bressel, Utah State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12227 (Company Internal)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Any individual participant data collected in this study will not be shared with other researchers to follow the HIPAA Privacy Rule.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings