- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05107817
Aquatic Exercise and Reactive Balance
April 19, 2024 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
Not yet recruiting
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
44
Phase
- 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
- Name: Youngwook Kim
- Phone Number: 4352945504
- Email: youngwook.kim@usu.edu
Study Contact Backup
- Name: Eadric Bressel
- Phone Number: 4357977216
- Email: eadric.bressel@usu.edu
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
A ball catching and throwing exercise.
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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.
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)
January 1, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
October 14, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 4, 2021
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID 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
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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