AgingNCT05107817
Aquatic Exercise and Reactive Balance
A study testing Exercise intervention in people with Aging and Aged, run by Eadric Bressel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Aged, Accidental Falls
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging, Aged, Accidental Falls, Postural Balance, Exercise, Exercise Therapy
- Being tested
- Exercise intervention
- Keywords
- Reactive balance, Aquatic exercise, Aquatic therapy, Fall prevention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionOther
A ball catching and throwing exercise.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Exercise group | Experimental | Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task in water. Receives: Other: Exercise intervention |
| Land Exercise group | Active comparator | Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task on dry land. Receives: Other: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time measures (REACH)
Hand contact time during REACH following the cable release will be calculated.
Measured: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP1)
Foot-off time during STEP following the cable release will be calculated.
Measured: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP2)
Foot contact time during STEP following the cable release will be calculated.
Measured: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Rapid response accuracy
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.
Measured: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Mini-Balance Evaluation Systems Test
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).
Measured: Immediately before the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (REACH)
Hand contact time during REACH following the cable release will be calculated.
Measured: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP1)
Foot-off time during STEP following the cable release will be calculated.
Measured: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP2)
Foot contact time during STEP following the cable release will be calculated.
Measured: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Rapid response accuracy
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.
Measured: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Mini-Balance Evaluation Systems Test
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).
Measured: Immediately after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (REACH)
Hand contact time during REACH following the cable release will be calculated.
Measured: One week after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP1)
Foot-off time during STEP following the cable release will be calculated.
Measured: One week after the intervention. Duration of each assessment will be 15 minutes.
Reaction time measures (STEP2)
Foot contact time during STEP following the cable release will be calculated.
Measured: One week after the intervention. Duration of each assessment will be 15 minutes.
Rapid response accuracy
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.
Measured: One week after the intervention. Duration of each assessment will be 15 minutes.
Mini-Balance Evaluation Systems Test
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).
Measured: One week after the intervention. Duration of each assessment will be 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study startJan 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eadric Bressel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eadric Bressel, Utah State University
- Investigators
- Eadric Bressel, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107817
- Sponsor's protocol ID
- 12227
- Status last verified
- Apr 2025
- First submitted
- 14 Oct 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any individual participant data collected in this study will not be shared with other researchers to follow the HIPAA Privacy Rule.
Publications
Bolton DAE, Mansour M. A Modified Lean and Release Technique to Emphasize Response Inhibition and Action Selection in Reactive Balance. J Vis Exp. 2020 Mar 19;(157):10.3791/60688. doi: 10.3791/60688.
PubMed 32250359
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catching and Throwing Exercises to Improve Reactive Balance: A Randomized Controlled Trial Protocol for the Comparison of Aquatic and Dry-land Training Environments
- ClinicalTrials.gov ID
- NCT05107817
- Acronym / sponsor ID
- 12227
- Conditions
- Aging, Aged, Accidental Falls, Postural Balance, Exercise, Exercise Therapy
- Keywords
- Reactive balance, Aquatic exercise, Aquatic therapy, Fall prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Eadric BresselUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Exercise group | Experimental | Other: Exercise interventionParticipants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task in water. |
| Land Exercise group | Active comparator | Other: Exercise interventionParticipants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task on dry land. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionA ball catching and throwing exercise. | Other | Aquatic Exercise group, Land Exercise group |
Primary outcome
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.
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.
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 32250359Bolton DAE, Mansour M. A Modified Lean and Release Technique to Emphasize Response Inhibition and Action Selection in Reactive Balance. J Vis Exp. 2020 Mar 19;(157):10.3791/60688. doi: 10.3791/60688.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Any individual participant data collected in this study will not be shared with other researchers to follow the HIPAA Privacy Rule.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eadric Bressel principal investigator
Utah State University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Aging and Aged, run by Eadric Bressel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youngwook Kim (4352945504, youngwook.kim@usu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time measures (REACH) (time frame: Immediately before the intervention. Duration of each assessment will be 15 minutes.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05107817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.