NCT05107817

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jan 2026

Status
not yet recruiting

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 Progress21%
Jan 2026Sep 2027

First Submitted

Initial submission to the registry

October 14, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
4.2 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

October 14, 2021

Last Update Submit

April 3, 2025

Conditions

Keywords

Reactive balanceAquatic exerciseAquatic therapyFall prevention

Outcome Measures

Primary Outcomes (15)

  • Reaction time measures (REACH)

    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)

    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)

    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

    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

    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)

    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)

    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)

    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

    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

    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)

    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)

    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)

    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

    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

    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.

Study Arms (2)

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.

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.

Other: Exercise intervention

Interventions

A ball catching and throwing exercise.

Aquatic Exercise groupLand Exercise group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32250359BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Eadric Bressel

    Utah State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 14, 2021

First Posted

November 4, 2021

Study Start

January 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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