Aquatic Exercise for Cognition and Mobility in Older Adults

February 27, 2023 updated by: Emily Dunlap

Effects of Aquatic Integrated Cognitive Motor Training on Cognition and Mobility in Older Adults

The purpose of this study is to assess the effects of an aquatic exercise program on cognition and physical function of older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
25

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 Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • The University of Texas at Austin

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to ambulate 100 ft independently with or without assistive device
  • Score greater than or equal to 3 on the Mini-Cog Test
  • Stable medical condition within one month prior to the study
  • Stable exercise program within one month prior to the study
  • Available during study testing and group class times
  • COVID-19 vaccination
  • Permission from medical provider to participate in the study

Exclusion Criteria:

  • History of dementia or Alzheimer's
  • Contraindication to exercise or pool immersion (e.g., unstable cardiovascular conditions, fever, diarrhea, aqua-phobia)

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: None (Open Label)

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
Aquatic class 45 minutes, 3 times a week, for 8 weeks
Behavioral: Aquatic Integrated Cognitive Motor Training
Aquatic exercise class with focus on cognitive and physical exercise
No Intervention: Control Group
Usual care for 8 weeks and one hour education session on fall prevention.

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
Stroop Effect Test: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
Measure of working memory and attention
Measures taken at baseline and again at approximately 9-10 weeks
Trail Making Test A and B: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
Measure of visual scanning and working memory
Measures taken at baseline and again at approximately 9-10 weeks
Digit Backwards Test : Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
Measure of working memory capacity
Measures taken at baseline and again at approximately 9-10 weeks
Gait Measurements: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
4 gait conditions (single task gait, dual task gait with head turns, dual task gait with head nods, and dual task gait count backwards by serial 7s). Gait measures collected with Strideway Gait Analysis System.
Measures taken at baseline and again at approximately 9-10 weeks
Functional Outcome Measures: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
Timed Up and Go Test, Cognitive Timed Up and Go Test, Single Leg Balance Test, and Four Square Step Test.
Measures taken at baseline and again at approximately 9-10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vital Sign measurements: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
Blood pressure and heart rate taken after 5 min supine, immediately upon standing, and 2 min after standing
Measures taken at baseline and again at approximately 9-10 weeks
Anthropometric measurements: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
Height and weight
Measures taken at baseline and again at approximately 9-10 weeks
Neurotrophic Growth Factors: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
Serum concentration of brain derived neurotrophic factor and insulin-like growth factor 1
Measures taken at baseline and again at approximately 9-10 weeks
Numeric Pain Rating Scale: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
An 11 point scale for level of pain from 0 (no pain) to 10 (severe pain).
Measures taken at baseline and again at approximately 9-10 weeks
Global Rating of Change Questionnaire: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
A 15 point global rating scale for changes in domains, from -7 (a great deal worse); through 0 (no change) to +7 (a great deal better).
Measures taken at baseline and again at approximately 9-10 weeks
Activities-specific balance confidence scale: Change from baseline to the end of intervention/control period
Time Frame: Measures taken at baseline and again at approximately 9-10 weeks
A structured questionnaire that measures an individuals confidence performing daily activities. The minimum score is 0% (no confidence in balance) to 100% (complete confidence in balance).
Measures taken at baseline and again at approximately 9-10 weeks

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.
Emily Dunlap

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: Emily Dunlap, BS, The University of Texas at Austin

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

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 (Actual)

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.
February 1, 2022

Primary Completion (Actual)

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.
December 12, 2022

Study Completion (Actual)

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.
December 12, 2022

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).
August 10, 2022

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.
August 11, 2022

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.
August 15, 2022

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.
March 1, 2023

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.
February 27, 2023

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.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • STUDY00001403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing of deidentified individual participant data will be available upon reasonable request.

IPD Sharing Time Frame

The data will become available after publication

IPD Sharing Access Criteria

Data will be available to researcher for meta-analysis purpose upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

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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