- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05501249
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Aquatic Exercise Group
Aquatic class 45 minutes, 3 times a week, for 8 weeks
|
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
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
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
Investigators
- 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
- Carter HH, Spence AL, Pugh CJ, Ainslie P, Naylor LH, Green DJ. Cardiovascular responses to water immersion in humans: impact on cerebral perfusion. Am J Physiol Regul Integr Comp Physiol. 2014 May;306(9):R636-40. doi: 10.1152/ajpregu.00516.2013. Epub 2014 Feb 19.
- Bressel E, Louder TJ, Raikes AC, Alphonsa S, Kyvelidou A. Water Immersion Affects Episodic Memory and Postural Control in Healthy Older Adults. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E1-E6. doi: 10.1519/JPT.0000000000000192.
- Parfitt R, Hensman MY, Lucas SJE. Cerebral Blood Flow Responses to Aquatic Treadmill Exercise. Med Sci Sports Exerc. 2017 Jul;49(7):1305-1312. doi: 10.1249/MSS.0000000000001230.
- Pugh CJ, Sprung VS, Ono K, Spence AL, Thijssen DH, Carter HH, Green DJ. The effect of water immersion during exercise on cerebral blood flow. Med Sci Sports Exerc. 2015 Feb;47(2):299-306. doi: 10.1249/MSS.0000000000000422.
- Kang DW, Bressel E, Kim DY. Effects of aquatic exercise on insulin-like growth factor-1, brain-derived neurotrophic factor, vascular endothelial growth factor, and cognitive function in elderly women. Exp Gerontol. 2020 Apr;132:110842. doi: 10.1016/j.exger.2020.110842. Epub 2020 Jan 15.
- Commandeur D, Klimstra MD, MacDonald S, Inouye K, Cox M, Chan D, Hundza SR. Difference scores between single-task and dual-task gait measures are better than clinical measures for detection of fall-risk in community-dwelling older adults. Gait Posture. 2018 Oct;66:155-159. doi: 10.1016/j.gaitpost.2018.08.020. Epub 2018 Aug 23.
- de Assis GG, de Almondes KM. Exercise-dependent BDNF as a Modulatory Factor for the Executive Processing of Individuals in Course of Cognitive Decline. A Systematic Review. Front Psychol. 2017 Apr 19;8:584. doi: 10.3389/fpsyg.2017.00584. eCollection 2017.
- Doi T, Shimada H, Makizako H, Tsutsumimoto K, Hotta R, Nakakubo S, Suzuki T. Association of insulin-like growth factor-1 with mild cognitive impairment and slow gait speed. Neurobiol Aging. 2015 Feb;36(2):942-7. doi: 10.1016/j.neurobiolaging.2014.10.035. Epub 2014 Nov 1.
- Nissim M, Hutzler Y, Goldstein A. A walk on water: comparing the influence of Ai Chi and Tai Chi on fall risk and verbal working memory in ageing people with intellectual disabilities - a randomised controlled trial. J Intellect Disabil Res. 2019 Jun;63(6):603-613. doi: 10.1111/jir.12602. Epub 2019 Feb 18.
- Sato D, Seko C, Hashitomi T, Sengoku Y, Nomura T. Differential effects of water-based exercise on the cognitive function in independent elderly adults. Aging Clin Exp Res. 2015 Apr;27(2):149-59. doi: 10.1007/s40520-014-0252-9. Epub 2014 Jun 26.
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)
February 1, 2022
Primary Completion (Actual)
December 12, 2022
Study Completion (Actual)
December 12, 2022
Study Registration Dates
First Submitted
August 10, 2022
First Submitted That Met QC Criteria
August 11, 2022
First Posted (Actual)
August 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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