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Aquatic Exercise for Cognition and Mobility in Older Adults

Primary Purpose

Aging Well, Aging Problems, Cognitive Change

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquatic Integrated Cognitive Motor Training
Sponsored by
Emily Dunlap
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging Well focused on measuring Aquatic exercise, Fall prevention, Functional mobility

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aquatic Exercise Group

Control Group

Arm Description

Aquatic class 45 minutes, 3 times a week, for 8 weeks

Usual care for 8 weeks and one hour education session on fall prevention.

Outcomes

Primary Outcome Measures

Stroop Effect Test: Change from baseline to the end of intervention/control period
Measure of working memory and attention
Trail Making Test A and B: Change from baseline to the end of intervention/control period
Measure of visual scanning and working memory
Digit Backwards Test : Change from baseline to the end of intervention/control period
Measure of working memory capacity
Gait Measurements: Change from baseline to the end of intervention/control period
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.
Functional Outcome Measures: Change from baseline to the end of intervention/control period
Timed Up and Go Test, Cognitive Timed Up and Go Test, Single Leg Balance Test, and Four Square Step Test.

Secondary Outcome Measures

Vital Sign measurements: Change from baseline to the end of intervention/control period
Blood pressure and heart rate taken after 5 min supine, immediately upon standing, and 2 min after standing
Anthropometric measurements: Change from baseline to the end of intervention/control period
Height and weight
Neurotrophic Growth Factors: Change from baseline to the end of intervention/control period
Serum concentration of brain derived neurotrophic factor and insulin-like growth factor 1
Numeric Pain Rating Scale: Change from baseline to the end of intervention/control period
An 11 point scale for level of pain from 0 (no pain) to 10 (severe pain).
Global Rating of Change Questionnaire: Change from baseline to the end of intervention/control period
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).
Activities-specific balance confidence scale: Change from baseline to the end of intervention/control period
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).

Full Information

First Posted
August 10, 2022
Last Updated
February 27, 2023
Sponsor
Emily Dunlap
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1. Study Identification

Unique Protocol Identification Number
NCT05501249
Brief Title
Aquatic Exercise for Cognition and Mobility in Older Adults
Official Title
Effects of Aquatic Integrated Cognitive Motor Training on Cognition and Mobility in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emily Dunlap

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Well, Aging Problems, Cognitive Change, Gait, Unsteady, Mobility Limitation
Keywords
Aquatic exercise, Fall prevention, Functional mobility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic Exercise Group
Arm Type
Experimental
Arm Description
Aquatic class 45 minutes, 3 times a week, for 8 weeks
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual care for 8 weeks and one hour education session on fall prevention.
Intervention Type
Behavioral
Intervention Name(s)
Aquatic Integrated Cognitive Motor Training
Intervention Description
Aquatic exercise class with focus on cognitive and physical exercise
Primary Outcome Measure Information:
Title
Stroop Effect Test: Change from baseline to the end of intervention/control period
Description
Measure of working memory and attention
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Trail Making Test A and B: Change from baseline to the end of intervention/control period
Description
Measure of visual scanning and working memory
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Digit Backwards Test : Change from baseline to the end of intervention/control period
Description
Measure of working memory capacity
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Gait Measurements: Change from baseline to the end of intervention/control period
Description
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.
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Functional Outcome Measures: Change from baseline to the end of intervention/control period
Description
Timed Up and Go Test, Cognitive Timed Up and Go Test, Single Leg Balance Test, and Four Square Step Test.
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Secondary Outcome Measure Information:
Title
Vital Sign measurements: Change from baseline to the end of intervention/control period
Description
Blood pressure and heart rate taken after 5 min supine, immediately upon standing, and 2 min after standing
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Anthropometric measurements: Change from baseline to the end of intervention/control period
Description
Height and weight
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Neurotrophic Growth Factors: Change from baseline to the end of intervention/control period
Description
Serum concentration of brain derived neurotrophic factor and insulin-like growth factor 1
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Numeric Pain Rating Scale: Change from baseline to the end of intervention/control period
Description
An 11 point scale for level of pain from 0 (no pain) to 10 (severe pain).
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Global Rating of Change Questionnaire: Change from baseline to the end of intervention/control period
Description
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).
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks
Title
Activities-specific balance confidence scale: Change from baseline to the end of intervention/control period
Description
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).
Time Frame
Measures taken at baseline and again at approximately 9-10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Dunlap, BS
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
24553298
Citation
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.
Results Reference
background
PubMed Identifier
29738406
Citation
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.
Results Reference
background
PubMed Identifier
28166116
Citation
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.
Results Reference
background
PubMed Identifier
24977699
Citation
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.
Results Reference
background
PubMed Identifier
31954186
Citation
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.
Results Reference
background
PubMed Identifier
30195218
Citation
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.
Results Reference
background
PubMed Identifier
28469588
Citation
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.
Results Reference
background
PubMed Identifier
25467636
Citation
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.
Results Reference
background
PubMed Identifier
30775818
Citation
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.
Results Reference
background
PubMed Identifier
24965855
Citation
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.
Results Reference
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Aquatic Exercise for Cognition and Mobility in Older Adults

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