NCT05501249

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

August 10, 2022

Last Update Submit

February 27, 2023

Conditions

Keywords

Aquatic exerciseFall preventionFunctional mobility

Outcome Measures

Primary Outcomes (5)

  • Stroop Effect Test: Change from baseline to the end of intervention/control period

    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

    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

    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

    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

    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 Outcomes (6)

  • Vital Sign measurements: Change from baseline to the end of intervention/control period

    Measures taken at baseline and again at approximately 9-10 weeks

  • Anthropometric measurements: Change from baseline to the end of intervention/control period

    Measures taken at baseline and again at approximately 9-10 weeks

  • Neurotrophic Growth Factors: Change from baseline to the end of intervention/control period

    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

    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

    Measures taken at baseline and again at approximately 9-10 weeks

  • +1 more secondary outcomes

Study Arms (2)

Aquatic Exercise Group

EXPERIMENTAL

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

Behavioral: Aquatic Integrated Cognitive Motor Training

Control Group

NO INTERVENTION

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

Interventions

Aquatic exercise class with focus on cognitive and physical exercise

Aquatic Exercise Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (10)

  • 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.

    PMID: 24553298BACKGROUND
  • 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.

    PMID: 29738406BACKGROUND
  • 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.

    PMID: 28166116BACKGROUND
  • 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.

    PMID: 24977699BACKGROUND
  • 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.

    PMID: 31954186BACKGROUND
  • 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.

    PMID: 30195218BACKGROUND
  • 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.

    PMID: 28469588BACKGROUND
  • 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.

    PMID: 25467636BACKGROUND
  • 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.

    PMID: 30775818BACKGROUND
  • 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.

    PMID: 24965855BACKGROUND

MeSH Terms

Conditions

Gait Disorders, NeurologicMobility Limitation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emily Dunlap, BS

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 15, 2022

Study Start

February 1, 2022

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
The data will become available after publication
Access Criteria
Data will be available to researcher for meta-analysis purpose upon reasonable request.

Locations