Aging WellNCT05501249
Aquatic Exercise for Cognition and Mobility in Older Adults
A study testing Aquatic Integrated Cognitive Motor Training in people with Aging Well and Aging Problems, run by Emily Dunlap at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of an aquatic exercise program on cognition and physical function of older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well, Aging Problems, Cognitive Change
- What is being tested?
- Aquatic Integrated Cognitive Motor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- History of dementia or Alzheimer's
- Contraindication to exercise or pool immersion (e.g., unstable cardiovascular conditions, fever, diarrhea, aqua-phobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: 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.
- Being tested
- Aquatic Integrated Cognitive Motor Training
- Keywords
- Aquatic exercise, Fall prevention, Functional mobility
- Medical subject headings
- Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Integrated Cognitive Motor TrainingBehavioural
Aquatic exercise class with focus on cognitive and physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Exercise Group | Experimental | Aquatic class 45 minutes, 3 times a week, for 8 weeks Receives: Behavioral: Aquatic Integrated Cognitive Motor Training |
| Control Group | No intervention | Usual care for 8 weeks and one hour education session on fall prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Effect Test: Change from baseline to the end of intervention/control period
Measure of working memory and attention
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Blood pressure and heart rate taken after 5 min supine, immediately upon standing, and 2 min after standing
Measured: Measures taken at baseline and again at approximately 9-10 weeks
Anthropometric measurements: Change from baseline to the end of intervention/control period
Height and weight
Measured: Measures taken at baseline and again at approximately 9-10 weeks
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
Measured: 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
An 11 point scale for level of pain from 0 (no pain) to 10 (severe pain).
Measured: 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
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).
Measured: 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
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).
Measured: Measures taken at baseline and again at approximately 9-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Feb 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emily Dunlap
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emily Dunlap, University of Texas at Austin
- Investigators
- Emily Dunlap, BS, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501249
- Sponsor's protocol ID
- STUDY00001403
- Status last verified
- Feb 2023
- First submitted
- 10 Aug 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of deidentified individual participant data will be available upon reasonable request.
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.
PubMed 24553298Bressel 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.
PubMed 29738406Parfitt 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.
PubMed 28166116Pugh 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.
PubMed 24977699Kang 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.
PubMed 31954186Commandeur 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.
PubMed 30195218de 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.
PubMed 28469588Doi 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.
PubMed 25467636Nissim 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.
PubMed 30775818Sato 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.
PubMed 24965855
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic Integrated Cognitive Motor Training on Cognition and Mobility in Older Adults
- ClinicalTrials.gov ID
- NCT05501249
- Acronym / sponsor ID
- STUDY00001403
- Keywords
- Aquatic exercise, Fall prevention, Functional mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emily DunlapUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of an aquatic exercise program on cognition and physical function of older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Exercise Group | Experimental | Behavioral: Aquatic Integrated Cognitive Motor TrainingAquatic class 45 minutes, 3 times a week, for 8 weeks |
| Control Group | No intervention | –Usual care for 8 weeks and one hour education session on fall prevention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- History of dementia or Alzheimer's
- Contraindication to exercise or pool immersion (e.g., unstable cardiovascular conditions, fever, diarrhea, aqua-phobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic Integrated Cognitive Motor TrainingAquatic exercise class with focus on cognitive and physical exercise | Behavioural | Aquatic Exercise Group |
Primary outcome
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
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
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
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.
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 24553298Carter 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.
- Background: PubMed 29738406Bressel 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.
- Background: PubMed 28166116Parfitt 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.
- Background: PubMed 24977699Pugh 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.
- Background: PubMed 31954186Kang 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.
- Background: PubMed 30195218Commandeur 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.
- Background: PubMed 28469588de 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.
- Background: PubMed 25467636Doi 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.
- Background: PubMed 30775818Nissim 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.
- Background: PubMed 24965855Sato 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.
- Individual participant dataSharing planned: Yes. Sharing of deidentified individual participant data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Dunlap, BS principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Integrated Cognitive Motor Training in people with Aging Well and Aging Problems, run by Emily Dunlap at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501249, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.