Aquatic Exercise for Cognition and Mobility in Older Adults

Study Overview
=================
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.

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

Conditions
-----------------
Aging Well, Aging Problems, Cognitive Change, Gait, Unsteady, Mobility Limitation

Intervention / Treatment
-----------------
* Behavioral: Aquatic Integrated Cognitive Motor Training


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic Exercise Group<br>Aquatic class 45 minutes, 3 times a week, for 8 weeks | Behavioral: Aquatic Integrated Cognitive Motor Training<br>* Aquatic exercise class with focus on cognitive and physical exercise<br>|
| No Intervention: Control Group<br>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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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). | 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). | 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). | Measures taken at baseline and again at approximately 9-10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aquatic exercise, Fall prevention, Functional mobility