- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03629912
Bingocize: A Novel Mobile Application for Older Adult Health (Bingocize)
Bingocize: A Novel Mobile Application to Help Maintain or Improve Older Adults' Health, Function, and Cognition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Kentucky
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Dixon, Kentucky, United States, 42409
- Webster County Senior Center
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Tennessee
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Henderson, Tennessee, United States, 38340
- Chester County Senior Center
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Johnson City, Tennessee, United States, 37601
- Johnson County Senior Center
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Scotts Hill, Tennessee, United States, 38374
- Scotts Hill Senior Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Normal or corrected normal vision
- Mobility (i.e., not wheelchair bound)
- English is native language
- Minimum physical standards (e.g., ability to walk at least 10 meters)
- No structured physical activity programs >150 minutes/week in last 6 months
Exclusion Criteria:
- Severe neurological impairments (e.g., Parkinson's)
- Colorblindness
- Dementia
Study Plan
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: Exercise + Health Education + Bingo
Socially-Based Exercise Intervention for Older Adults.
Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition.
|
A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors
Other Names:
|
Active Comparator: Exercise + Bingo
Socially-Based Exercise Intervention for Older Adults.
Participants use the Bingocize app incorporating exercises ONLY.
|
A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors
Other Names:
|
Active Comparator: Health Education + Bingo
Socially-Based Exercise Intervention for Older Adults.
Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY.
|
A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors
Other Names:
|
No Intervention: Bingo Only
Participants use the Bingocize app to play bingo only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive Function Inhibition Measure 1: Flanker Task
Time Frame: Baseline and 12 Weeks
|
Flanker Task designed to measure inhibition, part of the EXAMINER Battery (for scoring method, see References section). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better. |
Baseline and 12 Weeks
|
Executive Function Measure: Updating Verbal Working Memory
Time Frame: Baseline and 12 Weeks
|
Dot Counting Task designed to measure verbal working memory, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score is the total number of items correctly recalled across all six trials. Minimum=0, Maximum=27, higher = better. |
Baseline and 12 Weeks
|
Executive Function Measure: Set Shifting Task
Time Frame: Baseline and 12 Weeks
|
Set Shifting Task designed to measure attention during task switching, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better. |
Baseline and 12 Weeks
|
Executive Function Measure: Verbal Fluency
Time Frame: Baseline and 12 Weeks
|
Verbal Fluency Task designed to measure fluency, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that represents the total number of words correctly recalled in two tasks: phonemic (letter) and semantic (category). Minimum=0, Maximum=unlimited, higher = better. |
Baseline and 12 Weeks
|
Chair Stands: Change in Lower-body Muscular Strength
Time Frame: Baseline and 12 Weeks
|
number of completed chair stands in 30 seconds, minimum=0, higher = better
|
Baseline and 12 Weeks
|
Change in Dynamic Balance: 360 Degree Turns
Time Frame: Baseline and 12 Weeks
|
360 degree turns: time to complete.
No minimum or maximum value set.
Lower = better.
|
Baseline and 12 Weeks
|
Executive Function Measure of Inhibition: Continuous Performance Test
Time Frame: Baseline and 12 Weeks
|
Continuance Performance Task is classic response inhibition task, part of the EXAMINER Battery (for scoring method, see References). The score here represents the number of trials out of 100 that the participant responded correctly (i.e., either successfully responded or successfully inhibited a response). Minimum=0 Maximum=100, higher = better. |
Baseline and 12 Weeks
|
Timed Up and Go (TUG) Test: Change in Dynamic Balance
Time Frame: Baseline and 12 Weeks
|
Timed Up and Go (TUG) Test used to assess mobility and risk for falling.
Number of seconds needed to stand up from a chair, walk 10 feet, turn around, walk back 10 feet, and sit back down in chair.
No minimum or maximum value is set.
Lower = better.
|
Baseline and 12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Weight
Time Frame: Baseline and 12 Weeks
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Weight calculated by scale measurement
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Baseline and 12 Weeks
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Crystallized Knowledge of Fall Risks and Proper Diet/Nutrition
Time Frame: Baseline and 12 Weeks
|
Multiple-choice questions constructed by project investigators that cover: recognition of health terms, weight management, proper diet, bone health, environmental fall risks, careful movement.
Unit of measure = number correct.
Minimum = 0, Maximum = 30.
Higher = better.
|
Baseline and 12 Weeks
|
Grip Strength: Changes in Upper Body Muscular Strength
Time Frame: Baseline and 12 Weeks
|
Grip strength tests using a hand-held dynamometer.
No minimum or maximum set.
Higher = better.
|
Baseline and 12 Weeks
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Fall Efficacy Scale
Time Frame: Baseline and 12 Weeks
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Self-reported scale assessing confidence in doing activities that may be perceived as having risk for falling (see References). Minimum = 10, Maximum = 100. Lower = better. |
Baseline and 12 Weeks
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Changes in Dietary Habits: Total Added Sugar Intake
Time Frame: Baseline and 12 Weeks
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Dietary Screener Questionnaire (DSQ) assessing total added sugar intake over past 30 days
|
Baseline and 12 Weeks
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Changes in Quality of Life
Time Frame: Baseline and 12 Weeks
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CDC Health related quality of life measure item 1 (general health). 1 = Excellent, 5 = Poor.
Lower = Better.
|
Baseline and 12 Weeks
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Systolic Blood Pressure
Time Frame: Baseline and 12 Weeks
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Systolic Blood pressure calculated by sphygmomanometer.
|
Baseline and 12 Weeks
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Diastolic Blood Pressure
Time Frame: Baseline and 12 Weeks
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Diastolic Blood pressure calculated by sphygmomanometer
|
Baseline and 12 Weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew C Shake, PhD, Western Kentucky University and Center for Applied Science in Health and Aging
- Principal Investigator: Jason Crandall, PhD, Western Kentucky University and Center for Applied Science in Health and Aging
Publications and helpful links
General Publications
- Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
- Kramer JH, Mungas D, Possin KL, Rankin KP, Boxer AL, Rosen HJ, Bostrom A, Sinha L, Berhel A, Widmeyer M. NIH EXAMINER: conceptualization and development of an executive function battery. J Int Neuropsychol Soc. 2014 Jan;20(1):11-9. doi: 10.1017/S1355617713001094. Epub 2013 Oct 8.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Neurologic Manifestations
- Neurocognitive Disorders
- Endocrine System Diseases
- Diabetes Mellitus
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Cognition Disorders
- Muscular Atrophy
- Atrophy
- Diabetes Mellitus, Type 2
- Cognitive Dysfunction
- Sarcopenia
- Arteriosclerosis
Other Study ID Numbers
- IRB 18-048
- R15AG055906 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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