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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03629912
Other study ID # IRB 18-048
Secondary ID R15AG055906
Status Completed
Phase N/A
First received
Last updated
Start date August 13, 2018
Est. completion date May 13, 2022

Study information

Verified date February 2024
Source Western Kentucky University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study tests the effectiveness of using a new mobile application (Bingocize®) to improve older adults' (a) adherence to an engaging exercise program, and (b) aspects of functional performance, health knowledge, dietary habits, and cognition.


Description:

Health-promoting interventions designed to improve physical and mental fitness can help reduce health care costs; they can also help maintain, or even improve, older adults' quality of life. However, getting older adults to adhere to health-promoting exercise interventions remains difficult because such programs are often perceived as being time-consuming, painful, or unenjoyable. The present study's objective is to investigate the effectiveness of a novel technological exercise intervention program for older adults (Bingocize); in doing so, the program has the potential to improve older adults' independence and quality of life. Older adults will participate in a pre/post-intervention design with random assignment to either the experimental or one of three comparison/control groups; each group will play Bingocize in a social setting with other older adults. Participants in the experimental group will use the app to engage in twice-weekly Bingocize sessions for twelve weeks (i.e., Bingo+Exercise+Health Education); control groups will also use the app for twelve weeks but for either health education-only, exercise-only, or bingo-only.


Recruitment information / eligibility

Status Completed
Enrollment 241
Est. completion date May 13, 2022
Est. primary completion date May 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility 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 Design


Intervention

Behavioral:
Socially-Based Exercise Intervention for Older Adults
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

Locations

Country Name City State
United States Webster County Senior Center Dixon Kentucky
United States Chester County Senior Center Henderson Tennessee
United States Johnson County Senior Center Johnson City Tennessee
United States Scotts Hill Senior Center Scotts Hill Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Western Kentucky University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/S135561771 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Executive Function Inhibition Measure 1: Flanker Task 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
Primary Executive Function Measure: Updating Verbal Working Memory 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
Primary Executive Function Measure: Set Shifting Task 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
Primary Executive Function Measure: Verbal Fluency 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
Primary Chair Stands: Change in Lower-body Muscular Strength number of completed chair stands in 30 seconds, minimum=0, higher = better Baseline and 12 Weeks
Primary Change in Dynamic Balance: 360 Degree Turns 360 degree turns: time to complete. No minimum or maximum value set. Lower = better. Baseline and 12 Weeks
Primary Executive Function Measure of Inhibition: Continuous Performance Test 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
Primary Timed Up and Go (TUG) Test: Change in Dynamic Balance 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 Crystallized Knowledge of Fall Risks and Proper Diet/Nutrition 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
Secondary Grip Strength: Changes in Upper Body Muscular Strength Grip strength tests using a hand-held dynamometer. No minimum or maximum set. Higher = better. Baseline and 12 Weeks
Secondary Fall Efficacy Scale 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
Secondary Changes in Dietary Habits: Total Added Sugar Intake Dietary Screener Questionnaire (DSQ) assessing total added sugar intake over past 30 days Baseline and 12 Weeks
Secondary Changes in Quality of Life CDC Health related quality of life measure item 1 (general health). 1 = Excellent, 5 = Poor. Lower = Better. Baseline and 12 Weeks
Secondary Changes in Weight Weight calculated by scale measurement Baseline and 12 Weeks
Secondary Systolic Blood Pressure Systolic Blood pressure calculated by sphygmomanometer. Baseline and 12 Weeks
Secondary Diastolic Blood Pressure Diastolic Blood pressure calculated by sphygmomanometer Baseline and 12 Weeks
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