NCT03629912

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

August 6, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

August 6, 2018

Results QC Date

August 4, 2023

Last Update Submit

February 13, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • Chair Stands: Change in Lower-body Muscular Strength

    number of completed chair stands in 30 seconds, minimum=0, higher = better

    Baseline and 12 Weeks

  • 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

  • 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

  • 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 Outcomes (8)

  • Crystallized Knowledge of Fall Risks and Proper Diet/Nutrition

    Baseline and 12 Weeks

  • Grip Strength: Changes in Upper Body Muscular Strength

    Baseline and 12 Weeks

  • Fall Efficacy Scale

    Baseline and 12 Weeks

  • Changes in Dietary Habits: Total Added Sugar Intake

    Baseline and 12 Weeks

  • Changes in Quality of Life

    Baseline and 12 Weeks

  • +3 more secondary outcomes

Study Arms (4)

Exercise + Health Education + Bingo

EXPERIMENTAL

Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition.

Behavioral: Socially-Based Exercise Intervention for Older Adults

Exercise + Bingo

ACTIVE COMPARATOR

Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises ONLY.

Behavioral: Socially-Based Exercise Intervention for Older Adults

Health Education + Bingo

ACTIVE COMPARATOR

Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY.

Behavioral: Socially-Based Exercise Intervention for Older Adults

Bingo Only

NO INTERVENTION

Participants use the Bingocize app to play bingo only.

Interventions

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

Also known as: Bingocize
Exercise + BingoExercise + Health Education + BingoHealth Education + Bingo

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe neurological impairments (e.g., Parkinson's)
  • Colorblindness
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Webster County Senior Center

Dixon, Kentucky, 42409, United States

Location

Chester County Senior Center

Henderson, Tennessee, 38340, United States

Location

Johnson County Senior Center

Johnson City, Tennessee, 37601, United States

Location

Scotts Hill Senior Center

Scotts Hill, Tennessee, 38374, United States

Location

Related 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/S1355617713001094. Epub 2013 Oct 8.

  • 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.

Related Links

MeSH Terms

Conditions

SarcopeniaArteriosclerosisDiabetes Mellitus, Type 2HypertensionCognitive Dysfunction

Interventions

Aging

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Limitations and Caveats

COVID-19 Pandemic began in the Middle of this Intervention, resulting in the loss of approximately 35-40% of the overall participant sample who were in the middle of the clinical trial intervention and had to withdraw from the study. Other data collection waves were started and completed before the pandemic, or started and completed after the pandemic, which introduces the possibility of history effects impacting interpretations of the data from participants who did complete the trial.

Results Point of Contact

Title
Dr. Matthew Shake
Organization
Western Kentucky University

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Staff collecting pre- and post-intervention data are masked to participant condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In each wave of the study (14 weeks per wave), participant groups are randomly assigned to one of four conditions (A,B,C,D). Condition A receives exercise + health education. Condition B receives exercise only. Condition C receives health education only. Condition D receives nothing.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychological Sciences

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 14, 2018

Study Start

August 13, 2018

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

March 12, 2024

Results First Posted

March 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Time Frame
Data will be available within 6 months after publication, and will remain available for a period of at least 3 years following completion of the clinical trial.
Access Criteria
Investigators whose proposed use of the data has been approved by the Principal Investigators of the clinical trial.
More information

Locations