Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001678280p
Ethics application status
Submitted, not yet approved
Date submitted
30/06/2018
Date registered
11/10/2018
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the effects of Bingocize®: A novel and interactive community-based physical activity intervention for older adults.
Scientific title
Exploring the effects of Bingocize®: A novel and interactive community-based physical activity intervention for older adults. Pre and post test for cognitive and functional performance in the elderly
Secondary ID [1] 295344 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 308596 0
Balance 308597 0
Fitness 308598 0
Condition category
Condition code
Public Health 307548 307548 0 0
Other public health
Neurological 307757 307757 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Outcome measures will be administered both before and after the intervention (CG= 12 weeks without an intervention): Pre and post testing of functional performance tests, independence questionnaires, and cognition tests.

The City of Krakow Poland is supporting this project and will help recruit participants from older adult facilities.
After screening, consent and fall risk assessment, the IG will receive x2 Bingocize® sessions per week for 12 weeks an hour each session. Two waves of participants of 25 people will receive the intervention.
A paper version of bingocize will be provided to each individual where each number that is marked throughout the game will allow for participants to either perform a physical activity or answer a health related question. This will be a social group activity conducted by a trained professional in bingocize whom will receive a certificate after completion of the 2 hour training program online. Training includes a website course explaining the rules and instructions.
The CG will be formed separately between the same time period.

Example of Health Questions:

1. People who are moderate to high risk for falling may reduce their risk by
a. Medication management
b. Physical activity
c. Home safety improvements
d. All of the above
A: D

2. Approximately 75% of falls in older adults occur
a. In or near the home
b. At social events
c. While exercising
Answer: A

3. Home safety improvements can
a. Make caregiving more difficult
b. Cause restriction of activities
c. Increase independence and safety
d. Make daily activities more difficult
Answer: C

Examples of Exercises:
Marching in Place for 30 seconds
Chest Press for 30 seconds
Chair stands for 30 seconds
Intervention code [1] 301691 0
Prevention
Comparator / control treatment
100 participants in two separate groups will be needed for this study: 50 in both an intervention group (IG) and a non-intervention control (CG). CG receives no treatment.
Control group
Active

Outcomes
Primary outcome [1] 306527 0
Change in senior fitness test
Timepoint [1] 306527 0
12 weeks post commencement of intervention
Secondary outcome [1] 348784 0
Change in score on Lawton and Brody Instrumental Activities Of Daily Living (IADL) Scale
Timepoint [1] 348784 0
12 weeks post commencement of intervention
Secondary outcome [2] 352013 0
Change in Fall Efficacy Scale
Timepoint [2] 352013 0
12 weeks post commencement of intervention
Secondary outcome [3] 352014 0
Change in COWAT
Timepoint [3] 352014 0
12 weeks post commencement of intervention
Secondary outcome [4] 352015 0
Change in MMSE
Timepoint [4] 352015 0
12 weeks post commencement of intervention
Secondary outcome [5] 352016 0
Change in WHOQOL-BREF
Timepoint [5] 352016 0
12 weeks post commencement of intervention
Secondary outcome [6] 352017 0
Change in Colors Trial Test (CTT)
Timepoint [6] 352017 0
12 weeks post commencement of intervention
Secondary outcome [7] 352018 0
Change in Cognitive Lifetime Activities Questionnaire
Timepoint [7] 352018 0
12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Men and women over the age of 65

Normal or corrected-normal vision

No history of severe neurological impairment, mobility (i.e., not wheel-chair bound)

No structured physical activity (<150 minutes/wk) for past 6 months

Telephone mini-mental status examination (TMMSE) scores >17
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under age of 65
non-ambulatory
below 17 score for TMMSE
No structured physical activity greater than 150 min/wk

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2018
Actual
Date of last participant enrolment
Anticipated
23/10/2018
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10597 0
Poland
State/province [1] 10597 0

Funding & Sponsors
Funding source category [1] 299938 0
University
Name [1] 299938 0
Western Kentucky University
Country [1] 299938 0
United States of America
Primary sponsor type
University
Name
Western Kentucky University
Address
School of Kinesiology, Recreation, and Sport

1906 College Heights Blvd.

Bowling Green, KY. 42101
Country
United States of America
Secondary sponsor category [1] 299342 0
None
Name [1] 299342 0
none
Address [1] 299342 0
Country [1] 299342 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300803 0
Ethics Committee Akademia Wychowania
Ethics committee address [1] 300803 0
Akademia Wychowania Fizycznego we Wroclawiu
51-612 Wroclaw, al. I.J. Paderewskiego 35
Ethics committee country [1] 300803 0
Poland
Date submitted for ethics approval [1] 300803 0
20/04/2018
Approval date [1] 300803 0
Ethics approval number [1] 300803 0

Summary
Brief summary
Bingocize® will be used as an intervention, to improve functional mobility, independence and cognition of older people in the community. Exercise is shown to be an important component of a multi-factorial intervention, particularly when applied consistently for ten weeks or longer. As in previous research concluded by Dr. Crandall et al, it is expected for significant improvement in all three areas (1) aspects of functional (physical) performance, (2) cognition (3) knowledge of age-relevant health topics. The IG will show differential improvements over the control group in all tested areas.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84866 0
Prof Gregorz Zurek
Address 84866 0
Akademia Wychowania Fizycznego we Wroclawiu
51-612 Wroclaw, al. I.J. Paderewskiego 35
Polska
Country 84866 0
Poland
Phone 84866 0
+48 71347 33 66
Fax 84866 0
Email 84866 0
[email protected]
Contact person for public queries
Name 84867 0
Prof Jason Crandall
Address 84867 0
School of Kinesiology, Recreation, and Sport

1906 College Heights Blvd.

Bowling Green, KY. 42101
Country 84867 0
United States of America
Phone 84867 0
+1.270.745.2077
Fax 84867 0
Email 84867 0
[email protected]
Contact person for scientific queries
Name 84868 0
Prof Gregorz Zurek
Address 84868 0
Akademia Wychowania Fizycznego we Wroclawiu
51-612 Wroclaw, al. I.J. Paderewskiego 35
Country 84868 0
Poland
Phone 84868 0
+48 71347 33 66
Fax 84868 0
Email 84868 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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