A New Adaptive Physical Activity Technology in Older Adults
Jintronix
1 other identifier
interventional
17
1 country
1
Brief Summary
The purpose of this study is to explore the feasibility and acceptability of a new physical activity technology (Jintronix) based on TV screen, virtual games and motion sensing cameras among pre-disabled older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
June 28, 2016
CompletedJune 28, 2016
May 1, 2016
5 months
June 5, 2015
February 17, 2016
May 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Quality of Movements' Total Average Score
The quality of movements' score is a measure of feasibility. The quality of movement's score is automatically calculated by Jintronix for each participant at the end of the intervention program with Jintronix. A quality of movement's score of 100% means that the participant performed the exercise perfectly. To calculate the quality of movements' total average score for the Group (made of 12 participants), we summed the quality of movements' score for each participants and divided it for 12. We expected to find a total average quality movements' score\>80% in order to say that Jintronix was feasible.
4 weeks
Total Average Time in Performing Exercises With Jintronix.
Each participant has to perform the exercise program with Jintronix for 30 minutes per session, for 2 times/week for a total of 4 weeks. This means that each participant has to be able to perform a maximum of 240 minutes of exercises for 4 weeks. Jintronix calculated automatically the time (minutes) in performing the exercises for each participant at the end of the 4 weeks of intervention. As a measure of acceptability we calculated the total average time in performing the exercises for the 12 participants for 4 weeks by summing the minutes in performing the exercises for each participants for 4 week and dividing it for 12. We expected to find an average total time in performing the exercises for 12 participants \> 192 minutes (3.2 hours) out of a total of 240 minutes (4 hours) in order to say that Jintronix was acceptable.
4 weeks
Global Difficulty Score
The global difficulty score was another measure of acceptability. The global difficulty score will be derived from each participant's answer to the second question of a 9-item feasibility questionnaire. The second question of the questionnaire is :"How difficult did you find the Jintronix?", participants' answer may be: * Very difficult (3 point) * Quite difficult (2 points) * Not at all (1 points) * No difficulty (0 points). This means that the global difficulty score for 12 participants may range from 0 (no difficult) to 36 (very difficult). We expected to find a global difficulty score \< to 15 in order to say that Jintronix was acceptable.
4 weeks
Global Appreciation Score
The global appreciation score is a measure of feasibility. This score will be derived from each participant's answer to the first question of a 9-item acceptability questionnaire. The second question of the questionnaire is :"How much did you like Jintronix?", participants' answer may be: * I didn't like it (0 point) * A little (1 points) * Moderate (2 points) * A lot (3 points). The global appreciation score is the sum of the points obtained by each participants. The global appreciation score for 12 participants may range from 0 (no appreciation) to 36 (a lot of appreciation). In order to say that Jintronix is feasible we expected a global appreciation score for 12 participant after 4 weeks of intervention to be \> 24.
4 weeks
Secondary Outcomes (2)
Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test
Change in baseline to 4 weeks
Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test
Change in 4 weeks to 3 months
Study Arms (1)
Physical Activity group
OTHERAll the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.
Interventions
The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity.
Eligibility Criteria
You may qualify if:
- Age 75 years and older
- Pre-disabled status evidenced by: 6 ≤ score ≤ 9 on the Short Physical Performance Battery test.
- Willingness to participate in all study procedures.
You may not qualify if:
- Failure to provide informed consent
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Significant cognitive impairment, defined as a known diagnosis of dementia or a short portable mental status questionnaire score \> 2 errors
- Unable to communicate because of severe hearing loss or speech disorder
- Severe visual impairment, which would preclude completion of the assessments and/or exercise program
- Other significant co-morbid diseases that would prevent participation in exercise
- Planning to move out of the area during the study timeframe
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oak Hammock at University of Florida
Gainesville, Florida, 32608, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Vincenzo Valiani
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Vincenzo Valiani, MD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2015
First Posted
June 10, 2015
Study Start
September 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
June 28, 2016
Results First Posted
June 28, 2016
Record last verified: 2016-05