An interventional study of Jintronix in Aging, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by University of Florida · Not applicable and Interventional
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.
A total of 12 older adults will be recruited in the Oak Hammock residential community to participate in a physical activity program using a new technology called Jintronix. 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. The exercises will be performed by each participant autonomously in the living room of the residential community following a specific schedule. The duration of the exercise program will be of 30 minutes for two days a week for a total of four weeks. The participants will be trained prior the beginning of the program in order to enter autonomously in the Jintronix platform and perform the exercises.
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Exclusion Criteria:
All 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.
Device: Jintronix
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test
Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.
Time frame: 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
Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.
Time frame: Change in 4 weeks to 3 months
| Milestone | Physical Activity Group |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| percentage of quality of movements | Physical Activity Group |
|---|---|
| Quality of Movements' Total Average Score | 87 ± 10 |
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.
| minutes | Physical Activity Group |
|---|---|
| Total Average Time in Performing Exercises With Jintronix. | 207.5 ± 32.51 |
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.
| units on a scale | Physical Activity Group |
|---|---|
| Global Difficulty Score | 13 |
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.
| units on a scale | Physical Activity Group |
|---|---|
| Global Appreciation Score | 33 |
Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.
| units on a scale | Physical Activity Group |
|---|---|
| Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test | 0.67 ± 0.98 |
Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.
| units on a scale | Physical Activity Group |
|---|---|
| Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test | 0.42 ± 0.51 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Physical Activity Group | — | 0/12 (0%) | 0/12 (0%) |
Older adults living in the residential community Oak Hammock at University of Florida
| Age, Continuous(years) | Physical Activity Group |
|---|---|
| Mean | 80.5 ± 4.2 |
| Sex: Female, Male(Participants) | Physical Activity Group |
|---|---|
| Female | 10 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Physical Activity Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Physical Activity Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Physical Activity Group |
|---|---|
| United States | 12 |
| Body Mass Index (BMI)(kg/m^2) | Physical Activity Group |
|---|---|
| Mean | 22.5 ± 2.9 |
| Short Physical Performance Battery score (SPPB)(units on a scale) | Physical Activity Group |
|---|---|
| Mean | 8.2 ± 1.2 |
| Rapid Assessment of Physical Activity (RAPA) score(units on a scale) | Physical Activity Group |
|---|---|
| Mean | 4.08 ± 1.44 |
1 further baseline measures are reported on the registry.
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