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A New Adaptive Physical Activity Technology in Older Adults

A New Adaptive Physical Activity Technology in Older Adults (Jintronix)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02467491
Acronym
Jintronix
Enrollment
17
Registered
2015-06-10
Start date
2015-09-30
Completion date
2016-02-29
Last updated
2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Exercise, Technology, Aging

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.

Detailed description

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.

Interventions

DEVICEJintronix

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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Movements' Total Average Score4 weeksThe 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.
Total Average Time in Performing Exercises With Jintronix.4 weeksEach 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.
Global Difficulty Score4 weeksThe 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.
Global Appreciation Score4 weeksThe 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.

Secondary

MeasureTime frameDescription
Change From Baseline to 4 Weeks in the Short Physical Performance Battery TestChange in baseline to 4 weeksPhysical 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.
Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery TestChange in 4 weeks to 3 monthsPhysical 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.

Countries

United States

Participant flow

Pre-assignment details

17 participants signed the informed consent, but only 12 participants started and completed the exercise intervention

Participants by arm

ArmCount
Physical Activity Group
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. 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.
12
Total12

Baseline characteristics

CharacteristicPhysical Activity Group
Age, Continuous80.5 years
STANDARD_DEVIATION 4.2
Body Mass Index (BMI)22.5 kg/m^2
STANDARD_DEVIATION 2.9
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
12 Participants
Rapid Assessment of Physical Activity (RAPA) score4.08 units on a scale
STANDARD_DEVIATION 1.44
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
2 Participants
Short Physical Performance Battery score (SPPB)8.2 units on a scale
STANDARD_DEVIATION 1.2
Short Portable Mental Status Questionnaire score0.08 units on a scale
STANDARD_DEVIATION 0.3

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

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

ArmMeasureValue (NUMBER)
Physical Activity GroupGlobal Appreciation Score33 units on a scale
Primary

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

ArmMeasureValue (NUMBER)
Physical Activity GroupGlobal Difficulty Score13 units on a scale
Primary

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

ArmMeasureValue (MEAN)Dispersion
Physical Activity GroupQuality of Movements' Total Average Score87 percentage of quality of movementsStandard Deviation 10
Primary

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

ArmMeasureValue (MEAN)Dispersion
Physical Activity GroupTotal Average Time in Performing Exercises With Jintronix.207.5 minutesStandard Deviation 32.51
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Physical Activity GroupChange From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test0.42 units on a scaleStandard Deviation 0.51
Comparison: The Short Physical Performance Battery (SPPB) score after 4 weeks of physical activity intervention was compared with the SPPB score after 2 to 3 months from the completion of the physical activity intervention with a paired t-testp-value: 0.02t-test, 2 sided
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Physical Activity GroupChange From Baseline to 4 Weeks in the Short Physical Performance Battery Test0.67 units on a scaleStandard Deviation 0.98
Comparison: The Short Physical Performance Battery (SPPB) score at baseline was compared with the SPPB scored after 4 weeks of physical activity intervention with a paired t-testp-value: 0.04t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026