Jintronix: A New Adaptive Physical Activity Technology in Older Adults

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02467491
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Device: Jintronix	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: A New Adaptive Physical Activity Technology in Older Adults (Jintronix)
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Quality of Movements' Total Average Score [4 weeks]

   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.

2. Total Average Time in Performing Exercises With Jintronix. [4 weeks]

   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.

3. Global Difficulty Score [4 weeks]

   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. Global Appreciation Score [4 weeks]

   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.

Secondary Outcome Measures

1. Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test [Change in baseline to 4 weeks]

   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.

2. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oak Hammock at University of Florida	Gainesville	Florida	United States	32608

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Vincenzo Valiani, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02467491
• Other Study ID Numbers: IRB201500368
• First Posted: Jun 10, 2015
• Last Update Posted: Jun 28, 2016
• Last Verified: May 1, 2016

• Keywords provided by University of Florida: Exercise; Technology; Aging

Study Results

Participant Flow

Pre-assignment Detail	17 participants signed the informed consent, but only 12 participants started and completed the exercise intervention

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	80.5 (4.2)
Sex: Female, Male (Count of Participants)
Female	10 83.3%
Male	2 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	12 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	12 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	22.5 (2.9)
Short Physical Performance Battery score (SPPB) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.2 (1.2)
Rapid Assessment of Physical Activity (RAPA) score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.08 (1.44)
Short Portable Mental Status Questionnaire score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.08 (0.3)

Outcome Measures

1. Primary Outcome

Title	Quality of Movements' Total Average Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Measure Participants	12
Mean (Standard Deviation) [percentage of quality of movements]	87 (10)

2. Primary Outcome

Title	Total Average Time in Performing Exercises With Jintronix.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Measure Participants	12
Mean (Standard Deviation) [minutes]	207.5 (32.51)

3. Primary Outcome

Title	Global Difficulty Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Measure Participants	12
Number [units on a scale]	13

4. Primary Outcome

Title	Global Appreciation Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Measure Participants	12
Number [units on a scale]	33

5. Secondary Outcome

Title	Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	0.67 (0.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Activity Group
	Comments	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-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	0.42 (0.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Activity Group
	Comments	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-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Physical Activity Group
Arm/Group Description	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.
All Cause Mortality
	Physical Activity Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Physical Activity Group
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Physical Activity Group
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.