A New Adaptive Physical Activity Technology in Older Adults

Aging Clinical Trial

— Jintronix  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467491
• Other study ID #: IRB201500368
• Status: Completed
• Phase: N/A
• First received: June 5, 2015
• Last updated: February 4, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
United States	Oak Hammock at University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of feasibility using the quality of movements for the Jintronix as a new physical activity after 4 weeks	The quality of movements' total average score > 80% that will be automatically calculated by the Jintronix software using their algorithms.	4 weeks	No
Primary	Measure of length of time in performing exercises of the Jintronix as a new physical activity after 4 weeks	The average global time in performing exercises for 12 participants > 192 minutes (3.2 hours) on a total of 240 minutes (4 hours). The total time in performing exercises will be calculated automatically by Jintronix at the end of the program.	4 weeks	No
Primary	Measure of feasibility using the global difficulty score of movements for the Jintronix as a new physical activity after 4 weeks	The global difficulty's score for the all 12 participants < 28 points (80% of the total). This 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 much 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). The sum in points of each participant's answer to this question will make the global difficulty score.	4 weeks	No
Primary	Measure of repeated movements of the Jintronix as a new physical activity after 4 weeks.	The global total number of repeated movements for 12 participants > 80% of the total movements that will be captured by the Jintronix automatically using captors.	4 weeks	No
Primary	Measure of acceptability using the appreciation score of the Jintronix as a new physical activity after 4 weeks	The global appreciation's score for 12 participants > 28 points (80% of the total). 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 sum in points of each participant's answer to this question will make the global appreciation's score.	4 weeks	No
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.	Change in baseline to 4 weeks	No
Secondary	Change from 4 weeks to 3 months 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.	Change in 4 weeks to 3 months	No