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Completed

NCT Number: NCT02467491

A New Adaptive Physical Activity Technology in Older Adults

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.

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Key information

Conditions

Aging Behavior Motor Activity

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oak Hammock at University of Florida

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jintronix

Device

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.

Primary outcomes

  1. Quality of Movements' Total Average Score

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: Jintronix

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2015
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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