NCT02467491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

June 5, 2015

Results QC Date

February 17, 2016

Last Update Submit

May 19, 2016

Conditions

Keywords

ExerciseTechnologyAging

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    4 weeks

Secondary Outcomes (2)

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

    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

    Change in 4 weeks to 3 months

Study Arms (1)

Physical Activity group

OTHER

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

Interventions

JintronixDEVICE

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.

Physical Activity group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oak Hammock at University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Vincenzo Valiani
Organization
University of Florida

Study Officials

  • Vincenzo Valiani, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 10, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 28, 2016

Results First Posted

June 28, 2016

Record last verified: 2016-05

Locations