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

May 19, 2016 updated by: University of Florida

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Oak Hammock at University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks
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 weeks
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
Change in 4 weeks to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vincenzo Valiani, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201500368

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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