AgingJintronixNCT02467491
A New Adaptive Physical Activity Technology in Older Adults
A study testing Jintronix in people with Aging, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Jintronix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oak Hammock at University of Florida
Gainesville, Florida, 32608
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- Jintronix
- Keywords
- Exercise, Technology, Aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Jintronix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Change in 4 weeks to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincenzo Valiani, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467491
- Sponsor's protocol ID
- IRB201500368
- Acronym
- Jintronix
- Status last verified
- May 2016
- First submitted
- 5 Jun 2015
- Last updated
- 28 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Adaptive Physical Activity Technology in Older Adults (Jintronix)
- ClinicalTrials.gov ID
- NCT02467491
- Acronym / sponsor ID
- Jintronix / IRB201500368
- Conditions
- Aging
- Keywords
- Exercise, Technology, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Posted 28 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity group | Other | Device: JintronixAll 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JintronixThe 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. | Device | Physical Activity group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Valiani, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jintronix in people with Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Movements' Total Average Score (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.