Physical MedicineNCT03595605
Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition
A study testing Ambulation in people with Physical Medicine, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and… Read more about this study
- Who is it for?
- Ages 66 to 100 years
- Conditions the study is for
- Physical Medicine
- What is being tested?
- Ambulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2018to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 66 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Admitted to acute inpatient medicine unit
- Ambulatory without assistive device prior to hospitalization
- Medical clearance to ambulate on the unit
- Active MyChart account or willing to activate MyChart account
- iOS or Android device
Who cannot join
- Patients less than or equal to 65 years old
- Not Admitted to acute inpatient medicine unit
- Ambulatory with assistive device prior to hospitalization
- No Medical clearance to ambulate on the unit
- Inactive MyChart account and not willing to activate MyChart account
- No iOS or Android device
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- In addition, an individual who meets any of the following criteria will be excluded from participation in this study:
- Oxygen requirement at rest
- Lower extremity prosthesis
- Admitted for joint replacement surgery
- History of frequent falls
- Admitted for syncope.
- If patients have specifically opted out of being contacted about research (visible in the Epic header while in their chart)
- Admitted from nursing home
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and pre-hospital ambulatory status. While both groups will be monitored in terms of their activity (specifically pedometer data), the intervention group will have twice daily encouragement of ambulation. Once a subject is enrolled, data will be collected daily and at time of discharge.
- Conditions
- Physical Medicine
- Being tested
- Ambulation, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbulationBehavioural
This group will be encouraged twice daily to ambulate
Standard of CareOther
Care as usual at inpatient NYU Langone
| Study group | Role | What they receive |
|---|---|---|
| FitBit Group | Experimental | Will receive a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay. They will receive nudges twice/day to ambulate Receives: Behavioral: Ambulation |
| Control Group-Standard of Care | Active comparator | 300 subjects who will receive usual standard of care on a general inpatient medicine unit with the addition of a wearable device (FitBit) to track usual mobility in this setting. will complete their admission without push for increased activity (although having the device may influence their steps taken). Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine how many steps patients admitted to the medicine units are taking at baseline
Steps will be measured using a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start16 May 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical MedicineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gavriil Ilizarov, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595605
- Sponsor's protocol ID
- 17-01792
- Status last verified
- May 2020
- First submitted
- 22 May 2018
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition
- ClinicalTrials.gov ID
- NCT03595605
- Acronym / sponsor ID
- 17-01792
- Conditions
- Physical Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and pre-hospital ambulatory status. While both groups will be monitored in terms of their activity (specifically pedometer data), the intervention group will have twice daily encouragement of ambulation. Once a subject is enrolled, data will be collected daily and at time of discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FitBit Group | Experimental | Behavioral: AmbulationWill receive a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay. They will receive nudges twice/day to ambulate |
| Control Group-Standard of Care | Active comparator | Other: Standard of Care300 subjects who will receive usual standard of care on a general inpatient medicine unit with the addition of a wearable device (FitBit) to track usual mobility in this setting. will complete their admission without push for increased activity (although having the device may influence their steps taken). |
Who may qualify
- Ages
- 66 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Admitted to acute inpatient medicine unit
- Ambulatory without assistive device prior to hospitalization
- Medical clearance to ambulate on the unit
- Active MyChart account or willing to activate MyChart account
- iOS or Android device
Key exclusion criteria (14 listed)
- Patients less than or equal to 65 years old
- Not Admitted to acute inpatient medicine unit
- Ambulatory with assistive device prior to hospitalization
- No Medical clearance to ambulate on the unit
- Inactive MyChart account and not willing to activate MyChart account
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 |
|---|---|---|
| AmbulationThis group will be encouraged twice daily to ambulate | Behavioural | FitBit Group |
| Standard of CareCare as usual at inpatient NYU Langone | Other | Control Group-Standard of Care |
Primary outcome
Determine how many steps patients admitted to the medicine units are taking at baseline
Time frame: 1 Day
Steps will be measured using a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
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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.
Gavriil Ilizarov principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulation in people with Physical Medicine, run by NYU Langone Health 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 5 inclusion and 14 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 29 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine how many steps patients admitted to the medicine units are taking at baseline (time frame: 1 Day). 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 29 May 2020.