Physical ActivityNCT02528669
Patient Ambulation in Post-Op Recovery
A study testing RX Navigait in people with Physical Activity, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to create a platform that accurately measures and reports patient physical activity before a procedure, during the hospital stay, and after discharge from the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- RX Navigait
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2014to 10 Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of physician study investigators
Who cannot join
- Patients whose physicians find they are unfit to participate in a walking program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Patient Ambulation in Post-Operative Recovery
The purpose of this study is to create a platform that accurately measures and reports patient physical activity before a procedure, during the hospital stay, and after discharge from the hospital.
Read the detailed description
Early ambulation in post-operative patients has shown benefits including shorter length of stay and/or fewer complications. Accelerometers have been found as useful instruments in encouraging ambulation in patients. Accelerometers are non-invasive devices that can evaluate changes in movement, gait, and ambulatory activity. Although these devices can be beneficial, little research exists on the best way to engage patients in ambulation, how to develop a standard ambulation protocol, and the best algorithms to measure ambulation post-operation. This study seeks to develop a standardized activity tracker and program that will encourage patient ambulation and allow patients and healthcare providers to view the progress of daily walking goals.
A total of 3,000 patients will be asked if they would like to participate in this study. A healthcare provider will explain to the patient the benefits of getting out of bed, sitting, and walking after an invasive procedure. Patients who decide to participate will be given an accelerometer during their pre-operation visit or after their surgery while still in the hospital. Patients will be asked to wear the accelerometer continuously during waking hours. The accelerometer will provide patients with daily walking goals, reminders of when it is time to walk, track step count, record time of walk, and duration of walk. Patients will be asked to wear the accelerometer until their post-op visit (about 30 days).
The following data points will be analyzed:
- Relationship between ambulation and patient outcomes
- Relationship between ambulation and other health factors
- Effectiveness of prototype platform to motivate and monitor patient activity
- Conditions
- Physical Activity
- Being tested
- RX Navigait
- Keywords
- accelerometer, patient ambulation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX NavigaitDevice
The RX Navigait is an accelerometer that tracks the number to steps taken, duration of walking, and time of walking. In addition, this device sends messages to patients regarding daily walking goals and walking reminders.
| Study group | Role | What they receive |
|---|---|---|
| RX Navigait | Experimental | Individuals in this group will be given an activity tracking device that receives and displays walking reminders and daily walking goals. In addition, they will be given additional education about the benefits of walking. The device will track daily steps taken, minutes of walking, and frequency of walking bouts throughout the day. Receives: Device: RX Navigait |
| Control Group | No intervention | Participants in this group will be given an activity tracking device that receives and displays walking reminders and daily walking goals but will not receive additional education regarding the benefits of walking. The device will track daily steps taken, minutes of walking, and frequency of walking bouts throughout the day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Ambulation (number of steps, frequency, time)
Measured: Up to 3 months
Secondary outcomes (2)
Accuracy of accelerometer algorithms measuring post operation walking
Measured: Up to three years
Number of patients completing ambulation program
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start23 Jul 2014
- Primary completion10 Oct 2016
- Study completion10 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Savvysherpa, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Ott, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528669
- Sponsor's protocol ID
- 1024875
- Status last verified
- May 2015
- First submitted
- 31 Jul 2015
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Patient Ambulation in Post-Operative Recovery
- ClinicalTrials.gov ID
- NCT02528669
- Acronym / sponsor ID
- 1024875
- Conditions
- Physical Activity
- Keywords
- accelerometer, patient ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Savvysherpa, Inc.
- Study start
- 23 Jul 2014 (actual)
- Primary completion
- 10 Oct 2016 (actual)
- Study completion
- 10 Oct 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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.
The purpose of this study is to create a platform that accurately measures and reports patient physical activity before a procedure, during the hospital stay, and after discharge from the hospital.
Detailed description
Early ambulation in post-operative patients has shown benefits including shorter length of stay and/or fewer complications. Accelerometers have been found as useful instruments in encouraging ambulation in patients. Accelerometers are non-invasive devices that can evaluate changes in movement, gait, and ambulatory activity. Although these devices can be beneficial, little research exists on the best way to engage patients in ambulation, how to develop a standard ambulation protocol, and the best algorithms to measure ambulation post-operation. This study seeks to develop a standardized activity tracker and program that will encourage patient ambulation and allow patients and healthcare providers to view the progress of daily walking goals.
A total of 3,000 patients will be asked if they would like to participate in this study. A healthcare provider will explain to the patient the benefits of getting out of bed, sitting, and walking after an invasive procedure. Patients who decide to participate will be given an accelerometer during their pre-operation visit or after their surgery while still in the hospital. Patients will be asked to wear the accelerometer continuously during waking hours. The accelerometer will provide patients with daily walking goals, reminders of when it is time to walk, track step count, record time of walk, and duration of walk. Patients will be asked to wear the accelerometer until their post-op visit (about 30 days).
The following data points will be analyzed:
- Relationship between ambulation and patient outcomes
- Relationship between ambulation and other health factors
- Effectiveness of prototype platform to motivate and monitor patient activity
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RX Navigait | Experimental | Device: RX NavigaitIndividuals in this group will be given an activity tracking device that receives and displays walking reminders and daily walking goals. In addition, they will be given additional education about the benefits of walking. The device will track daily steps taken, minutes of walking, and frequency of walking bouts throughout the day. |
| Control Group | No intervention | –Participants in this group will be given an activity tracking device that receives and displays walking reminders and daily walking goals but will not receive additional education regarding the benefits of walking. The device will track daily steps taken, minutes of walking, and frequency of walking bouts throughout the day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of physician study investigators
Key exclusion criteria (1 listed)
- Patients whose physicians find they are unfit to participate in a walking 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 |
|---|---|---|
| RX NavigaitThe RX Navigait is an accelerometer that tracks the number to steps taken, duration of walking, and time of walking. In addition, this device sends messages to patients regarding daily walking goals and walking reminders. | Device | RX Navigait |
Primary outcome
Patient Ambulation (number of steps, frequency, time)
Time frame: Up to 3 months
2 secondary outcomes
Accuracy of accelerometer algorithms measuring post operation walking
Time frame: Up to three years
Number of patients completing ambulation program
Time frame: Up to three years
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 17 Oct 2017.
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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.
Mark Ott, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RX Navigait in people with Physical Activity, run by Intermountain Health Care, Inc. 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 1 inclusion and 1 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 17 Oct 2017. 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?
Patient Ambulation (number of steps, frequency, time) (time frame: Up to 3 months). 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 17 Oct 2017.