SurgeryNCT03988751
Real-time Location System Feasibility Study
A study testing Ambulation in people with Surgery and Mobility, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 19 Aug 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between the ages of 18 and 90.
- Admitted to the Surgical Ward.
- Recovering from surgery.
- Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.
- Ability to understand and complete the study survey instruments in English.
Who cannot join
- Non-surgical patient.
- Emergency surgical procedure.
- Anticipated discharge less than 24 hour.
- Unable to ambulate or ambulation not permitted by treating provider.
- Unable to understand and complete the study survey instruments in English.
- Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Real-time Location System Feasibility Study Part 2
The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system.
In this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.
- Being tested
- Ambulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbulationBehavioural
Variation in ambulatory intensity.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Ambulation | Active comparator | The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants Receives: Behavioral: Ambulation |
| Interval Ambulation | Active comparator | The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can. Receives: Behavioral: Ambulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.
Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.
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 posted17 Jun 2019
- Study start6 Jun 2019
- Primary completion19 Jun 2019
- Study completion19 Aug 2022
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 SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988751
- Sponsor's protocol ID
- IRB00039439
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2019
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Location System Feasibility Study Part 2
- ClinicalTrials.gov ID
- NCT03988751
- Acronym / sponsor ID
- IRB00039439
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system.
In this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Ambulation | Active comparator | Behavioral: AmbulationThe total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants |
| Interval Ambulation | Active comparator | Behavioral: AmbulationThe subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients between the ages of 18 and 90.
- Admitted to the Surgical Ward.
- Recovering from surgery.
- Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.
- Ability to understand and complete the study survey instruments in English.
Key exclusion criteria (6 listed)
- Non-surgical patient.
- Emergency surgical procedure.
- Anticipated discharge less than 24 hour.
- Unable to ambulate or ambulation not permitted by treating provider.
- Unable to understand and complete the study survey instruments in English.
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 |
|---|---|---|
| AmbulationVariation in ambulatory intensity. | Behavioural | Continuous Ambulation, Interval Ambulation |
Primary outcome
Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.
Time frame: 1 day
Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery and Mobility, run by Wake Forest University Health Sciences 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 6 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 22 Feb 2024. 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 22 Feb 2024). 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?
Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk. (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 22 Feb 2024.