Mobility, Surgery
Conditions
Brief 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. 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.
Interventions
BEHAVIORALAmbulation
Variation in ambulatory intensity.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk. | 1 day | Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Ambulation The subject will walk a total distance of 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants. | 10 |
| Interval Ambulation 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. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Interval Ambulation | Total | Continuous Ambulation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Continuous | 64 years | 64 years | 65 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: 1 day
Population: Number of participants who completed 40 meter ambulation without adverse event or significant change in vital signs
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Ambulation | Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk. | 10 Participants |
| Interval Ambulation | Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk. | 10 Participants |