Real-time Location System Feasibility Study

NCT03988751 | Completed Results

• 1 other identifier: IRB00039439
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Mobility

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Study Arms (2)

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

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.

Behavioral: Ambulation

Interventions

Ambulation BEHAVIORAL

Variation in ambulatory intensity.

Continuous Ambulation; Interval Ambulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Results Point of Contact

• Title: Dr. Clancy Clark
• Organization: Wake Forest University School of Medicine

cjclark@wakehealth.edu

335-480-8064

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: June 6, 2019
• Primary Completion: June 19, 2019
• Study Completion: August 19, 2022
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)