Older Adult Safety in Surgery IV (OASIS)

NCT03892187 | Completed

• 1 other identifier: H00010380
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Use of remote coaching and walking plan prior to surgery to improve stamina and mobility in frail older adult surgical patients after surgery.

Conditions

Frail Elderly Syndrome

Keywords

prehabilitation; perioperative outcomes

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Distance

  Change from baseline 6MWD to 6MWD on day of discharge

  21-45 Days

Secondary Outcomes (4)

• Step counts on Post Op days 1 and 2

  2 days

• 6MWD baseline to presurgical appointment day

  3-6 weeks

• Baseline to 4 weeks post surgery 6MWD

  7-10 weeks (Baseline can be anywhere between 3 to 6 weeks pre-surgery, therefore 4 weeks post surgery can be anywhere from 7 weeks after baseline to 10 weeks after baseline)

• Change in The Veterans Rand 12-Item Health Survey (VR12), baseline to 4 wks and 6 months

  7 weeks to 27 weeks

Study Arms (3)

Intervention Group

EXPERIMENTAL

Participants are prescribed a walking prescription based on their baseline daily step count. During the interim between the day of consultation until the day of surgery, a study staff member will make weekly calls to each participant. Participants will also log all of their physical activities including the date, activity type, and number of minutes.

Behavioral: Intervention Group

Control Group

NO INTERVENTION

Participants receive usual care prior to surgery. Participants will also log all of their physical activities including the date, activity type, and number of minutes.

Observation Group

NO INTERVENTION

Participants who are not frail will receive usual care prior to surgery and charts will be reviewed for outcomes following surgery.

Interventions

Intervention Group BEHAVIORAL

Walking prescriptions plus weekly coaching calls prior to surgery.

Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 and older
• Undergoing any abdominal, thoracic, urologic, or other major surgery
• Independently ambulatory
• Patient should be within 3-8 weeks of surgery
• Estimated length of hospital stay after surgery two days or more

You may not qualify if:

• Non-adults
• Prisoners
• Non-English language speaker for whom short form consent is not available
• Unstable angina or stable angina with minimal exertion or at rest
• Visual impairment such that walking impairs safety
• Fall within previous three months
• Resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, or a diastolic blood pressure of more than 100 mm Hg
• Patient who does not walk independently (e.g. wheel chair; cane walking is okay)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Anesthesia Patient Safety Foundation: collaborator

Study Sites (1)

UMass Memorial

Worcester, Massachusetts, 01605, United States

Location

Related Publications (1)

• Hoque L, Dewolf R, Meyers D, White DK, Mazor KM, Stefan M, Crawford S, Alavi K, Yates J, Maxfield M, Lou F, Uy K, Walz M, Kapoor A. Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol. BMC Geriatr. 2020 Oct 7;20(1):394. doi: 10.1186/s12877-020-01799-y.

  PMID: 33028223 DERIVED

Study Officials

• Jens M Walz, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Anesthesiology & Perioperative Medicine

Model Details: We will randomize patients in a 1:1 fashion into intervention and control groups using a prespecified table generated by our study statistician. Patients not considered frail

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: March 1, 2019
• Primary Completion: November 6, 2021
• Study Completion: June 1, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)