Older Adult Safety in Surgery IV (OASIS) (OASIS)

November 11, 2023 updated by: J. Matthias Walz, University of Massachusetts, Worcester

Older Adult Safety in Surgery (OASIS) - Can a Preoperative Self-Reported Functional Status Information Improve Prediction of Cardiac Mobility Related Complications That Threaten Patient Safety In Older Adult Surgical Patients?

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

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Surgery is a life-saving procedure for patients with cancer and can enhance quality of life for patients with intractable abdominal, urologic, thoracic, or other major disease. Although most patients tolerate the procedure well, frail older adults have as much as a threefold increase in the risk of adverse outcomes after surgery. The proposal will assess the role of a walking intervention in the surgical context over multiple dimensions of physical status-endurance, balance, gait speed, strength, and self-reported function. The investigators will be collecting data on patients who may be undergoing any abdominal, urologic, thoracic, or other major surgery.

The investigators will be introducing a home walking prescription where subjects will self-monitor the amount of walking with use of a fit-bit type wristband pedometer. Via remote coaching and use of the pedometer, the investigators hope to increase the amount of steps over a period of time prior to surgery. A research grade monitor will then be utilized in order to be able to track steps post surgery during the hospital stay. By increasing movement pre and post surgery, the investigators hope to demonstrate that such a program can reduce the incidence of adverse outcomes or improve physical status assessments such as endurance, balance, gait speed, strength, and self-reported function. Patients will be randomized in a 1:1 fashion into intervention and control groups using a prespecified table generated by our study statistician.

Intervention patients will receive a walking prescription and weekly calls from a study staff member. Patients will be given a pedometer to be worn on their wrist, a phone , and a phone charger. Patients will be instructed to synchronize their pedometer to the provided phone once a day. For three days following the baseline visit, patients will be instructed to walk their usual amount. A study staff member will then provide the initial walking prescription based on the participants' baseline performance on the three of baseline walking and will focus the participant on walking at a moderate intensity (level of approximately 3 on the modified Borg Perceived Exertional Scale;14 laminated Borg scales will be distributed to participants).

Participants may walk steps over the course of a day or in one session. The initial walking prescription will also provide instructions to the participant to increase his/her number of steps each week by 10 to 20%.

Study Visits for intervention subjects. Baseline visit (consent)- If agree to participate in the study this group will receive weekly phone calls from a study staff member until the surgery. Following the baseline visit, subjects will also be seen during their preoperative surgical evaluation visit, on the day of their surgery, on approximately the third or fourth day following the surgery or date of discharge if length of stay is less than three days, at approximately 30 days following surgery and a phone call approximately 6 months following the surgery.

Study visits for control frail and control non-frail subjects Baseline visit (consent)- If agree to participate in the study a study staff member will provide general walking advice with typical warnings about when to stop (e.g., chest pain, breathing difficulty, or fall) and will have a follow up phone call approximately 6 months following the surgery. Control subjects will receive no other intervention.

Both groups will be asked to complete a log of their physical activities. Patient data collection will continue for up to one year after the day of surgery.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria for screening:

  • Non-adults
  • Prisoners
  • Non-English language speaker for whom short form consent is not available

Exclusion criteria for randomized controlled trial:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
Walking prescriptions plus weekly coaching calls prior to surgery.
No Intervention: Control Group
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.
No Intervention: Observation Group
Participants who are not frail will receive usual care prior to surgery and charts will be reviewed for outcomes following surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute Walk Distance
Time Frame: 21-45 Days
Change from baseline 6MWD to 6MWD on day of discharge
21-45 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step counts on Post Op days 1 and 2
Time Frame: 2 days
Number of steps taken on days one and two post-surgery.
2 days
6MWD baseline to presurgical appointment day
Time Frame: 3-6 weeks
Change from baseline 6MWD to 6MWD on day of presurgical appointment
3-6 weeks
Baseline to 4 weeks post surgery 6MWD
Time Frame: 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 from baseline 6MWD to 6MWD 4 weeks post surgery
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
Time Frame: 7 weeks to 27 weeks
Change in score on VR12 assessment at baseline as compared to 4 weeks post surgery and 6 months post surgery. The The Veterans Rand 12-Item Health Survey (VR12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. Question 1 is on a five point scale, questions 2a and 2b are on a 3 point scale; questions 3 through 5 are on a five point scale, questions 6a -6c are on a six point scale, questions 7 through 9 are on a five point scale. A total score is calculated, with a lower score meaning a more positive perspective of health. We will calculate the total score of the VR12 and then calculate the summary physical component score (PCS) based off of the V12 score, using a published algorithm.16 The algorithm norms PCS to range between 0 and 100, with 50 as a mean, and 10 as the standard deviation for the US population.
7 weeks to 27 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jens M Walz, MD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

November 6, 2021

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • H00010380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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