- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03892187
Older Adult Safety in Surgery IV (OASIS) (OASIS)
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?
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- UMass Memorial
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Collaborators
Investigators
- Principal Investigator: Jens M Walz, MD, University of Massachusetts, Worcester
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H00010380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Frail Elderly Syndrome
-
DSM Nutritional Products, Inc.CompletedFrail Elderly | Pre-frail ElderlyNetherlands
-
McMaster UniversityAlberta Health services; Saskatchewan Health Authority - Regina Area; Canadian... and other collaboratorsActive, not recruitingFrail Elderly SyndromeCanada
-
Università degli Studi del Piemonte Orientale "Amedeo...Completed
-
School of Health Sciences GenevaInstitution genevoise de maintien à domicileCompletedFrail Elderly Syndrome
-
University of GlasgowNHS Greater Glasgow and ClydeUnknownFrail Elderly SyndromeUnited Kingdom
-
Castilla-La Mancha Health ServiceColegio Oficial de Terapeutas Ocupacionales de Castilla - La Mancha; Fundación... and other collaboratorsRecruiting
-
Federico II UniversityRecruiting
-
Guang Yang, Prof. Dr.CompletedFrail Elderly SyndromeChina
-
University of Sao PauloCompleted
Clinical Trials on Intervention Group
-
Muğla Sıtkı Koçman UniversityNot yet recruiting
-
University of LiegeCentre Hospitalier Universitaire de Liege; Bial Foundation; FNRS (Télévie); Fondation...RecruitingPain | Cancer | Fatigue | Cognitive Impairment | Sleep Disturbance | Distress, EmotionalBelgium
-
Hospital de Clinicas de Porto AlegreUnknown
-
University of California, San FranciscoNational Cancer Institute (NCI); Cancer Prevention Institute of CaliforniaCompletedHereditary Breast and Ovarian Cancer Syndrome
-
University of Sao PauloCompletedAnxiety | Self Esteem
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases
-
Azienda Ospedaliero-Universitaria CareggiRecruiting
-
University of OxfordOxford Brookes UniversityRecruitingOverweight/Obesity, AdolescentUnited Kingdom
-
Beijing Tsinghua Chang Gung HospitalRecruitingLifestyle Intervention | Non Communicable DiseasesChina