Frail Elderly SyndromeOASISNCT03892187
Older Adult Safety in Surgery IV (OASIS)
A study testing Intervention Group in people with Frail Elderly Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Use of remote coaching and walking plan prior to surgery to improve stamina and mobility in frail older adult surgical patients after surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Intervention Group
- Keywords
- prehabilitation, perioperative outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Walking prescriptions plus weekly coaching calls prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Distance
Change from baseline 6MWD to 6MWD on day of discharge
Measured: 21-45 Days
Secondary outcomes (4)
Step counts on Post Op days 1 and 2
Number of steps taken on days one and two post-surgery.
Measured: 2 days
6MWD baseline to presurgical appointment day
Change from baseline 6MWD to 6MWD on day of presurgical appointment
Measured: 3-6 weeks
Baseline to 4 weeks post surgery 6MWD
Change from baseline 6MWD to 6MWD 4 weeks post surgery
Measured: 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
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.
Measured: 7 weeks to 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Mar 2019
- Primary completion6 Nov 2021
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Responsible party
- Principal investigator, J. Matthias Walz, University of Massachusetts, Worcester
- Investigators
- Jens M Walz, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892187
- Sponsor's protocol ID
- H00010380
- Acronym
- OASIS
- Status last verified
- Nov 2023
- First submitted
- 21 Mar 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 33028223
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT03892187
- Acronym / sponsor ID
- OASIS / H00010380
- Conditions
- Frail Elderly Syndrome
- Keywords
- prehabilitation, perioperative outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of remote coaching and walking plan prior to surgery to improve stamina and mobility in frail older adult surgical patients after surgery.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupParticipants 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupWalking prescriptions plus weekly coaching calls prior to surgery. | Behavioural | Intervention Group |
Primary outcome
6 Minute Walk Distance
Time frame: 21-45 Days
Change from baseline 6MWD to 6MWD on day of discharge
4 secondary outcomes
Step counts on Post Op days 1 and 2
Time frame: 2 days
6MWD baseline to presurgical appointment day
Time frame: 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 in The Veterans Rand 12-Item Health Survey (VR12), baseline to 4 wks and 6 months
Time frame: 7 weeks to 27 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 33028223Hoque 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens M Walz, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Frail Elderly Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Distance (time frame: 21-45 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.