Trial Outcomes & Findings for Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning (NCT NCT03853473)
NCT ID: NCT03853473
Last Updated: 2024-09-19
Results Overview
The investigators will compare the distance study participants can walk in 6 minutes in the pre-surgical period as a measure of frailty.
COMPLETED
NA
17 participants
Pre-Surgery
2024-09-19
Participant Flow
Participants were consented following their clinical appointments. Group assignment did not occur until after pre-testing, which often occurred on a separate day.
Participant milestones
| Measure |
Standard of Care
Study participants will receive standard of care.
|
Remote Ischemic Preconditioning
Study participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery.
Remote Ischemic Preconditioning: Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning
Baseline characteristics by cohort
| Measure |
Standard of Care
n=6 Participants
Study participants will receive standard of care.
|
Remote Ischemic Preconditioning
n=6 Participants
Study participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery.
Remote Ischemic Preconditioning: Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 5 • n=5 Participants
|
71 years
STANDARD_DEVIATION 8 • n=7 Participants
|
74 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-SurgeryThe investigators will compare the distance study participants can walk in 6 minutes in the pre-surgical period as a measure of frailty.
Outcome measures
| Measure |
Standard of Care
n=5 Participants
Study participants will receive standard of care.
|
Remote Ischemic Preconditioning
n=4 Participants
Study participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery.
Remote Ischemic Preconditioning: Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.
|
|---|---|---|
|
6 Minute Walk Test Distance (Pre Surgery)
|
369 Meters
Standard Deviation 60
|
432 Meters
Standard Deviation 42
|
SECONDARY outcome
Timeframe: Pre-SurgeryThe investigators will compare the speed study participants walk over 10 meters in the pre-surgical period as a secondary measure of frailty.
Outcome measures
| Measure |
Standard of Care
n=5 Participants
Study participants will receive standard of care.
|
Remote Ischemic Preconditioning
n=4 Participants
Study participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery.
Remote Ischemic Preconditioning: Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.
|
|---|---|---|
|
10 Meter Walk Test (Pre Surgery)
|
1.12 Meters/Second
Standard Deviation 0.17
|
1.27 Meters/Second
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Years 1-3The investigators will compare the speed study participants stand from a chair, walk three meters, turn around, walk back to the chair, and sit (timed up and go test) in the pre-surgical period as a secondary measure of frailty.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Years 1-3The investigators will compare handgrip strength in the presurgical period as a secondary measure of frailty.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Years 1-3The investigators will compare the distance study participants walk in 6-minutes 4-weeks post-surgery as a secondary outcome of surgical recovery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Years 1-3The investigators will compare the speed study participants walk 10 meters 4-weeks post-surgery as a secondary outcome of surgical recovery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Years 1-3The investigators will compare the speed study participants stand from a chair, walk three meters, turn around, walk back to the chair, and sit (timed up and go test) 4-weeks post surgery as a secondary measure of surgical recovery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Years 1-3The investigators will compare handgrip strength 4-weeks post surgery as a secondary measure of surgical recovery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Years 1-3The investigators will measure the variability of blood pressure during the intraoperative period using the anesthetic record.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Years 1-3The investigators will document the number of hours of physical therapy each study participant participates in following surgery.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Years 1-3The investigators will document any deaths that occur during hospitalization following surgery.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Years 1-3The investigators will document how long participants in both study groups (RIPC or standard of care) stay in the hospital following surgery.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care
Remote Ischemic Preconditioning
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=6 participants at risk
Study participants will receive standard of care.
|
Remote Ischemic Preconditioning
n=6 participants at risk
Study participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery.
Remote Ischemic Preconditioning: Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.
|
|---|---|---|
|
Blood and lymphatic system disorders
Arm turned purple following Ischemic Conditioning
|
0.00%
0/6 • Adverse event data was collected from enrollment to study completion, an average of 6-weeks.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected from enrollment to study completion, an average of 6-weeks.
|
Additional Information
Matthew J. Durand, Ph.D., Principal Investigator
Medical College of Wisconsin
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place