Trial Outcomes & Findings for Piloting Prehabilitation Before Abdominal Surgery (NCT NCT03040336)
NCT ID: NCT03040336
Last Updated: 2020-03-10
Results Overview
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
COMPLETED
NA
17 participants
Baseline
2020-03-10
Participant Flow
Participant milestones
| Measure |
Prehabilitation
Standard of care + Prehabilitation
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
|
Standard of Care
Patient received the standard hospital care
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Prehabilitation
Standard of care + Prehabilitation
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
|
Standard of Care
Patient received the standard hospital care
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Piloting Prehabilitation Before Abdominal Surgery
Baseline characteristics by cohort
| Measure |
Prehabilitation
n=10 Participants
Standard of care + Prehabilitation
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Continuous
|
75.22 years
STANDARD_DEVIATION 7.48 • n=99 Participants
|
71.71 years
STANDARD_DEVIATION 11.08 • n=107 Participants
|
73.69 years
STANDARD_DEVIATION 7.86 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 54 is the number of patients approached. Only 17 were consented and overall analyzed.
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Outcome measures
| Measure |
Approached
n=54 Participants
Patients approached to participate.
|
Standard of Care
Patient received the standard hospital care
|
|---|---|---|
|
Recruitment Rate
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 17 participants were overall analyzed. 10 were randomized to prehab, 7 were randomized to standard of care.
Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions
Outcome measures
| Measure |
Approached
n=17 Participants
Patients approached to participate.
|
Standard of Care
n=17 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Randomization Rate
|
10 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 days postoperativelyRetention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Retention Rate
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day of SurgeryPopulation: The compliance rate is only calculated for the prehabilitation arm.
Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
Patient received the standard hospital care
|
|---|---|---|
|
Compliance Rate
Home exercise log
|
56 percentage of completed activities
Standard Deviation 42.74
|
—
|
|
Compliance Rate
Nutrition log
|
10 percentage of completed activities
Standard Deviation 31.62
|
—
|
|
Compliance Rate
On site exercise sessions
|
93.6 percentage of completed activities
Standard Deviation 7.60
|
—
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the hand grip assessment were analyzed at each completed timepoint.
Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Grip Strength
Baseline
|
26.38 kgf/cm2
Standard Deviation 4.99
|
27.75 kgf/cm2
Standard Deviation 11.19
|
|
Grip Strength
Day of Surgery
|
29.00 kgf/cm2
Standard Deviation 5.38
|
32.00 kgf/cm2
Standard Deviation 13.88
|
|
Grip Strength
90 days
|
23.75 kgf/cm2
Standard Deviation 4.23
|
33.63 kgf/cm2
Standard Deviation 11.28
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Pulmonary Function
Baseline Max MIP
|
66.00 cm of water
Standard Deviation 27.20
|
79.33 cm of water
Standard Deviation 30.81
|
|
Pulmonary Function
Day of Surgery Max MIP
|
70.11 cm of water
Standard Deviation 29.75
|
90.00 cm of water
Standard Deviation 19.97
|
|
Pulmonary Function
90 Day Max MIP
|
63.17 cm of water
Standard Deviation 32.00
|
100.00 cm of water
Standard Deviation 11.53
|
|
Pulmonary Function
Baseline Max MEP
|
90.60 cm of water
Standard Deviation 34.97
|
114.67 cm of water
Standard Deviation 41.56
|
|
Pulmonary Function
Day of Surgery Max MEP
|
108.67 cm of water
Standard Deviation 35.22
|
112.33 cm of water
Standard Deviation 35.64
|
|
Pulmonary Function
90 Day Max MEP
|
97.67 cm of water
Standard Deviation 30.50
|
102.75 cm of water
Standard Deviation 19.48
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the blood draw were analyzed at each completed timepoint. Additionally, there was an error in the lab when processing the blood samples, this caused many samples to be evaluated incorrectly. Only correctly analyzed labs were included in this analysis.
Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.
Outcome measures
| Measure |
Approached
n=9 Participants
Patients approached to participate.
|
Standard of Care
n=4 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Serum Prealbumin
Baseline Prealbumin
|
26.5 mg/dL
Standard Deviation 4.93
|
29 mg/dL
Standard Deviation 2.83
|
|
Serum Prealbumin
Day of Surgery Prealbumin
|
22.5 mg/dL
Standard Deviation 6.36
|
25.5 mg/dL
Standard Deviation 2.12
|
|
Serum Prealbumin
90 Day Prealbumin
|
23.6 mg/dL
Standard Deviation 8.44
|
22 mg/dL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the gait speed assessment were analyzed at each completed timepoint.
Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters.
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Gait Speed
Baseline Gait Speed
|
0.98 m/s
Standard Deviation 0.30
|
1.54 m/s
Standard Deviation 0.55
|
|
Gait Speed
Day of Surgery Gait Speed
|
1.00 m/s
Standard Deviation 0.17
|
1.07 m/s
Standard Deviation 0.15
|
|
Gait Speed
90 Day Gait Speed
|
1.07 m/s
Standard Deviation 0.40
|
1.21 m/s
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the SPPB assessments were analyzed at each completed timepoint.
This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Baseline SPPB
|
9.13 score on a scale
Standard Deviation 2.30
|
10.6 score on a scale
Standard Deviation 1.52
|
|
Short Physical Performance Battery (SPPB)
Day of Surgery SPPB
|
10.56 score on a scale
Standard Deviation 0.88
|
11 score on a scale
Standard Deviation 0
|
|
Short Physical Performance Battery (SPPB)
90 Day SPPB
|
9.8 score on a scale
Standard Deviation 1.79
|
10.75 score on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the RAI assessment were analyzed at each completed timepoint.
This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Risk Analysis Index of Frailty (RAI)_questionnaire
Baseline RAI
|
31.57 score on a scale
Standard Deviation 11.86
|
24.75 score on a scale
Standard Deviation 0.50
|
|
Risk Analysis Index of Frailty (RAI)_questionnaire
Day of Surgery RAI
|
27.86 score on a scale
Standard Deviation 12.79
|
29.00 score on a scale
Standard Deviation 5.66
|
|
Risk Analysis Index of Frailty (RAI)_questionnaire
90 Day RAI
|
29.00 score on a scale
Standard Deviation 10.39
|
26.67 score on a scale
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.
This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.
Outcome measures
| Measure |
Approached
n=10 Participants
Patients approached to participate.
|
Standard of Care
n=7 Participants
Patient received the standard hospital care
|
|---|---|---|
|
7-point Subjective Global Assessment of Nutrition_questionnaire
Baseline Subjective Global Assessment
|
5.43 score on a scale
Standard Deviation 0.79
|
6.4 score on a scale
Standard Deviation 0.55
|
|
7-point Subjective Global Assessment of Nutrition_questionnaire
Day of Surgery Subjective Global Assessment
|
5.14 score on a scale
Standard Deviation 1.07
|
6.00 score on a scale
Standard Deviation 0
|
|
7-point Subjective Global Assessment of Nutrition_questionnaire
90 Day Subjective Global Assessment
|
5.14 score on a scale
Standard Deviation 1.07
|
6.33 score on a scale
Standard Deviation 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 and 90 days postoperativelyPopulation: The mortality questionnaire was completed for all participants still enrolled in the study at the indicated time point.
Postoperative mortality
Outcome measures
| Measure |
Approached
n=9 Participants
Patients approached to participate.
|
Standard of Care
n=4 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Postoperative Mortality
30-days mortality
|
0 Participants
|
0 Participants
|
|
Postoperative Mortality
90-days mortality
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, day of surgery, 90-days postoperativelyPopulation: Not all participants were analyzed, because this measure requires participants to complete the questionnaire and not all participants did.
Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Approached
n=7 Participants
Patients approached to participate.
|
Standard of Care
n=3 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Health Related Quality of Life
Baseline
|
0.72 score on a scale
Standard Deviation 0.09
|
0.67 score on a scale
Standard Deviation 0.05
|
|
Health Related Quality of Life
Day of Surgery
|
0.68 score on a scale
Standard Deviation 0.08
|
0.77 score on a scale
Standard Deviation 0.01
|
|
Health Related Quality of Life
90-days postoperative
|
0.75 score on a scale
Standard Deviation 0.09
|
0.80 score on a scale
Standard Deviation 0.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of Surgery and 30-days postoperativelyPopulation: All participants that completed the assessment were analyzed at each completed timepoint.
AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.
Outcome measures
| Measure |
Approached
n=9 Participants
Patients approached to participate.
|
Standard of Care
n=5 Participants
Patient received the standard hospital care
|
|---|---|---|
|
Quality of Surgical Care
Day of Surgery Total Communication
|
1.33 score on a scale
Standard Deviation 0.37
|
1.13 score on a scale
Standard Deviation 0.18
|
|
Quality of Surgical Care
30-days Total Communication
|
1.25 score on a scale
Standard Deviation 0.29
|
1.19 score on a scale
Standard Deviation 0.24
|
Adverse Events
Prehabilitation
Standard of Care
Serious adverse events
| Measure |
Prehabilitation
n=10 participants at risk
Standard of care + Prehabilitation
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
|
Standard of Care
n=7 participants at risk
Patient received the standard hospital care
|
|---|---|---|
|
Injury, poisoning and procedural complications
Unexpected and unrelated hospitalization
|
30.0%
3/10 • Number of events 6 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
|
Respiratory, thoracic and mediastinal disorders
Unexpected and unrelated death
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
0.00%
0/7 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place