N/A
N=17
Piloting Prehabilitation Before Abdominal Surgery
Frailty
Bottom Line
View on ClinicalTrials.gov: NCT03040336 ↗Enrolled (actual)
17
Serious AEs
29.4%
Results posted
Mar 2020
Primary outcome: Primary: Recruitment Rate — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prehabilitation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Rate |
17 | — |
| PRIMARY Randomization Rate |
10; 7 | — |
| PRIMARY Retention Rate |
7; 4 | — |
| PRIMARY Compliance Rate |
56; 10; 93.6 | — |
| SECONDARY Grip Strength |
26.38; 27.75; 29.00; 32.00; 23.75; 33.63 | — |
| SECONDARY Pulmonary Function |
66.00; 79.33; 70.11; 90.00; 63.17; 100.00 | — |
| SECONDARY Serum Prealbumin |
26.5; 29; 22.5; 25.5; 23.6; 22 | — |
| SECONDARY Gait Speed |
0.98; 1.54; 1.00; 1.07; 1.07; 1.21 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
9.13; 10.6; 10.56; 11; 9.8; 10.75 | — |
| SECONDARY Risk Analysis Index of Frailty (RAI)_questionnaire |
31.57; 24.75; 27.86; 29.00; 29.00; 26.67 | — |
| SECONDARY 7-point Subjective Global Assessment of Nutrition_questionnaire |
5.43; 6.4; 5.14; 6.00; 5.14; 6.33 | — |
Summary
Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. We believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, prehabilitation intervention aimed at improving postoperative surgical outcomes through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.
Eligibility Criteria
Inclusion Criteria
- Frail as defined by an Risk Analysis Index (RAI) score >=16
- Scheduled for Major Abdominal Surgery as defined by a procedure that plans to violate the peritoneum or retroperitoneum (excluding inguinal hernias)
Exclusion Criteria
- Unable to participate in planned Prehabilitation regimen
- Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk
- Left ventricular ejection fractions <35%
- Severe valvular heart disease
- Significant arrhythmia
- Cognitive impairments that necessitate surrogate informed consent for the planned surgery
- Unable to speak English
Data sourced from ClinicalTrials.gov (NCT03040336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.