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Piloting Prehabilitation Before Abdominal Surgery

Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03040336
Enrollment
17
Registered
2017-02-02
Start date
2017-02-01
Completion date
2018-12-28
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Keywords

surgery, prehabilitation, exercise therapy, nutrition support

Brief 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.

Detailed description

Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgeons operate safely on even the oldest old, if the elder is also frail, the stress of surgery can result in significant mortality, morbidity, and institutionalization. Frailty is a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age, and is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older and more frail, it is critically important to identify effective strategies for improving the surgical outcomes of these patients. Prehabilitation has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength, improving nutrition, and optimizing home supports. Based on this success, there is growing interest in deploying similar interventions before surgery in what some call prehabilitation. By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of both surgery and recovery. Frail patients will likely benefit disproportionately from prehabilitation because they have the most diminished capacity to adapt to the stress of surgery. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations. Objectives: We will examine the feasibility of a novel, multifaceted pre-habilitation intervention aimed at improving postoperative outcomes for frail Veterans undergoing major abdominal surgery. Specific aims are to: 1. Estimate rates of recruitment, randomization, retention, and compliance with the prehabilitation intervention; 2. Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline and 2-week intervals to estimate changes over time and explore the optimal duration of prehabilitation (2 vs. 4 vs. 6 weeks); and 3. Estimate overall and treatment-specific summary statistics for postoperative outcomes in terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change in level of independent living. Methods: This randomized pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major abdominal surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System. We will randomize participants 1:1 to receive either: (1) standard preoperative optimization by the Interdisciplinary Medical Preoperative Assessment Consultation & Treatment Clinic (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation. Assessments will include standard postoperative outcomes as well as the Short Physical Performance Battery to measure physical performance, Maximal Inspiratory Pressure to measure pulmonary function, and both prealbumin and the 7-point Subjective Global Assessment to measure nutrition. Outcomes will be assessed 30 or 90 days after surgery. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform the development of a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the as many as 42,000 frail Veterans scheduled for major elective surgery each year.

Interventions

BEHAVIORALPrehabilitation

The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment RateBaselineRecruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Randomization RateBaselineRandomization 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
Retention RateBaseline 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.
Compliance RateBaseline to Day of SurgeryCompliance 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.

Secondary

MeasureTime frameDescription
7-point Subjective Global Assessment of Nutrition_questionnaireBaseline, day of surgery, 90 days postoperativelyThis 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.
Gait SpeedBaseline, day of surgery, 90 days postoperativelyGait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters.
Short Physical Performance Battery (SPPB)Baseline, day of surgery, 90 days postoperativelyThis 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.
Risk Analysis Index of Frailty (RAI)_questionnaireBaseline, day of surgery, 90 days postoperativelyThis 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.
Grip StrengthBaseline, day of surgery, 90 days postoperativelyGrip strength will be measured in kilograms of pressure using a Jamar grip dynamometer
Pulmonary FunctionBaseline, day of surgery, 90 days postoperativelyPulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.
Serum PrealbuminBaseline, day of surgery, 90 days postoperativelyNutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.

Other

MeasureTime frameDescription
Health Related Quality of LifeBaseline, day of surgery, 90-days postoperativelyAssessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.
Quality of Surgical CareDay of Surgery and 30-days postoperativelyAHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.
Postoperative Mortality30 and 90 days postoperativelyPostoperative mortality

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
10
Standard of Care
Patient received the standard hospital care
7
Total17

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath10
Overall StudyWithdrawal by Subject23

Baseline characteristics

CharacteristicPrehabilitationStandard of CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants6 Participants15 Participants
Age, Categorical
Between 18 and 65 years
1 Participants1 Participants2 Participants
Age, Continuous75.22 years
STANDARD_DEVIATION 7.48
71.71 years
STANDARD_DEVIATION 11.08
73.69 years
STANDARD_DEVIATION 7.86
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants7 Participants17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants5 Participants13 Participants
Region of Enrollment
United States
10 Participants7 Participants17 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
10 Participants7 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 100 / 7
other
Total, other adverse events
0 / 100 / 7
serious
Total, serious adverse events
3 / 102 / 7

Outcome results

Primary

Compliance Rate

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.

Time frame: Baseline to Day of Surgery

Population: The compliance rate is only calculated for the prehabilitation arm.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedCompliance RateHome exercise log56 percentage of completed activitiesStandard Deviation 42.74
ApproachedCompliance RateNutrition log10 percentage of completed activitiesStandard Deviation 31.62
ApproachedCompliance RateOn site exercise sessions93.6 percentage of completed activitiesStandard Deviation 7.6
Primary

Randomization Rate

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

Time frame: Baseline

Population: 17 participants were overall analyzed. 10 were randomized to prehab, 7 were randomized to standard of care.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ApproachedRandomization Rate10 Participants
Standard of CareRandomization Rate7 Participants
Primary

Recruitment Rate

Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.

Time frame: Baseline

Population: 54 is the number of patients approached. Only 17 were consented and overall analyzed.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ApproachedRecruitment Rate17 Participants
Primary

Retention Rate

Retention 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.

Time frame: Baseline to 90 days postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ApproachedRetention Rate7 Participants
Standard of CareRetention Rate4 Participants
Secondary

7-point Subjective Global Assessment of Nutrition_questionnaire

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.

Time frame: Baseline, day of surgery, 90 days postoperatively

Population: All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Approached7-point Subjective Global Assessment of Nutrition_questionnaireBaseline Subjective Global Assessment5.43 score on a scaleStandard Deviation 0.79
Approached7-point Subjective Global Assessment of Nutrition_questionnaireDay of Surgery Subjective Global Assessment5.14 score on a scaleStandard Deviation 1.07
Approached7-point Subjective Global Assessment of Nutrition_questionnaire90 Day Subjective Global Assessment5.14 score on a scaleStandard Deviation 1.07
Standard of Care7-point Subjective Global Assessment of Nutrition_questionnaireBaseline Subjective Global Assessment6.4 score on a scaleStandard Deviation 0.55
Standard of Care7-point Subjective Global Assessment of Nutrition_questionnaireDay of Surgery Subjective Global Assessment6.00 score on a scaleStandard Deviation 0
Standard of Care7-point Subjective Global Assessment of Nutrition_questionnaire90 Day Subjective Global Assessment6.33 score on a scaleStandard Deviation 0.58
Secondary

Gait Speed

Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters.

Time frame: Baseline, day of surgery, 90 days postoperatively

Population: All participants that completed the gait speed assessment were analyzed at each completed timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedGait SpeedBaseline Gait Speed0.98 m/sStandard Deviation 0.3
ApproachedGait SpeedDay of Surgery Gait Speed1.00 m/sStandard Deviation 0.17
ApproachedGait Speed90 Day Gait Speed1.07 m/sStandard Deviation 0.4
Standard of CareGait SpeedBaseline Gait Speed1.54 m/sStandard Deviation 0.55
Standard of CareGait SpeedDay of Surgery Gait Speed1.07 m/sStandard Deviation 0.15
Standard of CareGait Speed90 Day Gait Speed1.21 m/sStandard Deviation 0.2
Secondary

Grip Strength

Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer

Time frame: Baseline, day of surgery, 90 days postoperatively

Population: All participants that completed the hand grip assessment were analyzed at each completed timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedGrip StrengthBaseline26.38 kgf/cm2Standard Deviation 4.99
ApproachedGrip StrengthDay of Surgery29.00 kgf/cm2Standard Deviation 5.38
ApproachedGrip Strength90 days23.75 kgf/cm2Standard Deviation 4.23
Standard of CareGrip StrengthBaseline27.75 kgf/cm2Standard Deviation 11.19
Standard of CareGrip StrengthDay of Surgery32.00 kgf/cm2Standard Deviation 13.88
Standard of CareGrip Strength90 days33.63 kgf/cm2Standard Deviation 11.28
Secondary

Pulmonary Function

Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.

Time frame: Baseline, day of surgery, 90 days postoperatively

Population: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedPulmonary FunctionBaseline Max MIP66.00 cm of waterStandard Deviation 27.2
ApproachedPulmonary FunctionDay of Surgery Max MIP70.11 cm of waterStandard Deviation 29.75
ApproachedPulmonary Function90 Day Max MIP63.17 cm of waterStandard Deviation 32
ApproachedPulmonary FunctionBaseline Max MEP90.60 cm of waterStandard Deviation 34.97
ApproachedPulmonary FunctionDay of Surgery Max MEP108.67 cm of waterStandard Deviation 35.22
ApproachedPulmonary Function90 Day Max MEP97.67 cm of waterStandard Deviation 30.5
Standard of CarePulmonary FunctionDay of Surgery Max MEP112.33 cm of waterStandard Deviation 35.64
Standard of CarePulmonary FunctionBaseline Max MIP79.33 cm of waterStandard Deviation 30.81
Standard of CarePulmonary FunctionBaseline Max MEP114.67 cm of waterStandard Deviation 41.56
Standard of CarePulmonary FunctionDay of Surgery Max MIP90.00 cm of waterStandard Deviation 19.97
Standard of CarePulmonary Function90 Day Max MEP102.75 cm of waterStandard Deviation 19.48
Standard of CarePulmonary Function90 Day Max MIP100.00 cm of waterStandard Deviation 11.53
Secondary

Risk Analysis Index of Frailty (RAI)_questionnaire

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.

Time frame: Baseline, day of surgery, 90 days postoperatively

Population: All participants that completed the RAI assessment were analyzed at each completed timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedRisk Analysis Index of Frailty (RAI)_questionnaireDay of Surgery RAI27.86 score on a scaleStandard Deviation 12.79
ApproachedRisk Analysis Index of Frailty (RAI)_questionnaireBaseline RAI31.57 score on a scaleStandard Deviation 11.86
ApproachedRisk Analysis Index of Frailty (RAI)_questionnaire90 Day RAI29.00 score on a scaleStandard Deviation 10.39
Standard of CareRisk Analysis Index of Frailty (RAI)_questionnaireDay of Surgery RAI29.00 score on a scaleStandard Deviation 5.66
Standard of CareRisk Analysis Index of Frailty (RAI)_questionnaireBaseline RAI24.75 score on a scaleStandard Deviation 0.5
Standard of CareRisk Analysis Index of Frailty (RAI)_questionnaire90 Day RAI26.67 score on a scaleStandard Deviation 2.89
Secondary

Serum Prealbumin

Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.

Time frame: Baseline, day of surgery, 90 days postoperatively

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedSerum PrealbuminBaseline Prealbumin26.5 mg/dLStandard Deviation 4.93
ApproachedSerum PrealbuminDay of Surgery Prealbumin22.5 mg/dLStandard Deviation 6.36
ApproachedSerum Prealbumin90 Day Prealbumin23.6 mg/dLStandard Deviation 8.44
Standard of CareSerum PrealbuminBaseline Prealbumin29 mg/dLStandard Deviation 2.83
Standard of CareSerum PrealbuminDay of Surgery Prealbumin25.5 mg/dLStandard Deviation 2.12
Standard of CareSerum Prealbumin90 Day Prealbumin22 mg/dLStandard Deviation 0
Secondary

Short Physical Performance Battery (SPPB)

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.

Time frame: Baseline, day of surgery, 90 days postoperatively

Population: All participants that completed the SPPB assessments were analyzed at each completed timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedShort Physical Performance Battery (SPPB)Baseline SPPB9.13 score on a scaleStandard Deviation 2.3
ApproachedShort Physical Performance Battery (SPPB)Day of Surgery SPPB10.56 score on a scaleStandard Deviation 0.88
ApproachedShort Physical Performance Battery (SPPB)90 Day SPPB9.8 score on a scaleStandard Deviation 1.79
Standard of CareShort Physical Performance Battery (SPPB)Baseline SPPB10.6 score on a scaleStandard Deviation 1.52
Standard of CareShort Physical Performance Battery (SPPB)Day of Surgery SPPB11 score on a scaleStandard Deviation 0
Standard of CareShort Physical Performance Battery (SPPB)90 Day SPPB10.75 score on a scaleStandard Deviation 0.96
Other Pre-specified

Health Related Quality of Life

Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.

Time frame: Baseline, day of surgery, 90-days postoperatively

Population: Not all participants were analyzed, because this measure requires participants to complete the questionnaire and not all participants did.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedHealth Related Quality of LifeBaseline0.72 score on a scaleStandard Deviation 0.09
ApproachedHealth Related Quality of LifeDay of Surgery0.68 score on a scaleStandard Deviation 0.08
ApproachedHealth Related Quality of Life90-days postoperative0.75 score on a scaleStandard Deviation 0.09
Standard of CareHealth Related Quality of LifeBaseline0.67 score on a scaleStandard Deviation 0.05
Standard of CareHealth Related Quality of LifeDay of Surgery0.77 score on a scaleStandard Deviation 0.01
Standard of CareHealth Related Quality of Life90-days postoperative0.80 score on a scaleStandard Deviation 0.07
Other Pre-specified

Postoperative Mortality

Postoperative mortality

Time frame: 30 and 90 days postoperatively

Population: The mortality questionnaire was completed for all participants still enrolled in the study at the indicated time point.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ApproachedPostoperative Mortality30-days mortality0 Participants
ApproachedPostoperative Mortality90-days mortality1 Participants
Standard of CarePostoperative Mortality30-days mortality0 Participants
Standard of CarePostoperative Mortality90-days mortality0 Participants
Other Pre-specified

Quality of Surgical Care

AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.

Time frame: Day of Surgery and 30-days postoperatively

Population: All participants that completed the assessment were analyzed at each completed timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
ApproachedQuality of Surgical Care30-days Total Communication1.25 score on a scaleStandard Deviation 0.29
ApproachedQuality of Surgical CareDay of Surgery Total Communication1.33 score on a scaleStandard Deviation 0.37
Standard of CareQuality of Surgical CareDay of Surgery Total Communication1.13 score on a scaleStandard Deviation 0.18
Standard of CareQuality of Surgical Care30-days Total Communication1.19 score on a scaleStandard Deviation 0.24

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026