Trial Outcomes & Findings for Nutritional Perihabilitation in Older Veterans Undergoing Surgery (NCT NCT03073811)
NCT ID: NCT03073811
Last Updated: 2025-04-01
Results Overview
Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
PeriHab
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery.
|
PoshControl
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutritional Perihabilitation in Older Veterans Undergoing Surgery
Baseline characteristics by cohort
| Measure |
PeriHab
n=26 Participants
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.
|
PoshControl
n=24 Participants
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
73.9 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
73.9 years
STANDARD_DEVIATION 6.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 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
|
14 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
31 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
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Short Physical Performance Battery
|
8.2 units on a scale
STANDARD_DEVIATION 2.6 • n=99 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 2.4 • n=107 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Cancer Diagnosis
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Body weight, lbs
|
177.4 lbs
STANDARD_DEVIATION 32.9 • n=99 Participants
|
195.1 lbs
STANDARD_DEVIATION 48.6 • n=107 Participants
|
189.9 lbs
STANDARD_DEVIATION 41.7 • n=206 Participants
|
|
Body Mass Index, kg/m^2
|
26.4 kg/m2
STANDARD_DEVIATION 4.1 • n=99 Participants
|
28.5 kg/m2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
27.4 kg/m2
STANDARD_DEVIATION 5.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.
Outcome measures
| Measure |
PeriHab
n=26 Participants
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery.
|
PoshControl
n=24 Participants
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
|
|---|---|---|
|
Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Day of Surgery
|
23 Participants
|
20 Participants
|
|
Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Postoperative Follow-up
|
19 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 30-day post-surgery follow-up (endpoint)Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree
Outcome measures
| Measure |
PeriHab
n=19 Participants
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery.
|
PoshControl
n=16 Participants
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
|
|---|---|---|
|
Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
|
4.6 units on a scale
Standard Deviation 0.6
|
4.9 units on a scale
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgeryPopulation: Perihab (midpoint; n=23) - surgery was cancelled (n=3) PoshControl (midpoint; n=18) - surgery was cancelled (n=3), dropped (n=1); surgery time changed (n=2) Perihab (endpoint; n=18) - surgery was cancelled morning of surgery (n=2); death (n=1); COVID (n=2) PoshControl (n=16; endpoint) - surgery was cancelled morning of surgery (n=2); death (n=1); hospitalization (n=1)
Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)
Outcome measures
| Measure |
PeriHab
n=26 Participants
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery.
|
PoshControl
n=24 Participants
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
|
|---|---|---|
|
Physical Function
Baseline
|
8.2 score on a scale
Standard Deviation 2.6
|
7.9 score on a scale
Standard Deviation 2.4
|
|
Physical Function
Morning of Surgery (midpoint)
|
9.7 score on a scale
Standard Deviation 2.3
|
9.0 score on a scale
Standard Deviation 2.0
|
|
Physical Function
30 day postop (endpoint)
|
9.0 score on a scale
Standard Deviation 2.9
|
8.8 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: endpoint (30 days post-surgery)determine from medical records
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)Three day food records will be collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: endpoint (30 days post-surgery)determine from medical records
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: endpoint (30 days post-surgery)determine from medical records
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: endpoint (30 days post-surgery)Prevalence of emergency department admissions following surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: endpoint (30 days post-surgery)determine from medical records
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)A measure of protein in the blood. Lower level may indicate infection or inflammation.
Outcome measures
Outcome data not reported
Adverse Events
PeriHab
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
PoshControl
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PeriHab
n=26 participants at risk
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery.
|
PoshControl
n=24 participants at risk
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
|
|---|---|---|
|
Surgical and medical procedures
Surgery site infection
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
0.00%
0/24 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath and Cough
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
0.00%
0/24 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/26 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
4.2%
1/24 • Number of events 1 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
Other adverse events
| Measure |
PeriHab
n=26 participants at risk
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery.
|
PoshControl
n=24 participants at risk
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Swelling in foot
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
0.00%
0/24 • Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
|
Additional Information
Kathryn Starr, PhD, RD; Research Health Scientist
Durham VA Health Care System
Phone: 919-660-7571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place