Trial Outcomes & Findings for Trimodal Prehabilitation for Aneurysm Surgery Study (NCT NCT02292927)
NCT ID: NCT02292927
Last Updated: 2019-07-17
Results Overview
This describes the number of people within the study who were in the pre-habilitation study arm that accepted and completed the pre-habilitation training
COMPLETED
NA
25 participants
Collected at screening
2019-07-17
Participant Flow
Participant milestones
| Measure |
Pre-intervention
Patients treated as standard before intervention
|
Post-intervention
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
Reasons for withdrawal
| Measure |
Pre-intervention
Patients treated as standard before intervention
|
Post-intervention
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
|---|---|---|
|
Overall Study
Protocol Violation
|
13
|
7
|
Baseline Characteristics
Trimodal Prehabilitation for Aneurysm Surgery Study
Baseline characteristics by cohort
| Measure |
Baseline Pre
n=13 Participants
Baseline Characteristics of the Pre-intervention Standard of Care
|
Baseline Post
n=12 Participants
Baseline Characteristics of the Post-intervention Prehabilitation
|
Total
n=25 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
74.3 years
n=5 Participants
|
70.8 years
n=7 Participants
|
72.64 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected at screeningThis describes the number of people within the study who were in the pre-habilitation study arm that accepted and completed the pre-habilitation training
Outcome measures
| Measure |
Post-intervention
n=12 Participants
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
Pre-intervention
Before the introduction of a rehabilitation programme
|
|---|---|---|
|
The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme
|
11 participants
|
—
|
PRIMARY outcome
Timeframe: Collected at baseline and (expected) 6 weeksPopulation: There were no patients in the pre-intervention group who underwent pre-operative METS testing
• Metabolic equivalent level is a measure of physical fitness. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival," or similar definition that is accurate and appropriate.
Outcome measures
| Measure |
Post-intervention
n=5 Participants
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
Pre-intervention
Before the introduction of a rehabilitation programme
|
|---|---|---|
|
Change From Baseline in Metabolic Equivalents (METS) at Six Weeks
|
0.06 METS
Interval 0.0 to 0.1
|
—
|
PRIMARY outcome
Timeframe: Collected at baseline and (expected) 6 weeksPopulation: There were no patients in the pre-intervention group who underwent pre-operative HADS testing
HADS is a validated questionnaire consisting of 7 statements relating to anxiety and 7 statements relating to depression. Each statement is scored between 0 and 3 giving a total score of up to 21 for each section. A score of 0-7 is assumed to be normal and score greater than this suggestive of a mood disorder
Outcome measures
| Measure |
Post-intervention
n=5 Participants
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
Pre-intervention
Before the introduction of a rehabilitation programme
|
|---|---|---|
|
Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale)
HADS - D
|
1.2 HADS scores
Interval -3.0 to 4.0
|
—
|
|
Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale)
HADS - A
|
5 HADS scores
Interval -2.0 to 9.0
|
—
|
PRIMARY outcome
Timeframe: Collected at baseline and during the studyOutcome measures
| Measure |
Post-intervention
n=12 Participants
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
Pre-intervention
Before the introduction of a rehabilitation programme
|
|---|---|---|
|
Number of Participants With Attendance at the Physical and Psychological and Social Training Appointments of the Rehabilitation Programme (Assessed by Bespoke Questionnaire)
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Collected at (expected) 6 weeks +hospital stayPopulation: The number of participants where post operative HDU/ITU stay information was available was significantly reduced as this information was not collected by the study reporting team.
Observation to power a larger intervention study
Outcome measures
| Measure |
Post-intervention
n=4 Participants
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
Pre-intervention
n=7 Participants
Before the introduction of a rehabilitation programme
|
|---|---|---|
|
HDU/ITU Resource Use (Number of Days Stay)
|
1.75 Days
Interval 1.0 to 3.0
|
2.42 Days
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Collected at (expected) 6 weeks +hospital stayPopulation: The number of participants where length of hospital stay information was available was significantly reduced as this information was not collected by the study reporting team.
Length of hospital stay after aortic surgery (number of days) - Observation to power a larger intervention study
Outcome measures
| Measure |
Post-intervention
n=7 Participants
Patients after the institution of a physical, psychological and social training programme
Prehabilitation: Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
|
Pre-intervention
n=4 Participants
Before the introduction of a rehabilitation programme
|
|---|---|---|
|
LOS
|
5.5 days
Interval 4.0 to 8.0
|
5.14 days
Interval 2.0 to 7.0
|
Adverse Events
Post-intervention
Pre-intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place