Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227526
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2005-09-27
Brief Title:
Enhancing Outcomes After Colon Surgery
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Enhancing Outcomes After Colon Surgery Role of Prehabilitation Facilitating the Recovery Process
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Most patients find that recovering from surgery is difficult particularly after abdominal surgery for cancer or other intestinal disorders The surgical stress healing process and concerns if further treatments are required suggest that the post-operative period may not be the best time to get people to exercise to rehabilitate lost functions Prehabilitation is the process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor such as surgery and this study aims to evaluate the effectiveness of prehabilitation for colorectal surgery Two groups will be formed by a random process and the prehabilitation group will use an exercise cycle and weights to build endurance and strength for a 3-week period prior to surgery The other group will receive training about exercises that will help them move better after surgery People who are malnourished prior to surgery will receive nutritional supplements The results of this trial will be used to inform practitioners and patients alike of the benefits or risks if any of exercise in preparing for surgery
Detailed Description:
The surgical process is a major stressor because of the psychological distress tissue trauma lack of activity and quasi-starvation and it produces immediate systemic changes and both short- and long-term effects on activity and quality of life However there is mounting evidence that many of the negative immediate effects of surgery such as pain fatigue and weakness are amenable to intervention If proper interventions are carried out these symptoms may be readily controlled allowing for a faster recovery and early home discharge But the effects of surgery are felt far beyond the immediate convalescent period and patients can feel fatigued for many weeks and this delays return to usual function and reduces quality of life Thus it would be of great practical benefit if ways of improving post-surgery physical function and quality of life could be identified
Traditionally efforts have been made to improve the recovery process by intervening in the post-operative period However the post-operative period may not be the most opportune time to introduce interventions to accelerate recovery Many of these surgical patients are concerned about perturbing the healing process as well as being depressed and anxious if they await further treatment The pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery The process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor has been termed prehabilitation The purpose of this study is to address the following research question Among persons scheduled for colorectal surgery does a pre-operative program of aerobic and muscle strength training prehabilitation compared to a standard peri-operative educational protocol affect functional exercise capacity and health-related quality of life The trial will be a single blind stratified on cancer diagnosis or not randomized two-group prehabilitation or standard care parallel design Both groups will receive the same peri-operative education program In conformity with current practice all subjects will also be advised on nutritional support during the preoperative period Persons with albumin 38 gml will receive an adequate supply of protein and calorie nutritional supplement bars In addition to this standard care the prehabilitation group will be prescribed a program of exercise training consisting of daily stationary cycling from the start of the intervention to the day prior to surgery minimum 3 weeks combined with an individualized program of muscle strength training
Both groups will be evaluated for exercise tolerance walking capacity and health and emotional status at enrolment and after 3 three weeks of training as well as at 4 weeks 8 weeks and 24 weeks 6 months post-surgery The main outcome measure will be the 6 Minute Walk Test - a valid and reliable measure of functional walking capacity The estimator of effect will be the proportion of people in each group who at 8 weeks post-surgery achieve or exceed their baseline value on this test 20m The proposed sample size is 200 This is based on 80 power to detect a difference of 22 in the proportion recovering to baseline values 40 in standard and 62 in prehabilitation The results of this trial will be used to inform practitioners and patients alike of the benefits or risks if any of exercise in preparing for surgery
Traditionally efforts have been made to improve the recovery process by intervening in the post-operative period However the post-operative period may not be the most opportune time to introduce interventions to accelerate recovery Many of these surgical patients are concerned about perturbing the healing process as well as being depressed and anxious if they await further treatment The pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery The process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor has been termed prehabilitation The purpose of this study is to address the following research question Among persons scheduled for colorectal surgery does a pre-operative program of aerobic and muscle strength training prehabilitation compared to a standard peri-operative educational protocol affect functional exercise capacity and health-related quality of life The trial will be a single blind stratified on cancer diagnosis or not randomized two-group prehabilitation or standard care parallel design Both groups will receive the same peri-operative education program In conformity with current practice all subjects will also be advised on nutritional support during the preoperative period Persons with albumin 38 gml will receive an adequate supply of protein and calorie nutritional supplement bars In addition to this standard care the prehabilitation group will be prescribed a program of exercise training consisting of daily stationary cycling from the start of the intervention to the day prior to surgery minimum 3 weeks combined with an individualized program of muscle strength training
Both groups will be evaluated for exercise tolerance walking capacity and health and emotional status at enrolment and after 3 three weeks of training as well as at 4 weeks 8 weeks and 24 weeks 6 months post-surgery The main outcome measure will be the 6 Minute Walk Test - a valid and reliable measure of functional walking capacity The estimator of effect will be the proportion of people in each group who at 8 weeks post-surgery achieve or exceed their baseline value on this test 20m The proposed sample size is 200 This is based on 80 power to detect a difference of 22 in the proportion recovering to baseline values 40 in standard and 62 in prehabilitation The results of this trial will be used to inform practitioners and patients alike of the benefits or risks if any of exercise in preparing for surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None