Esophageal Cancer, Surgery
Conditions
Brief summary
Consenting patients scheduled for esophageal resection surgery will be randomized to receive standard nutrition counseling (including nutritional supplements as needed) or standard nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery. It is hypothesized that, compared with the group receiving nutrition alone, the addition of physical exercise to nutrition starting before surgery and continuing for 8 weeks after surgery will have a significantly greater impact on functional walking capacity during the prehabilitation period and during the postoperative period, and on the incidence of postoperative pulmonary complications.
Detailed description
A randomized controlled study in patients undergoing esophageal resection for cancer to determine the impact of multimodal prehabilitation on functional exercise capacity and postoperative pulmonary complications. Patients who accept to be enrolled in the study will be randomized to receive either a standard nutritional intervention (including supplements as needed) as per current institution policy or standard nutritional intervention (including supplements as needed) combined with a physical exercise program before and after surgery. Specific aims The aims of this research project are the following: 1. To determine the extent in which a multimodal prehabilitation regimen optimizes functional recovery in patients suffering from esophageal cancer and the incidence of postoperative pulmonary complications. 2. To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.
Interventions
BEHAVIORALExercise
The exercise component will consist of 20 min of general exercise training, 3 days per week, alternating between aerobic and resistance training. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard) and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 of heart rate reserve, HRR), or 25 min of resistance training (5 exercises targeting major muscle groups performed at an intensity of 8-12 repetition maximum), and a 5 min cool-down.
Sponsors
Franco Carli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 and older * referred electively for resection of malignant esophageal lesion
Exclusion criteria
* American Society of Anesthesiologists (ASA) health status class 4-5 * Dementia and psychosis * Disabling orthopedic and neuromuscular disease * Severe cardiac abnormalities * Severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV) * COPD * renal failure (creatinine \> 1.5 mg/dl, and hepatic failure ALT and AST \>50% over the normal range) * Morbid obesity (BMI \>30) * Anemia (hematocrit \< 30 %, haemoglobin \<10g/dl, albumin \< 25mg/dl)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk test (6MWT) | up to 8 weeks after surgery | The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines. |
Countries
Canada
Outcome results
None listed