Prehabilitation for Esophageal Resection Surgery

Not Applicable

Completed

• Conditions: Esophageal Cancer; Surgery
• Interventions: Behavioral: Exercise

• Registration Number: NCT01666158
• Lead Sponsor: Franco Carli

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.

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Study Start: 2013-01
• Status Verified: 2016-09
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. Additionally, these patients will be given a specific physical exercise program before and after surgery by kinesiologist.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada