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Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection

18 Years
Open (Enrolling)
Esophageal Cancer, Surgery

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Trial Information

Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection

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.

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


- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

6 minute walk test (6MWT)

Outcome Description:

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.

Outcome Time Frame:

up to 8 weeks after surgery

Safety Issue:


Principal Investigator

Franco Carli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montreal University Health Centre


Canada: Ethics Review Committee

Study ID:




Start Date:

January 2013

Completion Date:

April 2014

Related Keywords:

  • Esophageal Cancer
  • Surgery
  • Esophageal Diseases
  • Esophageal Neoplasms