Prehabilitation for Esophageal Resection Surgery

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

About this study

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:

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.
To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

6 minute walk test (6MWT)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Franco Carli

Other

Registry information

Official study title

Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Aug 16, 2012
Registry last updated: Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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