Prehabilitation for Esophageal Resection Surgery

Surgery Clinical Trial

Official title:

Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666158
• Other study ID #: 12-171-SDR
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: March 20, 2018
• Start date: January 2013
• Est. completion date: July 2017

Study information

• Verified date: September 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Surgery

Intervention

Behavioral:
• Exercise
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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Franco Carli

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test (6MWT)	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.	up to 8 weeks after surgery