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Prehabilitation for Esophageal Resection Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Franco Carli, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01666158
First received: August 14, 2012
Last updated: November 18, 2014
Last verified: November 2014

August 14, 2012
November 18, 2014
January 2013
September 2015   (final data collection date for primary outcome measure)
6 minute walk test (6MWT) [ Time Frame: up to 8 weeks after surgery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01666158 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prehabilitation for Esophageal Resection Surgery
Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Esophageal Cancer
  • Surgery
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.
  • Active Comparator: 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.
    Intervention: Behavioral: Exercise
  • No Intervention: Standard nutrition counselling
    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. This group will receive general instructions on exercises (breathing, ankle rotation) to be done during hospital stay by kinesiologist.
Mayo NE, Feldman L, Scott S, Zavorsky G, Kim do J, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
September 2015
September 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Dr.Franco Carli, M.D. (514) 934-1934 ext 43261 franco.carli@mcgill.ca
Contact: Dr.Shruthi Ramachandran, M.D (514) 934-1934 ext 43728 shruthir81@gmail.com
Canada
 
NCT01666158
12-171-SDR
Yes
Franco Carli, McGill University Health Center
Franco Carli
Not Provided
Principal Investigator: Franco Carli, M.D. Montreal University Health Centre
McGill University Health Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP