Prehabilitation for Esophageal Resection Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 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: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Esophageal Cancer
Surgery
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 68
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666158

Contacts
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

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
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   
Principal Investigator: Franco Carli, M.D.         
Sponsors and Collaborators
Franco Carli
Investigators
Principal Investigator: Franco Carli, M.D. Montreal University Health Centre
  More Information

Publications:
Responsible Party: Franco Carli, Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01666158     History of Changes
Other Study ID Numbers: 12-171-SDR
Study First Received: August 14, 2012
Last Updated: October 23, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 25, 2014