Prehabilitation for Esophageal Resection Surgery

NCT ID: NCT01666158

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-07-31

Brief 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.

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.

Conditions

Esophageal Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Franco Carli

OTHER

Sponsor Role: lead

Responsible Party

Franco Carli

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Franco Carli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Montreal University Health Centre

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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: 10.1016/j.surg.2011.07.045.

Reference Type: RESULT

PMID: 21878237 (View on PubMed)

Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.

Reference Type: DERIVED

PMID: 30193337 (View on PubMed)

Other Identifiers

12-171-SDR

Identifier Type: -

Identifier Source: org_study_id