Clinical Trials Directory

Trials / Completed

CompletedNCT01666158

Prehabilitation for Esophageal Resection Surgery

Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
68 (actual)
Sponsor
Franco Carli · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALExerciseThe 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.

Timeline

Start date
2013-01-01
Primary completion
2017-07-01
Completion
2017-07-01
First posted
2012-08-16
Last updated
2018-03-21

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01666158. Inclusion in this directory is not an endorsement.