Clinical Trials Directory

Trials / Completed

CompletedNCT03518632

Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)

Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer

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

Summary

The aim of this study is to assess the impact of preoperative physical activity on physical capacities of patients undergoing liver resection for primary or secondary liver cancer.

Detailed description

The purpose of this study is to investigate the effects of a preoperative exercise program in patients with primary or secondary liver cancer undergoing hepatectomy. Preoperative exercise programs have been shown to be effective in other cancer populations, but have been poorly studied in patients with liver cancer. For these patients, it remains unclear what the optimal composition of such programs should be and how they should be delivered. Outcome measures in this study will include preoperative outcomes (oxygen consumption, quality of life, fatigue and physical activity level, anthropometric measures, plasma concentrations of hepatokines) and postoperative outcomes (length of hospital stay and postoperative complications). After the study is explained and consent obtained, subjects will be tested on a submaximal exercise on cycloergometer with gas exchanges analysis and with pre and post blood test. Then, they will answer various questionnaires assessing physical activity, quality of life and fatigue. Patients scheduled for liver resection will be randomized to one of two groups. The first group (experimental group) will be subdivided into two groups: interval training 1 and interval training 2, which differentiate themselves by two different intensities.The second group (control group) will receive standard care. The prehabilitation program will last 6 weeks with 3 sessions per week and will consist in two interval training programs on a cycloergometer with two different intensities. One month after surgery, peri and postoperative complications will be noted.

Conditions

Interventions

TypeNameDescription
BEHAVIORALInterval trainingPatients in experimental group will perform a 6 weeks' physical activity program with 3 sessions per week. Physical activity intervention will consist in 2 different interval training programs on cycloergometer: Interval training 1 and Interval training 2, with a difference in exercise intensities.
OTHERStandard Oncologic carePatients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.

Timeline

Start date
2018-03-27
Primary completion
2020-03-31
Completion
2020-03-31
First posted
2018-05-08
Last updated
2022-07-19

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03518632. Inclusion in this directory is not an endorsement.