Clinical trial NCT03518632: Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)
Official title: Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Liver Cancer
Secondary Liver Cancer
Liver Metastases
Keywords: Exercise
Adapted physical activity
preoperative
liver resection
hepatectomy
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Men and women aged \>18 years old.
* Patients with primary liver cancer, biliary tract cancer, liver metastasis endorsed in the University Hospital of Besancon
* No opposition of patients
* Join a French social security or receiving such a scheme

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Patients being in the disqualification of another study or under the national register of volunteers
* Patients unlikely to cooperate or anticipated low cooperation
* Patients with a maximal oxygen consumption above 35 ml/min/kg

Primary outcomes:
measure: Change of Oxgen consumption at anaerobic threshold :
timeFrame: 6 weeks
Secondary outcomes:
measure: Postoperative complications with the Dindo Clavien classification :
timeFrame: One month after surgery
measure: Intensive care stay :
timeFrame: One month after surgery
measure: Changes of Hepatokines plasmatic concentrations :
timeFrame: Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
measure: Hepatokines plasmatic concentrations :
timeFrame: Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
measure: Changes in Physical activity level :
timeFrame: Comparison between baseline, after the 6 weeks' program
measure: Changes in Quality of life :
timeFrame: Comparison between baseline, after the 6 weeks' program
measure: Changes in Fatigue :
timeFrame: Comparison between baseline, after the 6 weeks' program
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chirurgie digestive, viscérale et cancérologique
Study officials:
References: