Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)
APACHE
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2018
CompletedFirst Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJuly 19, 2022
July 1, 2020
2 years
April 6, 2018
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Oxgen consumption at anaerobic threshold :
Oxygen consumption at anaerobic threshold will be assessed at baseline and at the end of the 6 weeks' program with a submaximal exercise performed on cycloergometer
6 weeks
Secondary Outcomes (7)
Postoperative complications with the Dindo Clavien classification :
One month after surgery
Intensive care stay :
One month after surgery
Changes of Hepatokines plasmatic concentrations :
Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Hepatokines plasmatic concentrations :
Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks
Changes in Physical activity level :
Comparison between baseline, after the 6 weeks' program
- +2 more secondary outcomes
Study Arms (3)
Control group
ACTIVE COMPARATORInterval training 1
EXPERIMENTALInterval training 2
EXPERIMENTALInterventions
Patients 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.
Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Célia Turcolead
Study Sites (1)
Chirurgie digestive, viscérale et cancérologique
Besançon, 25000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2018
First Posted
May 8, 2018
Study Start
March 27, 2018
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
July 19, 2022
Record last verified: 2020-07