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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator |
| |
| Interval training 1 | Experimental |
| |
| Interval training 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interval training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications with the Dindo Clavien classification : | Postoperative complications will be assessed using the Dindo Clavien classification which consists in a 7 grades classification (I, II, IIIa, IIIb, IVa, IVb and V). | One month after surgery |
| Intensive care stay : |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chirurgie digestive, viscérale et cancérologique | Besançon | 25000 | France |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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|
| Standard Oncologic care | Other | Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises. |
|
Postoperative intensive care stay will be evaluated (number of days). |
| One month after surgery |
| Changes of Hepatokines plasmatic concentrations : | Fetuin A (ng/mL) concentrations will be analyzed. | Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks |
| Hepatokines plasmatic concentrations : | Fibroblast Growth Factor 21 (FGF21) (pg/mL) concentrations will be analyzed. | Comparison between plasmatic concentrations pre-exercise (day 1), post exercise (day 1) and at 6 weeks |
| Changes in Physical activity level : | Physical activity level will be measured using the long-form of the International Physical Activity Questionnaire (IPAQ). It consist in a description of the physical activity level by assessing 5 activity domains during the 7 last days. Physical activity level is expressed in Metabolic Equivalent Tasks (METs). It enables to classify patients in 3 categories : low physical activity level, moderate physical activity level and high physical activity level. | Comparison between baseline, after the 6 weeks' program |
| Changes in Quality of life : | Health related quality of life will be measured with the EORTC Quality of Life Questionnaire QLQ-C30 which is a cancer specific questionnaire. It consists in 30 items to measure 15 dimensions of quality of life. It generates a score between 0 and 100. A higher score means a higher quality of life level. | Comparison between baseline, after the 6 weeks' program |
| Changes in Fatigue : | Fatigue will be measured with the Quality of Life Questionnaire QLQ-FA12 which enables to assess cancer related fatigue. It consists in 12 items to measure 5 dimension go health related fatigue. It generates a score between 0 and 100. A higher score means a higher fatigue level. | Comparison between baseline, after the 6 weeks' program |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |