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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Norwegian School of Sport Sciences | OTHER |
| Oslo University Hospital | OTHER |
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In patients with cancer, resistance training appears to be a safe and effective exercise modality to increase both lean muscle mass and strength, as well as attenuates cancer-related fatigue. It may serve as a feasible intervention in these patients to mitigate cachexia, especially if implemented before the onset of cancer cachexia or in a pre-cachectic state. This study is a multicenter randomized controlled trial that will compare a blood flow restricted resistance training intervention during the pre- (prehabilitation) and post-operative (rehabilitation) phase in patients with pancreatic, biliary tract and liver cancer, versus usual care on skeletal muscle and other health-related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | The experimental group will in addition to standard care receive supervised and home-based exercise training program with a specific focus to induce metabolic stress (blood flow restriction exercise), and protein supplementation to ensure adequate protein intake. |
|
| Usual care | No Intervention | The control group will in addition to standard care receive protein supplementation to ensure adequate protein intake. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Other | The intervention group will receive an exercise program consisting of a combination of supervised and home-based exercise with a focus to induce metabolic stress (blood flow restriction exercise) during both a pre- and postoperative period consisting of a total of 6-10 weeks. Protein supplementation will be given to exclude insufficient intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle thickness | Skeletal muscle thickness (mm) measured through ultrasound | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). |
| Skeletal muscle cross sectional area | Skeletal muscle cross sectional area (um2) measured through ultrasound | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle morphology | Skeletal muscle morphology (au) measured through microscopy methods in skeletal muscle biopsies | Change from baseline (T0) to: 10-13 weeks (T3). |
| Skeletal muscle protein levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Mijwel, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway | ||||
| Karolinska University Hopsital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39606939 | Derived | Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518. | |
| 38835083 | Derived |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Skeletal muscle protein levels (au) measured through western blot in skeletal muscle biopsies
| Change from baseline (T0) to: 10-13 weeks (T3). |
| Skeletal muscle metabolism | Skeletal muscle metabolism (au) measured through biochemical methods in skeletal muscle biopsies | Change from baseline (T0) to: 10-13 weeks (T3). |
| Body lean mass | Lean mass (kg) measured through bioimpedance and CT scan | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). |
| Body fat mass | Fat mass (kg) measured through bioimpedance and CT scan | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). |
| Handgrip strength | Maximal handgrip strength (kg) measured through hand dynamometry | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). |
| Lower limb muscle strength | Maximal leg strength (kg) measured through isometric force measurements | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). |
| Health-related quality of life | Disease specific helath related quality of life measured with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) Summary Score (0-100 points with a higher score indicating a better quality of life) | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). |
| Physical performance | Short Physical Performance Battery (SPPB score points ranging from 0-12 with a higher score indicating a better physical function) measured through handgrip strength test, leg strength test, endurance test | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3). |
| Cancer-related fatigue | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Fatigue12 (EORTC-QLQ-FA12) Summary Score (0-100 points with a higher score indicating a better quality of life) | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). |
| Nutritional status | Subjective Global Assessment Form scores (score ranging between 7 (normal) and 35 (severely malnourished) | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). |
| Participants' experience of the exercise program | Focus group and individual interviews | 3 months |
| Treatment related complications | days to recover after surgery will be assessed retrospectively through the patients' medical records. | 4-7 weeks (T2) |
| Hospitalization | days of being hospitalized will be assessed retrospectively through the patients' medical records. | 5-6 months (T4) |
| Physical activity | Measured through an activity tracker (hours) | Change from baseline (T0) to: 1-4 weeks (T1), 4-7 weeks (T2), 10-13 weeks (T3), 5-6 months (T4). |
| Inflammatory markers | Inflammation (au) will be assessed from blood serum and plasma. | Change from baseline (T0) to: 10-13 weeks (T3) |
| Prognostic markers | Prognostic markers (au) will be assessed from blood serum and plasma. | Change from baseline (T0) to: 10-13 weeks (T3) |
| Stockholm |
| Sweden |
| Anandavadivelan P, Cardinale D, Blomhoff R, Sunde B, Lassen K, Kleive D, Sturesson C, Gilg S, Raastad T, Mijwel S. Blood flow restriction Exercise in the perioperative setting to Prevent loss of muscle mass in patients with pancreatic, biliary tract, and liver cancer: study protocol for the PREV-Ex randomized controlled trial. Trials. 2024 Jun 4;25(1):356. doi: 10.1186/s13063-024-08207-5. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
| D008107 | Liver Diseases |