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| Name | Class |
|---|---|
| Canadian Donation and Transplantation Research Program | UNKNOWN |
| Canadian Association for the Study of the Liver | UNKNOWN |
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This study will assess the feasibility, safety and effectiveness of a structured prehabilitation program combining exercise training, nutritional optimization and psychological support for patients with cirrhosis awaiting liver transplantation.
Due to their chronic liver disease, patients with cirrhosis awaiting liver transplantation develop low muscle mass, poor nutritional status and decreased reserves putting them at high risk of postoperative complications, prolonged hospital stay, and failed discharge home after liver transplantation. Prehabilitation aims to optimize a patient before they undergo a major surgery. These programs combine exercise training, with nutritional optimization and psychological support. Together, these contribute to improve their muscle mass, tolerance to exercise, and nutritional status. The current study will assess whether an individualized and structured prehabilitation program combining supervised exercise training, nutritional optimization and psychological support will benefit patients with cirrhosis awaiting liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | Multimodal prehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | All participants will be offered a multimodal prehabilitation program. This program will include an individualized and supervised aerobic and resistance exercise training program, nutritional optimization, and psychological support. The program will last 6 months or until liver transplantation, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention | Proportion of participants that adhere to the intervention protocol | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the intervention | Incidence of intervention-related adverse events | 24 weeks |
| Impact of exercise program on frailty | Interval change in liver frailty index, where a higher value indicates a higher degree of frailty |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amine Benmassaoud, MD | Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H3G1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38925705 | Derived | Benmassaoud A, Gillis C, Geraci O, Martel M, Awasthi R, Barkun J, Chen T, Edgar L, Sebastiani G, Carli F, Bessissow A. Prehabilitation in patients with cirrhosis awaiting liver transplantation: protocol of a feasibility study. BMJ Open. 2024 Jun 25;14(6):e081362. doi: 10.1136/bmjopen-2023-081362. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D000073496 | Frailty |
| D009043 | Motor Activity |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| At end of week-4, week-14, and week-24 |
| Impact of nutritional program on nutritional status | Interval change in Royal Free Hospital Global Assessment status, where participants are classified as well nourished, moderately malnourished, or severely malnourished | At end of week-4, week 14, and week-24 |
| Impact of psychological program on health-related quality of life | Interval change in the Chronic Liver Disease Questionnaire (CLDQ) score where lower values indicate worse health-related quality of life. | At end of week-4, week 14, and week-24 |
| D001519 | Behavior |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |