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| ID | Type | Description | Link |
|---|---|---|---|
| PI13/00425 | Other Grant/Funding Number | Instituto de Salud Carlos III |
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Despite recent advances, morbidity and mortality associated to major abdominal surgery is significant. A poor physical condition and functional status reduces the ability of a person to cope, mentally and physically, with hospitalization and surgery and may compromise functional recovery, potentially leading to postoperative complications and death. Prehabilitation aims to enhance functional capacity preoperatively for better toleration of surgery and to facilitate recovery and eventually the prognosis of the surgical patient. Whereas the benefits of cardiopulmonary fitness programs are well established, the accessibility, sustainability of effects, and impact on the surgical outcome of these programs are unsolved issues. Wellness programs based on integrated care services supported by Information and Communication Technology (ICT) can overcome such limitations. The investigators hypothesized that a prehabilitation program, inducing beneficial effects on exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT support may contribute to increase the adherence and sustainability of this intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Active Comparator | Prehabilitation program is defined as a tailored physical exercise program to be carried out to a patient on the basis of his/her health condition, social circumstances and adherence profile. The intervention consisted of a standard 4-6 week supervised outpatient program including global endurance exercise training, or educational sessions followed by a self-management program supported by ICT during the follow-up period, or a combination of both. |
|
| No-intervention | No Intervention | Standard counseling and conventional pre-surgical measures |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | Tailored exercise training program |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative complications, classified by Clavien Scale | Time Frame: 30days or the postoperative hospital stay if longer than 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | 30 days or the postoperative hospital stay if longer than 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 6 months | |
| Training induced enhancement of aerobic capacity : VO2 max, Endurance time, 6 MWT (m) | baseline, after the 4-6 week endurance training program (before surgery), and at 3 and 6 months follow-up |
Inclusion Criteria:
Patients over 70 years-old and/or American Society of Anesthesiologists (ASA) health status class III-IV, with a DASI (Duke Activity Score Index) <46 points, referred for scheduled major abdominal surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graciela Martinez Palli | Hospital Clinic de Barcelona, IDIBAPS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31248644 | Derived | Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25. |
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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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| Health-related quality of life (SF-36) | at baseline and after the 4-6 week endurance training program(before surgery), and at 3 and 6 months follow-up |
| Analysis of the barriers for the use of communication and information technologies in prehabilitation program | Frame: 6 weeks |
| 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 |