Clinical trial NCT02024776: Effectiveness of Prehabilitation Program for High-risk Patients Underwent Abdominal Surgery
Official title: The Effectiveness of Tailored Physical Training Intervention (Prehabilitation) in High-risk Patients Underwent Major Abdominal Surgery on Postoperative Complications: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Surgical Patient
High-risk Patient
Keywords: Training
Wellness
Aerobic capacity
Information and communication technology, surgical risk
Abdominal surgery
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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:

* Unstable severe co-morbid disease
* Dementia and psychosis, severe mental disorder or substance abuse or dependence
* Disabling orthopedic and neuromuscular disease.

Primary outcomes:
measure: The incidence of postoperative complications, classified by Clavien Scale
timeFrame: Time Frame: 30days or the postoperative hospital stay if longer than 30 days
Secondary outcomes:
measure: Length of stay
timeFrame: 30 days or the postoperative hospital stay if longer than 30 days
Other outcomes:
measure: Mortality
timeFrame: 6 months
measure: Training induced enhancement of aerobic capacity : VO2 max, Endurance time, 6 MWT (m)
timeFrame: baseline, after the 4-6 week endurance training program (before surgery), and at 3 and 6 months follow-up
measure: Health-related quality of life (SF-36)
timeFrame: at baseline and after the 4-6 week endurance training program(before surgery), and at 3 and 6 months follow-up
measure: Analysis of the barriers for the use of communication and information technologies in prehabilitation program
timeFrame: Frame: 6 weeks
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic de Barcelona, IDIBAPS
name: Graciela Martinez Palli
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.