Effectiveness of Prehabilitation Program for High-risk Patients Underwent Abdominal Surgery

NCT02024776 | Completed

• 1 other identifier: PI13/00425
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgical Patient; High-risk Patient

Keywords

Training; Wellness; Aerobic capacity; Information and communication technology, surgical risk; Abdominal surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative complications, classified by Clavien Scale

  Time Frame: 30days or the postoperative hospital stay if longer than 30 days

Secondary Outcomes (1)

• Length of stay

  30 days or the postoperative hospital stay if longer than 30 days

Other Outcomes (4)

• 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

• 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

Study Arms (2)

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.

Behavioral: Prehabilitation

No-intervention

NO INTERVENTION

Standard counseling and conventional pre-surgical measures

Interventions

Prehabilitation BEHAVIORAL

Tailored exercise training program

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 31248644 DERIVED

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Graciela Martinez Palli

  Hospital Clinic de Barcelona, IDIBAPS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: February 1, 2014
• Primary Completion: August 30, 2016
• Study Completion: January 30, 2017
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

ES (1)