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

High-risk Patient Clinical Trial

Official title:

The Effectiveness of Tailored Physical Training Intervention (Prehabilitation) in High-risk Patients Underwent Major Abdominal Surgery on Postoperative Complications: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024776
• Other study ID #: PI13/00425
• Secondary ID: PI13/00425
• Status: Completed
• Phase: N/A
• Start date: February 1, 2014
• Est. completion date: January 30, 2017

Study information

• Verified date: April 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 30, 2017
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgical Patient
• High-risk Patient
• Postoperative Complications

Intervention

Behavioral:
• Prehabilitation
Tailored exercise training program

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality		6 months
Other	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
Other	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
Other	Analysis of the barriers for the use of communication and information technologies in prehabilitation program		Frame: 6 weeks
Primary	The incidence of postoperative complications, classified by Clavien Scale		Time Frame: 30days or the postoperative hospital stay if longer than 30 days
Secondary	Length of stay		30 days or the postoperative hospital stay if longer than 30 days