Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02024776
Enrollment
141
Registered
2013-12-31
Start date
2014-02-01
Completion date
2017-01-30
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgical Patient, High-risk Patient

Keywords

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

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.

Interventions

BEHAVIORALPrehabilitation

Tailored exercise training program

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative complications, classified by Clavien ScaleTime Frame: 30days or the postoperative hospital stay if longer than 30 days

Secondary

MeasureTime frame
Length of stay30 days or the postoperative hospital stay if longer than 30 days

Other

MeasureTime frame
Mortality6 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
Analysis of the barriers for the use of communication and information technologies in prehabilitation programFrame: 6 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026