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

Hospital Clinic of Barcelona

Status: Completed

Conditions: High-risk Patient; Abdominal Surgical Patient

Treatments: Behavioral: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02024776

PI13/00425 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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141 participants in 2 patient groups

Prehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Prehabilitation

No-intervention

No Intervention group

Description:

Standard counseling and conventional pre-surgical measures