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

NCT ID: NCT02024776

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-01
• Study Completion Date: 2017-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Prehabilitation

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.

Group Type: ACTIVE_COMPARATOR

Prehabilitation

Intervention Type: BEHAVIORAL

Tailored exercise training program

No-intervention

Standard counseling and conventional pre-surgical measures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prehabilitation

Tailored exercise training program

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Graciela Martinez-Palli

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Graciela Martinez Palli

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic de Barcelona, IDIBAPS

Locations

Hospital Clinic de Barcelona

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 31248644 (View on PubMed)

Other Identifiers

PI13/00425

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI13/00425

Identifier Type: -

Identifier Source: org_study_id