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

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ClinicalTrials.gov Identifier: NCT02024776
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Graciela Martinez-Palli, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Abdominal Surgical Patient High-risk Patient Behavioral: Prehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness of Tailored Physical Training Intervention (Prehabilitation) in High-risk Patients Underwent Major Abdominal Surgery on Postoperative Complications: Randomized Controlled Trial
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : August 30, 2016
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Prehabilitation
Tailored exercise training program

No Intervention: No-intervention
Standard counseling and conventional pre-surgical measures



Primary Outcome Measures :
  1. The incidence of postoperative complications, classified by Clavien Scale [ Time Frame: Time Frame: 30days or the postoperative hospital stay if longer than 30 days ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 30 days or the postoperative hospital stay if longer than 30 days ]

Other Outcome Measures:
  1. Mortality [ Time Frame: 6 months ]
  2. Training induced enhancement of aerobic capacity : VO2 max, Endurance time, 6 MWT (m) [ Time Frame: baseline, after the 4-6 week endurance training program (before surgery), and at 3 and 6 months follow-up ]
  3. Health-related quality of life (SF-36) [ Time Frame: at baseline and after the 4-6 week endurance training program(before surgery), and at 3 and 6 months follow-up ]
  4. Analysis of the barriers for the use of communication and information technologies in prehabilitation program [ Time Frame: Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024776


Locations
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Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Graciela Martinez Palli Hospital Clinic de Barcelona, IDIBAPS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Graciela Martinez-Palli, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02024776    
Other Study ID Numbers: PI13/00425
PI13/00425 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Graciela Martinez-Palli, Hospital Clinic of Barcelona:
Training
Wellness
Aerobic capacity
Information and communication technology, surgical risk
Abdominal surgery