Clinical trial NCT03213496: Promotion of Ambulation Before Non-cardiac Surgery
Official title: Impact of a Routine of Pre-surgical Walk for Non Cardiac Adult Patients Compared to Conventional Intervention (Not Recommended Exercise) in Reducing the Length of Hospital Stay and the Time of Onset of Ambulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-cardiac Surgery
Keywords: clinical trial, non cardiac surgery, walking.
Lead sponsor: Fundación Cardioinfantil Instituto de Cardiología
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 368
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adult patients programmed for elective non-cardiac surgery, prior informed consent, will be randomized to an intervention (prescription of a programed walking) in the period of 2-3 weeks before surgery or will be assigned to a control group/conventional care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to conventional intervention (not recommended exercise) in reducing the length of hospital stay and the time of onset of ambulation during postoperative hospitalization, in patients with ability to move, ≥30 years who will undergo non-cardiac surgery.

Secondary

1. Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during hospitalization.
2. Evaluate the incidence of falls during hospitalization.

Methodology The PAMP project phase II, as a component of CARDIECOL program will be implemented by designing a pilot study, a randomized controlled trial. Adult-patients with greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed consent will be randomized to an intervention prescribed of walking in the period of 2-3 weeks before surgery or will be assigned to a Control group/conventional care. The study was not blinded to patients, but evaluation and analysis of the data will be blinded for researchers and statisticians. Patients will be evaluated on their previous level of physical activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise). This study will include a sample of 500 patients, with capacity to mobilize, ability to walk at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of stay, and time to first walk. Other results are evaluation falls during hospitalization and the presence of falls, report of cardiovascular events, and death by group.

Expected results

Detailed description: Randomization was planned to be performed one to five weeks before non-cardiac surgery for all eligible patients, once they have decided to participate in the study. It was performed on a random computed to an intervention group (Walk prescription); or conventional care group (no exercise) in a 2:1 relation respectively. Intervention and Management Processes The pre surgical intervention walk routine is defined of at least 150-300 minutes of walk before going into surgery.

Analysis will be following the principle of intention to treat. A description of categorical and quantitative demographic data will be performed. Evaluation will also include the mean difference in the length of hospital stay for each of the groups and standard deviation, given a confidence interval of 95%. An analysis of the time of occurrence of the first walk using the Kaplan-Meier estimator will be performed.

Eligibility criteria: Inclusion Criteria:

* undergoing non-cardiac surgery
* general anesthesia or epidural or spinal anesthesia
* age ≥ 30 years
* able to walk and communicate

Exclusion Criteria:

* having any alteration of their state of consciousness
* altered mental status and communication

Primary outcomes:
measure: Length of stay
timeFrame: Up 40 weeks in hospitalization
Secondary outcomes:
measure: Falls
timeFrame: Up 40 weeks in hospitalization
measure: Ischemic events
timeFrame: Up 40 weeks in hospitalization
measure: Time to the first walk
timeFrame: Up 40 weeks in hospitalization
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación CardioInfantil Instituto de Cardiología
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Clinica Carlos Ardila Lulle-FOSCAL
state: Santander
Study officials:
affiliation: Fundación Cardioinfantil Instituto de Cardiología
name: Olga Cortés, PI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
citation: Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966-9. doi: 10.1139/apnm-2015-0084. Epub 2015 May 13.
citation: Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
citation: Cortes OL, Herrera-Galindo M, Becerra C, Rincon-Roncancio M, Povea-Combariza C, Esparza-Bohorquez M. Preoperative walking recommendation for non-cardiac surgery patients to reduce the length of hospital stay: a randomized control trial. BMC Sports Sci Med Rehabil. 2021 Jul 28;13(1):80. doi: 10.1186/s13102-021-00317-w.