Promotion of Ambulation Before Non-cardiac Surgery

Non-cardiac Surgery Clinical Trial

— PAMP-Phase2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213496
• Other study ID #: CEIC-2224-2015
• Status: Completed
• Phase: N/A
• First received: July 5, 2017
• Last updated: March 16, 2018
• Start date: May 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: Fundación Cardioinfantil Instituto de Cardiología
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-cardiac Surgery

Intervention

Behavioral:
• Walk prescription
30-40 minutes daily, for five days at the week, all weeks up to surgery.

Other:
• Conventional care
Patient do not walk before surgery

Locations

Country	Name	City	State
Colombia	Fundación CardioInfantil Instituto de Cardiología	Bogotá	Cundinamarca
Colombia	Clinica Carlos Ardila Lulle-FOSCAL	Bucaramanga	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardioinfantil Instituto de Cardiología

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Total stay hours	Up 40 weeks in hospitalization
Secondary	Falls	Fall event reported in patients´ charts	Up 40 weeks in hospitalization
Secondary	Ischemic events	Myocardial infarction or stroke	Up 40 weeks in hospitalization
Secondary	Time to the first walk	First time out of the bed registered in patients´charts	Up 40 weeks in hospitalization