Promotion of Ambulation Before Non-cardiac Surgery

NCT03213496 | Completed DMC

• 1 other identifier: CEIC-2224-2015
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 2

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

Conditions

Non-cardiac Surgery

Keywords

clinical trial, non cardiac surgery, walking.

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Total stay hours

  Up 40 weeks in hospitalization

Secondary Outcomes (3)

• Falls

  Up 40 weeks in hospitalization

• Ischemic events

  Up 40 weeks in hospitalization

• Time to the first walk

  Up 40 weeks in hospitalization

Study Arms (2)

Walk prescription

EXPERIMENTAL

Walk prescription for all weeks before non-cardiac surgery. Duration of walk must be of 30-40 minutes every day for five days at the week or until complete 150 minutes at the week, for all weeks up to the surgery.

Behavioral: Walk prescription

Conventional care

OTHER

Currently patients do not receive exercise (walk)-prescription before non cardiac surgery.

Other: Conventional care

Interventions

Walk prescription BEHAVIORAL

30-40 minutes daily, for five days at the week, all weeks up to surgery.

Also known as: prehabilitation

Walk prescription

Conventional care OTHER

Patient do not walk before surgery

Conventional care

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Cardioinfantil Instituto de Cardiología: lead

Study Sites (2)

Fundación CardioInfantil Instituto de Cardiología

Bogotá, Cundinamarca, Colombia

Location

Clinica Carlos Ardila Lulle-FOSCAL

Bucaramanga, Santander Department, Colombia

Location

Related Publications (4)

• 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.

  PMID: 20602503 BACKGROUND

• 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.

  PMID: 26300015 BACKGROUND

• 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.

  PMID: 21878237 BACKGROUND

• 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.

  PMID: 34321092 DERIVED

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Olga Cortés, PI

  Fundación Cardioinfantil Instituto de Cardiología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data of outcomes will be evaluated by statisticians.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: May 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 20, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)