Promotion of Ambulation Before Non-cardiac Surgery

NCT ID: NCT03213496

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2017-12-31

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.

Conditions

Non-cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Walk prescription

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.

Group Type: EXPERIMENTAL

Walk prescription

Intervention Type: BEHAVIORAL

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

Conventional care

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

Group Type: OTHER

Conventional care

Intervention Type: OTHER

Patient do not walk before surgery

Interventions

Walk prescription

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

Intervention Type: BEHAVIORAL

Conventional care

Patient do not walk before surgery

Intervention Type: OTHER

Other Intervention Names

prehabilitation

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Cardioinfantil Instituto de Cardiología

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Cortés, PI

Role: PRINCIPAL_INVESTIGATOR

Fundación Cardioinfantil Instituto de Cardiología

Locations

Fundación CardioInfantil Instituto de Cardiología

Bogotá, Cundinamarca, Colombia

Clinica Carlos Ardila Lulle-FOSCAL

Bucaramanga, Santander Department, Colombia

Countries

Colombia

References

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.

Reference Type: BACKGROUND

PMID: 20602503 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26300015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21878237 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34321092 (View on PubMed)

Other Identifiers

CEIC-2224-2015

Identifier Type: -

Identifier Source: org_study_id