Promotion of Ambulation Before Non-cardiac Surgery

Not Applicable

Completed

• Conditions: Non-cardiac Surgery
• Interventions: Other: Conventional care; Behavioral: Walk prescription

• Registration Number: NCT03213496
• Lead Sponsor: Fundación Cardioinfantil Instituto de Cardiología

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.

Study Timeline

• Study Start: 2016-05-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional care	Conventional care	Currently patients do not receive exercise (walk)-prescription before non cardiac surgery.
Walk prescription	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.

Primary Outcome Measures

Name	Time	Method
Length of stay	Up 40 weeks in hospitalization	Total stay hours

Secondary Outcome Measures

Name	Time	Method
Falls	Up 40 weeks in hospitalization	Fall event reported in patients´ charts
Ischemic events	Up 40 weeks in hospitalization	Myocardial infarction or stroke
Time to the first walk	Up 40 weeks in hospitalization	First time out of the bed registered in patients´charts

Trial Locations

Locations (2)

Fundación CardioInfantil Instituto de Cardiología; 🇨🇴 Bogotá, Cundinamarca, Colombia

Clinica Carlos Ardila Lulle-FOSCAL; 🇨🇴 Bucaramanga, Santander, Colombia