Promotion of Ambulation Before Non-cardiac Surgery (PAMP-Phase2)

March 16, 2018 updated by: Fundación Cardioinfantil Instituto de Cardiología

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Fundación CardioInfantil Instituto de Cardiología
    • Santander
      • Bucaramanga, Santander, Colombia
        • Clinica Carlos Ardila Lulle-FOSCAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Walk prescription
30-40 minutes daily, for five days at the week, all weeks up to surgery.
Other Names:
  • prehabilitation
Other: Conventional care
Currently patients do not receive exercise (walk)-prescription before non cardiac surgery.
Other: Conventional care
Patient do not walk before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Up 40 weeks in hospitalization
Total stay hours
Up 40 weeks in hospitalization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Cardioinfantil Instituto de Cardiología

Investigators

  • Principal Investigator: Olga Cortés, PI, Fundación CardioInfantil Instituto de Cardiología

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEIC-2224-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be registered in indepenedent filles in folders; and also data will be typed on the PAMP Data base (CARDIECOL). Data can be monitored by a coordinator.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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