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Completed

NCT Number: NCT03213496

Promotion of Ambulation Before Non-cardiac Surgery

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

Completed

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Key information

Conditions

Non-cardiac Surgery

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación CardioInfantil Instituto de Cardiología, Bogotá, Cundinamarca, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk prescription

Behavioral

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

Other names: prehabilitation

Conventional care

Other

Patient do not walk before surgery

Primary outcomes

  1. Length of stay

    Time frame: Up 40 weeks in hospitalization

    Total stay hours

Secondary outcomes

  1. Falls

    Time frame: Up 40 weeks in hospitalization

    Fall event reported in patients´ charts

  2. Ischemic events

    Time frame: Up 40 weeks in hospitalization

    Myocardial infarction or stroke

  3. Time to the first walk

    Time frame: Up 40 weeks in hospitalization

    First time out of the bed registered in patients´charts

Sponsors and collaborators

Lead sponsor

Fundación Cardioinfantil Instituto de Cardiología

Other

Registry information

Official study 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.

Acronym: PAMP-Phase2

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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