Non-cardiac Surgery Clinical Trial
Official 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.
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
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.
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