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Promotion of Ambulation Before Non-cardiac Surgery

NCT03213496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2018-03-20

No results posted yet for this study

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

Conditions

  • Non-cardiac Surgery

Interventions

BEHAVIORAL

Walk prescription

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

OTHER

Conventional care

Patient do not walk before surgery

Sponsors & Collaborators

  • Fundación Cardioinfantil Instituto de Cardiología

    lead OTHER

Principal Investigators

  • Olga Cortés, PI · Fundación Cardioinfantil Instituto de Cardiología

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03213496 on ClinicalTrials.gov