Brief Title
Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study
Official Title
Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study
Brief Summary
Ambulation following surgery has been found to be beneficial for patients; however, nurses and doctors struggle with getting post-operative, hospitalized patients to walk on their own. One promising strategy to address this might be an ambulation orderly, an employee whose single responsibility is to assure that patients walk 3-4 times per day. However, the effect of the ambulation orderly on post-operative physical activity has not yet been described. It is important to quantify what the ambulation orderly does in order to assess if this is an effective method for helping patients walk. As a result, the investigators will perform a pilot randomized controlled trial to test the effects of an ambulation orderly in patients hospitalized with recent cardiac surgery. Half of the patients will be assigned to walk with the ambulation orderly 3-4 times/day and the control group will be given standard nursing encouragement and assistance and encouragement to walk. The investigators will evaluate the average total daily step counts (over the hospital course, usually 4-7 days) and the change in walking distance between a baseline and a final 6 minute walk test. The investigators will also evaluate exercise physiologic parameters (heart rate, oxygen saturation) during ambulation, patient functional independence, and patient satisfaction.
Detailed Description
The investigators will perform a prospective randomized controlled trial at Baystate Medical Center, a 684-bed academic teaching hospital that serves as the referral center for a population of approximately 800,000 people living in Western Massachusetts. The responsibility of the ambulation orderly is to walk patients after having a cardiac surgery, such as a coronary artery bypass surgery or a valve replacement or repair. Patients will be randomized to receive visits from the ambulation orderly (ambulation group) or to receive the standard care of Baystate Medical Center (control group). The standard of care will be nurse-directed ambulation, as is currently done in all other nursing floors at Baystate Medical Center. Nurses will be instructed to walk with the patients as they did before the initiation of the ambulation orderly and as they do when the orderly is on vacation, at conferences, training, or away for illness.
Study Type
Interventional
Primary Outcome
Average Daily Step Counts while on M6 (cardiac surgery general floor.)
Secondary Outcome
Average Slope of Progression in Average Total Daily Step Counts
Condition
Coronary Artery Disease
Intervention
Ambulation orderly
Study Arms / Comparison Groups
Ambulation Orderly Intervention
Description: Patients that are in this group are those randomized to receive visits from the ambulation orderly (ambulation group). The patients in this group will receive the visits from the ambulation orderly in addition to the standard of care that occurs with the rest of the hospital and with the control group.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
36
Start Date
March 2015
Completion Date
July 2016
Primary Completion Date
July 2015
Eligibility Criteria
Inclusion Criteria: - Patients who have had a cardiac surgery procedure (coronary artery bypass grafting surgery or valve surgery). Must be ambulatory prior to surgery Exclusion Criteria: - Unable to consent, cognitively impaired, and patients unable to walk prior to surgery
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Peter Lindenauer, MD, MSc, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02375282
Organization ID
BH-14-169
Responsible Party
Sponsor
Study Sponsor
Baystate Medical Center
Collaborators
Springfield College
Study Sponsor
Peter Lindenauer, MD, MSc, Study Director, Baystate Medical Center
Verification Date
November 2017