Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Coronary Artery Bypass Graft Triple Vessel; Coronary Artery Disease; Mitral Valve Insufficiency; Aortic Valve Regurgitation; Mitral Valve Stenosis
• Interventions: Procedure: Ambulation orderly

• Registration Number: NCT02375282
• Lead Sponsor: Baystate Medical Center

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 Timeline

• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-02
• Primary Completion: 2015-07
• Study Completion: 2016-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients who have had a cardiac surgery procedure (coronary artery bypass grafting surgery or valve surgery). Must be ambulatory prior to surgery

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Exclusion Criteria

• Unable to consent, cognitively impaired, and patients unable to walk prior to surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambulation Orderly Intervention	Ambulation orderly	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.

Primary Outcome Measures

Name	Time	Method
Average Daily Step Counts while on M6 (cardiac surgery general floor.)	From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.	The patient will wear an accelerometer, which will keep track of the amount of steps the patient took each day over the course of the hospitalization.
Average change in walking distance between baseline and final 6-minute walk	From arrival on M6 (baseline) to hospital discharge (final). This is typically from post operative day 3 until post operative day 9-12	Each patient will complete a 6 minute walk after arriving on M6 (from intensive care until) and again at hospital discharge. The difference in distance walked will be compared.

Secondary Outcome Measures

Name	Time	Method
Average Slope of Progression in Average Total Daily Step Counts	From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.	The patient will wear an accelerometer, which will keep track of the amount of steps the patient took each day. The progression between groups will be compared.
Average Daily Step Count on the 3rd day after arrival on M6	3rd day on M6 as part of study (typically post operative day 6 or 7)	The step counts on the 3rd day after arrival on M6 will be compared in all groups. All patients are expected to still be in the hospital at this time.
Average Total Daily Energy Expenditure	From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.	The patient will wear an accelerometer, which will keep track of the total daily expenditure in calories per day.
Average Total Time in Activity	From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.	The patient will wear an accelerometer, which will keep track of the total time in activity.
Pre and post 6 minute walk test vital signs	Each time the 6 minute walk test is done.	Heart rate, oxygen saturation, rating of perceived exertion, and rating of dyspnea will be measured before and after each 6 minute walk test.
Barthel Index	From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.	The research staff and nurses or exercise physiologist will complete a survey to assess the physical independence of the patients.
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey	Following the hospital stay within 2-6 weeks	The HCAHPS survey will be given to each patient at discharge to mail back to assess the overall satisfaction in each group.

Trial Locations

Locations (1)

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States