Clinical trial NCT02375282: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Mitral Valve Insufficiency
Aortic Valve Stenosis
Aortic Valve Regurgitation
Mitral Valve Stenosis
Coronary Artery Bypass Graft Triple Vessel
Keywords: ambulation
cardiac rehabilitation
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: Springfield College
First posted: 2015-03-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average Daily Step Counts while on M6 (cardiac surgery general floor.)
timeFrame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
measure: Average change in walking distance between baseline and final 6-minute walk
timeFrame: From arrival on M6 (baseline) to hospital discharge (final). This is typically from post operative day 3 until post operative day 9-12
Secondary outcomes:
measure: Average Slope of Progression in Average Total Daily Step Counts
timeFrame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
measure: Average Daily Step Count on the 3rd day after arrival on M6
timeFrame: 3rd day on M6 as part of study (typically post operative day 6 or 7)
measure: Average Total Daily Energy Expenditure
timeFrame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
measure: Average Total Time in Activity
timeFrame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
measure: Pre and post 6 minute walk test vital signs
timeFrame: Each time the 6 minute walk test is done.
measure: Barthel Index
timeFrame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
measure: Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
timeFrame: Following the hospital stay within 2-6 weeks
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Peter Lindenauer, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Brown CJ, Williams BR, Woodby LL, Davis LL, Allman RM. Barriers to mobility during hospitalization from the perspectives of older patients and their nurses and physicians. J Hosp Med. 2007 Sep;2(5):305-13. doi: 10.1002/jhm.209.
citation: Callen BL, Mahoney JE, Grieves CB, Wells TJ, Enloe M. Frequency of hallway ambulation by hospitalized older adults on medical units of an academic hospital. Geriatr Nurs. 2004 Jul-Aug;25(4):212-7. doi: 10.1016/j.gerinurse.2004.06.016.
citation: Pashikanti L, Von Ah D. Impact of early mobilization protocol on the medical-surgical inpatient population: an integrated review of literature. Clin Nurse Spec. 2012 Mar-Apr;26(2):87-94. doi: 10.1097/NUR.0b013e31824590e6.
citation: Pack QR, Woodbury EA, Headley S, Visintainer P, Engelman R, Miller A, Riley H, Lagu T, Lindenauer PK. Ambulation Orderlies and Recovery After Cardiac Surgery: A Pilot Randomized Controlled Trial. J Clin Exerc Physiol. 2017 Sep;6(3):42-49. doi: 10.31189/2165-6193-6.3.42.