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

Primary Purpose

Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambulation orderly
Sponsored by
Baystate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring ambulation, cardiac rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baystate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ambulation Orderly Intervention

Control Group

Arm 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.

This is for the patients who are randomized to receive the standard care of Baystate Medical Center. 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. These patients will not receive visits from the ambulation orderly.

Outcomes

Primary Outcome Measures

Average Daily Step Counts while on M6 (cardiac surgery general floor.)
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
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

Average Slope of Progression in Average Total Daily Step Counts
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
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
The patient will wear an accelerometer, which will keep track of the total daily expenditure in calories per day.
Average Total Time in Activity
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
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
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
The HCAHPS survey will be given to each patient at discharge to mail back to assess the overall satisfaction in each group.

Full Information

First Posted
January 27, 2015
Last Updated
November 1, 2017
Sponsor
Baystate Medical Center
Collaborators
Springfield College
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1. Study Identification

Unique Protocol Identification Number
NCT02375282
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baystate Medical Center
Collaborators
Springfield College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambulation Orderly Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This is for the patients who are randomized to receive the standard care of Baystate Medical Center. 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. These patients will not receive visits from the ambulation orderly.
Intervention Type
Procedure
Intervention Name(s)
Ambulation orderly
Intervention Description
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 surgery. Baystate Medical Center hired an ambulation orderly May 8, 2013. The ambulation orderly is generally a high school graduate with some training in safe lifting and exercise, but extensive training is not required. In general, the goal is to have 1 ambulation orderly present 7 days a week for 8 hr per day. When available, ambulation orderlies are responsible for walking the patients who have been cleared by the clinical exercise physiologist or nurse up to 4 times per day. The walking of the patients occurs through the halls of the 6th floor of the Mass Mutual wing of Baystate Medical Center.
Primary Outcome Measure Information:
Title
Average Daily Step Counts while on M6 (cardiac surgery general floor.)
Description
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.
Time Frame
From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Title
Average change in walking distance between baseline and final 6-minute walk
Description
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.
Time Frame
From arrival on M6 (baseline) to hospital discharge (final). This is typically from post operative day 3 until post operative day 9-12
Secondary Outcome Measure Information:
Title
Average Slope of Progression in Average Total Daily Step Counts
Description
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.
Time Frame
From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Title
Average Daily Step Count on the 3rd day after arrival on M6
Description
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.
Time Frame
3rd day on M6 as part of study (typically post operative day 6 or 7)
Title
Average Total Daily Energy Expenditure
Description
The patient will wear an accelerometer, which will keep track of the total daily expenditure in calories per day.
Time Frame
From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Title
Average Total Time in Activity
Description
The patient will wear an accelerometer, which will keep track of the total time in activity.
Time Frame
From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Title
Pre and post 6 minute walk test vital signs
Description
Heart rate, oxygen saturation, rating of perceived exertion, and rating of dyspnea will be measured before and after each 6 minute walk test.
Time Frame
Each time the 6 minute walk test is done.
Title
Barthel Index
Description
The research staff and nurses or exercise physiologist will complete a survey to assess the physical independence of the patients.
Time Frame
From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Title
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
Description
The HCAHPS survey will be given to each patient at discharge to mail back to assess the overall satisfaction in each group.
Time Frame
Following the hospital stay within 2-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lindenauer, MD, MSc
Organizational Affiliation
Baystate Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17935241
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.
Results Reference
background
PubMed Identifier
15311196
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.
Results Reference
background
PubMed Identifier
22336934
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.
Results Reference
background
PubMed Identifier
30687584
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.
Results Reference
derived

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

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