Coronary Artery DiseaseNCT02375282
Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study
A study testing Ambulation orderly in people with Coronary Artery Disease and Mitral Valve Insufficiency, run by Baystate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Stenosis
- What is being tested?
- Ambulation orderly
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have had a cardiac surgery procedure (coronary artery bypass grafting surgery or valve surgery). Must be ambulatory prior to surgery
Who cannot join
- Unable to consent, cognitively impaired, and patients unable to walk prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Regurgitation, Mitral Valve Stenosis, Coronary Artery Bypass Graft Triple Vessel
- Being tested
- Ambulation orderly
- Keywords
- ambulation, cardiac rehabilitation
- Medical subject headings
- Coronary Artery Disease, Mitral Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulation orderlyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ambulation Orderly Intervention | Experimental | 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. Receives: Procedure: Ambulation orderly |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
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.
Measured: 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 (7)
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.
Measured: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
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.
Measured: 3rd day on M6 as part of study (typically post operative day 6 or 7)
Average Total Daily Energy Expenditure
The patient will wear an accelerometer, which will keep track of the total daily expenditure in calories per day.
Measured: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Average Total Time in Activity
The patient will wear an accelerometer, which will keep track of the total time in activity.
Measured: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
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.
Measured: Each time the 6 minute walk test is done.
Barthel Index
The research staff and nurses or exercise physiologist will complete a survey to assess the physical independence of the patients.
Measured: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
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.
Measured: Following the hospital stay within 2-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Springfield College
- Responsible party
- Sponsor
- Investigators
- Peter Lindenauer, MD, MSc, Study director, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375282
- Sponsor's protocol ID
- BH-14-169
- Status last verified
- Nov 2017
- First submitted
- 27 Jan 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17935241Callen 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.
PubMed 15311196Pashikanti 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.
PubMed 22336934Pack 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.
PubMed 30687584
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT02375282
- Acronym / sponsor ID
- BH-14-169
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Collaborators
- Springfield College
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulation Orderly Intervention | Experimental | Procedure: Ambulation orderlyPatients 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have had a cardiac surgery procedure (coronary artery bypass grafting surgery or valve surgery). Must be ambulatory prior to surgery
Key exclusion criteria (1 listed)
- Unable to consent, cognitively impaired, and patients unable to walk prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulation orderlyThe 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. | Procedure or surgery | Ambulation Orderly Intervention |
Primary outcome
Average Daily Step Counts while on M6 (cardiac surgery general floor.)
Time frame: 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
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
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.
7 secondary outcomes
Average Slope of Progression in Average Total Daily Step Counts
Time frame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Average Daily Step Count on the 3rd day after arrival on M6
Time frame: 3rd day on M6 as part of study (typically post operative day 6 or 7)
Average Total Daily Energy Expenditure
Time frame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Average 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.
Pre and post 6 minute walk test vital signs
Time frame: Each time the 6 minute walk test is done.
Barthel Index
Time frame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
Time frame: Following the hospital stay within 2-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Background: PubMed 17935241Brown 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.
- Background: PubMed 15311196Callen 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.
- Background: PubMed 22336934Pashikanti 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.
- Derived from this study: PubMed 30687584Pack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lindenauer, MD, MSc study director
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulation orderly in people with Coronary Artery Disease and Mitral Valve Insufficiency, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Step Counts while on M6 (cardiac surgery general floor.) (time frame: From arrival on M6 to hospital discharge. This is typically from post operative day 3 until post operative day 9-12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375282, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.