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

NCT ID: NCT02375282

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-07-31

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.

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ambulation Orderly Intervention

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.

Group Type: EXPERIMENTAL

Ambulation orderly

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ambulation orderly

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Springfield College

OTHER

Sponsor Role: collaborator

Baystate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Lindenauer, MD, MSc

Role: STUDY_DIRECTOR

Baystate Medical Center

Locations

Baystate Medical Center

Springfield, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17935241 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15311196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22336934 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30687584 (View on PubMed)

Other Identifiers

BH-14-169

Identifier Type: -

Identifier Source: org_study_id