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

NCT02375282 | Completed

• 1 other identifier: BH-14-169
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  3rd day on M6 as part of study (typically post operative day 6 or 7)

• 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.

• 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.

• Pre and post 6 minute walk test vital signs

  Each time the 6 minute walk test is done.

Study Arms (2)

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.

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.

Interventions

Ambulation orderly 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.

Ambulation Orderly Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baystate Medical Center: lead
• Springfield College: collaborator

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (4)

• 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.

  PMID: 17935241 BACKGROUND

• 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.

  PMID: 15311196 BACKGROUND

• 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.

  PMID: 22336934 BACKGROUND

• 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.

  PMID: 30687584 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Mitral Valve Insufficiency; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• Peter Lindenauer, MD, MSc

  Baystate Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)