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

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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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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

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.

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Average Slope of Progression in Average Total Daily Step Counts

Condition

Coronary Artery Disease

Intervention

Ambulation orderly

Study Arms / Comparison Groups

 Ambulation Orderly Intervention
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

36

Start Date

March 2015

Completion Date

July 2016

Primary Completion Date

July 2015

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter Lindenauer, MD, MSc, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02375282

Organization ID

BH-14-169

Responsible Party

Sponsor

Study Sponsor

Baystate Medical Center

Collaborators

 Springfield College

Study Sponsor

Peter Lindenauer, MD, MSc, Study Director, Baystate Medical Center

Verification Date

November 2017