The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device on Physical Function

Physical Therapy Clinical Trial

— LVAD  

Official title:

The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device (LVAD) on Physical Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636815
• Other study ID #: 201803106RIND
• Status: Completed
• Start date: April 8, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: September 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To retrospectively investigate the effect of physical therapy intervention on improving physical function of patients post left ventricular assist device (LVAD) through electronic medical record survey

Description:

Method: Using portable electronic medical record system in National Taiwan University Hospital (NTUH), retrospectively survey medical record of patients who underwent left ventricular assist device (LVAD) operation in NTUH, compare improvement among those who had received physical therapy intervention and those who hadn't.

Inclusion criteria: aged older than 20 years old; diagnosed with heart failure and need LVAD implantation

Progress: Note down patients' clinical signs and symptoms, drug usage, imaging findings, physical therapy intervention details, and recovery of functional status. Physical therapy intervention details include: onset symptoms, history, treatment frequency, treatment type, any signs and symptoms during treatment progress and recovery of functional status post physical therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with heart failure, need left ventricular assist device intervention

• Over 20 years old

• Received physical therapy intervention

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Left Ventricular Assist Device
• Physical Therapy

Intervention

Other:
• physical therapy
Cardiopulmonary rehabilitation for patients who receive left ventricle assist device

Locations

Country	Name	City	State
Taiwan	National Taiwan University, College of Medicine, Department of Physical Therapy	Taipei	Zhongzheng

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Hayes K, Leet AS, Bradley SJ, Holland AE. Effects of exercise training on exercise capacity and quality of life in patients with a left ventricular assist device: a preliminary randomized controlled trial. J Heart Lung Transplant. 2012 Jul;31(7):729-34. doi: 10.1016/j.healun.2012.02.021. Epub 2012 Mar 14. — View Citation

Kerrigan DJ, Williams CT, Ehrman JK, Saval MA, Bronsteen K, Schairer JR, Swaffer M, Brawner CA, Lanfear DE, Selektor Y, Velez M, Tita C, Keteyian SJ. Cardiac rehabilitation improves functional capacity and patient-reported health status in patients with continuous-flow left ventricular assist devices: the Rehab-VAD randomized controlled trial. JACC Heart Fail. 2014 Dec;2(6):653-9. doi: 10.1016/j.jchf.2014.06.011. Epub 2014 Oct 22. — View Citation

Laoutaris ID, Dritsas A, Adamopoulos S, Manginas A, Gouziouta A, Kallistratos MS, Koulopoulou M, Voudris V, Cokkinos DV, Sfirakis P. Benefits of physical training on exercise capacity, inspiratory muscle function, and quality of life in patients with ventricular assist devices long-term postimplantation. Eur J Cardiovasc Prev Rehabil. 2011 Feb;18(1):33-40. doi: 10.1097/HJR.0b013e32833c0320. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in walking function	By using Six-Minute Walk Test (6MWT), we can obtain the maximum distance that patient can afford walking. In 6 minutes, they should walk as many as they can, on a 15-meter level corridor, assisted device (e.g. cane) can be used if they need. During the test, the patient can stop or rest if they want.	Baseline, two weeks
Secondary	Change in Rating Perceived Exertion (RPE)	By using the Borg Rating of Perceived Exertion Scale (score 6-20), the patient subjectively grade the level of perceived exertion after 6MWT.	Baseline, two weeks
Secondary	Change in heart rate	While doing 6MWT, patients' heart rate will be monitored through portable electrocardiography (ECG) throughout the test. Resting heart rate and heart rate after 6MWT will be recorded.	Baseline, two weeks
Secondary	Change in blood pressure	Resting blood pressure and blood pressure after 6MWT will be measured.	Baseline, two weeks

External Links

•   National Taiwan University Hospital, Department of Cardiovascular Surgery