Clinical trial NCT03636815: The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device on Physical Function
Official title: The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device (LVAD) on Physical Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Assist Device
Physical Therapy
Keywords: Left ventricular assist device
Physical therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with heart failure, need left ventricular assist device intervention, and received physical therapy intervention

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with heart failure, need left ventricular assist device intervention
* Over 20 years old
* Received physical therapy intervention

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in walking function
timeFrame: Baseline, two weeks
Secondary outcomes:
measure: Change in Rating Perceived Exertion (RPE)
timeFrame: Baseline, two weeks
measure: Change in heart rate
timeFrame: Baseline, two weeks
measure: Change in blood pressure
timeFrame: Baseline, two weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University, College of Medicine, Department of Physical Therapy
state: Zhongzheng
Study officials:
References:
citation: 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.
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.
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.