Physical Therapy Clinical Trial
— LVADOfficial title:
The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device (LVAD) on Physical Function
NCT number | NCT03636815 |
Other study ID # | 201803106RIND |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 8, 2018 |
Est. completion date | March 8, 2019 |
Verified date | September 2019 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University, College of Medicine, Department of Physical Therapy | Taipei | Zhongzheng |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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
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 |
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