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

Completed

• Conditions: Left Ventricular Assist Device; Physical Therapy

• Registration Number: NCT03636815
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2018-04-08
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Primary Completion: 2019-03-08
• Study Completion: 2019-03-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in walking function	Baseline, two weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in heart rate	Baseline, two weeks	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.
Change in blood pressure	Baseline, two weeks	Resting blood pressure and blood pressure after 6MWT will be measured.
Change in Rating Perceived Exertion (RPE)	Baseline, two weeks	By using the Borg Rating of Perceived Exertion Scale (score 6-20), the patient subjectively grade the level of perceived exertion after 6MWT.

Trial Locations

Locations (1)

National Taiwan University, College of Medicine, Department of Physical Therapy; 🇨🇳 Taipei, Zhongzheng, Taiwan