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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03636815
Collaborator
(none)
62
1
11
5.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: physical therapy

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 Design

Study Type:
Observational
Actual Enrollment :
62 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device (LVAD) on Physical Function
Actual Study Start Date :
Apr 8, 2018
Actual Primary Completion Date :
Mar 8, 2019
Actual Study Completion Date :
Mar 8, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. Change in blood pressure [Baseline, two weeks]

    Resting blood pressure and blood pressure after 6MWT will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosed with heart failure, need left ventricular assist device intervention

  • Over 20 years old

  • Received physical therapy intervention

Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University, College of Medicine, Department of Physical Therapy Taipei Zhongzheng Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03636815
Other Study ID Numbers:
  • 201803106RIND
First Posted:
Aug 17, 2018
Last Update Posted:
Sep 25, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital

Study Results

No Results Posted as of Sep 25, 2019