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Completed

NCT Number: NCT03636815

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

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

Completed

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Key information

Conditions

Left Ventricular Assist Device Physical Therapy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University, College of Medicine, Department of Physical Therapy

Taipei, Zhongzheng, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Physical Therapy

Other

Cardiopulmonary rehabilitation for patients who receive left ventricle assist device

Primary outcomes

  1. Change in walking function

    Time frame: 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 outcomes

  1. Change in Rating Perceived Exertion (RPE)

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, two weeks

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Acronym: LVAD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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