Left Ventricular Assist DeviceLVADNCT03636815
The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device on Physical Function
An observational study of Left Ventricular Assist Device and Physical Therapy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Left Ventricular Assist Device, Physical Therapy
- What is being tested?
- physical therapy
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2018to 8 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with heart failure, need left ventricular assist device intervention, and received physical therapy intervention
Who may be able to join
- Diagnosed with heart failure, need left ventricular assist device intervention
- Over 20 years old
- Received physical therapy intervention
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University, College of Medicine, Department of Physical Therapy
Taipei, Zhongzheng, 100
About this study
Official title: The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device (LVAD) 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
Read the 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.
- Conditions
- Left Ventricular Assist Device, Physical Therapy
- Being tested
- physical therapy
- Keywords
- Left ventricular assist device, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
Cardiopulmonary rehabilitation for patients who receive left ventricle assist device
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, two weeks
Secondary outcomes (3)
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.
Measured: Baseline, two weeks
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.
Measured: Baseline, two weeks
Change in blood pressure
Resting blood pressure and blood pressure after 6MWT will be measured.
Measured: Baseline, two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start8 Apr 2018
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Assist DeviceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636815
- Sponsor's protocol ID
- 201803106RIND
- Acronym
- LVAD
- Status last verified
- Sep 2019
- First submitted
- 1 Aug 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22425235Kerrigan 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.
PubMed 25447348Laoutaris 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.
PubMed 20571404
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device (LVAD) on Physical Function
- ClinicalTrials.gov ID
- NCT03636815
- Acronym / sponsor ID
- LVAD / 201803106RIND
- Conditions
- Left Ventricular Assist Device, Physical Therapy
- Keywords
- Left ventricular assist device, Physical therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with heart failure, need left ventricular assist device intervention, and received physical therapy intervention
Key inclusion criteria (3 listed)
- Diagnosed with heart failure, need left ventricular assist device intervention
- Over 20 years old
- Received physical therapy intervention
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapyCardiopulmonary rehabilitation for patients who receive left ventricle assist device | Other | – |
Primary outcome
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.
3 secondary outcomes
Change in Rating Perceived Exertion (RPE)
Time frame: Baseline, two weeks
Change in heart rate
Time frame: Baseline, two weeks
Change in blood pressure
Time frame: Baseline, two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 22425235Hayes 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.
- Background: PubMed 25447348Kerrigan 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.
- Background: PubMed 20571404Laoutaris 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.
- National Taiwan University Hospital, Department of Cardiovascular SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Assist Device and Physical Therapy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking function (time frame: Baseline, two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03636815, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.