NCT03636815

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

August 1, 2018

Last Update Submit

September 24, 2019

Conditions

Keywords

Left ventricular assist devicePhysical therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Rating Perceived Exertion (RPE)

    Baseline, two weeks

  • Change in heart rate

    Baseline, two weeks

  • Change in blood pressure

    Baseline, two weeks

Interventions

Cardiopulmonary rehabilitation for patients who receive left ventricle assist device

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are diagnosed with heart failure, need left ventricular assist device intervention, and received physical therapy intervention

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, Zhongzheng, 100, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 22425235BACKGROUND
  • 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.

    PMID: 25447348BACKGROUND
  • 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.

    PMID: 20571404BACKGROUND

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 17, 2018

Study Start

April 8, 2018

Primary Completion

March 8, 2019

Study Completion

March 8, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations