Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04575220 |
Other study ID # |
58756 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 20, 2020 |
Est. completion date |
March 2, 2022 |
Study information
Verified date |
June 2023 |
Source |
University of Kentucky |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this pilot study is to determine if a home based bicycle exercise program can
significantly improve the exercise tolerance and well being of pulmonary outpatients. The
investigators will use a computer based monitoring system to allow us to speak with
participants, view participants, and track patient bicycle activity (speed, duration of
exercise, rate of work) during exercise sessions. The investigators plan to have participants
perform three telemonitored exercise sessions per week for 12 weeks as part of this program.
The investigators will assess exercise performance on the bicycle, called a work rate test,
at the beginning of the program and then again at 6 weeks and 12 weeks into the program to
determine if the program can produce a clinically significant improvement in work rate test
performance (i.e. a greater than 1.15 minute increase in exercise duration at an 80% work
rate). The investigators will also assess participant CRQ, SPPB scores and SF36 scores
(indices of patient well being) at baseline, at 6 weeks, and at 12 weeks, to determine if the
exercise program elicits an increase in these indices.
Description:
Studies have shown that pulmonary rehabilitation, which includes exercise and patient
education, is a valuable therapy for patients with pulmonary diseases. In fact, pulmonary
rehabilitation delivered soon after patient discharge is known to produce a major improvement
in patient outcomes. Specifically, studies have shown this intervention reduces readmission
rates by 30-70% over the next year. In addition, this therapy improves exercise tolerance,
performance of tasks of daily living and sense of patient well being. One study even shows
this therapy is 30 times as effective as bronchodilator therapy in improving patient
outcomes.
Surprisingly, however, very few pulmonary patients receive pulmonary rehabilitation. Recent
studies have shown that 94-98% of discharged pulmonary patients fail to receive this therapy.
This pattern has been shown to exist across the United States, with no state demonstrating a
much larger use of this therapy. Moreover, use of this therapy is even worse for minorities
(only 1% receive pulmonary rehabilitation) and rural populations, such as patients in
southern and eastern Kentucky. Several factors are responsible for this failure to employ
pulmonary rehabilitation including: (a) very few centers are available and patients cannot
realistically travel to the existing centers because of distance, (b) this form of
rehabilitation is expensive and patients must pay a large copay (30-50 dollars per session,
adding up to a total of 1800 dollars for a typical 12 week program) which many patients
cannot afford, (c) centers are only open for restricted hours and working patients cannot
miss work to go for rehabilitation, and (d) patients are only eligible for 36 treatment
sessions for life.
The purpose of the present project is to define a new home based exercise program that should
provide exercise training as good or better than conventional brick and mortar rehabilitation
programs. The investigators will use technological advances in home based exercise equipment
to both precisely measure participant exercise and to assess physiological improvements over
time. This technology will also reduce the expense required to supervise participant
training, dramatically reducing costs compared to conventional center based programs. In
addition, because programs are home based, the investigators can provide access to
participants in rural locations, reduce travel, and easily extend the convenience and
schedule of training sessions to accommodate participant lifestyles. While recently there
have been a few attempts to provide home based pulmonary rehabilitation programs (e.g. by VA
rural health, the Southern Alabama consortium) these other programs do not provide the
intensity of training possible with the new paradigm in the current project, are not proven
to have the same beneficial effects as conventional center based rehabilitation, and have
higher personnel costs making long term financial viability uncertain.