Adaptive Home Based Pulmonary Tele-exercise
Condition: Rehabilitation
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): 12 weeks of bicycle exercise
Intervention type(s): Other
Intervention description(s): Subjects will conduct monitored exercise, three sessions per week for 12 weeks.
Intervention model: Single Group Assignment
Intervention model description: Single arm pilot study evaluating fitness before and after home based rehabilitation
Masking: None (Open Label)
Primary purpose: Treatment