High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Several animal and human epidemiologic studies have provided evidence that exercise may be
      neuroprotective in Parkinson's disease (PD). Exercise may forestall diagnosis and, in the
      case of those who have already been diagnosed with PD, it may slow the observed
      neurodegeneration. Unfortunately, because this line of research is in early stages, there is
      little evidence to indicate what biological mechanisms underlie the neuroprotection that is
      conferred with exercise. Toward this end, it is possible that an interaction between
      endogenous antioxidant enzymes, inflammatory processes, and reactive oxygen species may be
      associated with exercise improvements in PD.

      One of the most common reasons for premature death in PD is falls. Several meta-analyses have
      concluded that exercise training programs focused on balance and/or strength training are
      effective at improving aspects of balance. Taken together, the current body of evidence
      suggests that exercise may be neuroprotective and balance/strength training may decrease the
      likelihood of a fall. The combination of these efficacious treatment modalities (exercise and
      balance/strength training) in a comprehensive treatment approach to improve PD symptoms and
      balance has been previously reported at relatively mild or moderate exercise intensities.
      Because recent research has suggested that patients with PD may benefit more from more
      physically intense programs, we are proposing a more aggressive approach with regard to
      exercise intensity and frequency in the present trial. The primary purpose of this study is
      to determine the feasibility and safety of a high intensity exercise approach to PD. A
      secondary purpose is to determine the trajectory of change in outcomes over the duration of
      the trial from a high intensity fall prevention program. It is hoped that a signal of
      efficacy will allow this trial to progress to a comparative effectiveness trial. An important
      innovative design element is collecting biological assays to better understand the mechanism
      underlying the anticipated clinical improvements.

      Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp
      (HIBC) in patients with PD by analyzing adherence and whether they achieve minimum Centers
      for Disease Control exercise standards (150 min/wk moderate level aerobic exercise;
      strengthening at least two times per week) for the duration of the trial. Aim 2 is to
      determine if participation in an 8-week HIBC under the direction of a physical therapist is
      safe for individuals with PD. Secondary Aim 3 is to determine if participation in an 8-week
      HIBC will produce a signal of efficacy for several physical outcomes: falls per physical
      activity ratio, balance efficacy, motor activity, fatigue, muscle strength, bone health,
      cognition/mood, and quality of life. Secondary Aim 4 is to determine if participation in an
      8-week HIBC will produce a signal of efficacy for biological outcomes, anti-inflammatory
      cytokines and anti-oxidant enzymes. An additional exploratory aim will be an analysis of BDNF
      val66val, val66met, met66met polymorphisms to determine if there is a differential response
      to exercise.

      This trial is innovative because it utilizes a high intensity comprehensive exercise
      treatment approach (aerobic exercise, strengthening, and balance training). To our knowledge,
      there have been no trials of individuals with PD who have participated in a trial of this
      intensity in a group "boot camp" setting. Another innovative design element is the use of
      three novel assessments: biological assays of pro- and anti-inflammatory cytokines,
      endogenous anti-oxidant enzymes and a novel assessment of falls (falls per physical activity
      ratio).

      Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual
      care control group (standard, low intensity group therapy class) under the direction of
      physical therapists. Each group will have 15 participants with a 1:5 patient-to-therapist
      ratio. The HIBC will be 1.5 hours daily, Monday through Friday. Participants will be required
      to attend 3 out of the 5 days. The protocol of the HIBC will include the following exercise
      components: A. 30 minutes of moderate-high intensity aerobic exercise; B. 15 minutes of
      strengthening the major muscle groups; C. 15 minutes of balance training; and, D. 15 minutes
      of interspersed rest and stretching. Participants will rotate through these four exercise
      components. Participants will have one baseline test and assessments at the 2-week, 4 week,
      8-week, and 6-month points. Outcomes of the primary aims (Aim 1 and Aim 2) will be frequency
      counts of participation, adverse events, and compliance with exercise. The outcomes for the
      secondary aims will include measures of balance and falls, physical capacity, fatigue,
      exercise/physical activity behavior, and biological assays.
    


Intervention name(s): High intensity exercise and balance training; Usual care arm exercise
Intervention type(s): Other; Other
Other intervention name(s): A. 30 minutes of moderate-high intensity aerobic exercise at 70%+ of estimated maximum heart rate; B. 15 minutes of strengthening the major muscle groups of the trunk and upper/lower extremities; C. 15 minutes of balance training; D. 15 minutes of rest and stretching; 10 minutes of stretching; 10 minutes of aerobic exercise (60% of heart rate maximum); 10 minutes of strengthening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: boot camp; exercise; balance training; fall prevention; falling; strength training