Clinical trial NCT02230267: High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease
Official title: High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: boot camp
exercise
balance training
fall prevention
falling
strength training
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 27
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Neurologist-diagnosed idiopathic PD based on the UK PD brain bank criteria
* Aged 45-85
* Hoehn and Yahr stages 1-3 (mild to moderate PD)
* Participants do not anticipate a change in medication or surgical procedures in the next 8 months of the trial (2 months for the trial and 6 for the follow-up)
* Clearance from primary care physician to participate in the trial
* Must be stable on PD medication and DBS for 3 months prior to trial

Exclusion Criteria:

* Poorly controlled or unstable cardiovascular disease that precludes participation in exercise
* Moderate-to-severe dementia using the Montreal Cognitive Assessment (MoCA). We will exclude participants with a MoCA cut off score of \<26/30. This cut off value has excellent sensitivity (90%) and specificity (75%).
* Inability to stand or walk for more than 10 minutes
* Other significant disorders that would limit endurance exercise participation (i.e., osteoarthritis, stroke, respiratory problems, traumatic brain injury, neuromuscular disease, pain)
* Already participating in a regular, vigorous exercise program (3X/week or more of \>60% estimated maximum heart rate)
* Participants will be excluded from the trial if they are taking any medications that interfere with heart rate response to exercise

Primary outcomes:
measure: Frequency feasibility
timeFrame: After completion of the 8 week trial
measure: Aerobic feasibility
timeFrame: At the end of the 8 week trial
measure: Strength feasibility
timeFrame: At the end of the 8 week trial
measure: Compliance
timeFrame: At the end of the 8 week trial
measure: Safety
timeFrame: Ongoing throughout the 8 week trial
measure: Motivation
timeFrame: At 8 weeks
measure: Falls
timeFrame: At the end of the 8 week trial
Secondary outcomes:
measure: Falls
timeFrame: up to 6 months
measure: Motor activity
timeFrame: up to 6 months
measure: Fatigue
timeFrame: up to 6 months
measure: Strength
timeFrame: up to 6 months
measure: Cognition
timeFrame: up to 6 months
measure: Quality of life
timeFrame: up to 6 months
measure: Long term behavioral change
timeFrame: up to 6 months
measure: mini-Balance Evaluation Systems Test (mini-BESTest)
timeFrame: up to 6 months
measure: Falls self-efficacy
timeFrame: up to 6 months
measure: Fall Efficacy
timeFrame: Up to 6 months
measure: Fall catastrophization
timeFrame: Up to 6 months
measure: Physical activity
timeFrame: Up to 6 months
measure: Motor symptoms
timeFrame: Up to 6 months
measure: Fear of falling
timeFrame: Up to 6 months
measure: Endurance
timeFrame: Up to 6 months
measure: bone health
timeFrame: up to 6 months
measure: Mood
timeFrame: up to 6 months
measure: Catalase
timeFrame: Up to 6 months
measure: Cytokines
timeFrame: Up to 6 months
Other outcomes:
measure: BDNF
timeFrame: up to 6 months
Locations:
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
Study officials:
affiliation: UNLV
name: Merrill Landers, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: