High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 45 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | August 2014 |
| End Date: | June 2015 |
| Contact: | Merrill Landers, PT, DPT, PhD |
| Email: | merrill.landers@unlv.edu |
| Phone: | 702-895-1377 |
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.
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.
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
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