High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease

NCT ID: NCT02230267

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-12-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High intensity boot camp

Each of the two HIBCs will have 10 participants (20 total) with a 1:5 physical therapist-to-patient ratio. Each HIBC session will last 1.5 hours and will be held on 4 days of the week. Participants will be required to attend 3 of those 4 days but may attend all. Because this is a pragmatic trial, therapists will have some leeway to control the intensity and the modality of the exercise. However, the basic format of the HIBC will consist of the following exercise components: 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; and, D. 15 minutes of rest and stretching. Participants will rotate through these four different exercise components in a circuit fashion.

Group Type: EXPERIMENTAL

High intensity exercise and balance training

Intervention Type: OTHER

Usual care arm

The low intensity exercise group will participate in the Fitness Counts Exercise Program (FCEP) which is a basic low intensity, sitting and standing exercise program (10 minutes of stretching, 10 minutes of aerobic exercise (60% of heart rate maximum), and 10 minutes of strengthening). This exercise program was developed by the National Parkinson Foundation and is commonly used in PD exercise classes. The physical therapist-to-patient ratio will be 1:5. As there are two clinical sites, there will be 10 participants in each of the two boot camps (20 total). The FCEP will be 1 hour daily on four days of the week. Participants will be required to attend 3 days per week but may attend more if they are able.

Group Type: ACTIVE_COMPARATOR

Usual care arm exercise

Intervention Type: OTHER

Interventions

High intensity exercise and balance training

Intervention Type: OTHER

Usual care arm exercise

Intervention Type: OTHER

Other Intervention Names

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

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Merrill Landers

Chair and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merrill Landers, PT, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

UNLV

Locations

University of Nevada, Las Vegas

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

CTR-IN UNLVPT 2014.01

Identifier Type: -

Identifier Source: org_study_id