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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02230267
• Other study ID #: CTR-IN UNLVPT 2014.01
• Status: Recruiting
• Phase: Phase 2
• First received: August 27, 2014
• Last updated: May 26, 2015
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: University of Nevada, Las Vegas
• Contact: Merrill Landers, PT, DPT, PhD
• Phone: 702-895-1377
• Email: merrill.landers[@]unlv.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• High intensity exercise and balance training

• Usual care arm exercise

Locations

Country	Name	City	State
United States	University of Nevada, Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BDNF	Circulating BDNF concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.	up to 6 months	No
Primary	Frequency feasibility	The number of participants that attend and participate in the treatment at least 3 times per week for 8 weeks.	After completion of the 8 week trial	No
Primary	Aerobic feasibility	The number of participants that complete at least 150 minutes per week of moderate intensity exercise (70%+ of their estimated HR maximum). This will be ascertained using heart rate monitors.	At the end of the 8 week trial	No
Primary	Strength feasibility	The number of participants that participate in strengthening exercises that incorporates all the major muscle groups at least two days per week.	At the end of the 8 week trial	No
Primary	Compliance	Drop-out rate and reason for drop-out will be tracked.	At the end of the 8 week trial	No
Primary	Safety	Exercise-related adverse events (e.g., strains/sprains, cardiovascular events).	Ongoing throughout the 8 week trial	Yes
Primary	Motivation	The Intrinsic Motivation Inventory (IMI) will be used to gather information about motivation.	At 8 weeks	No
Primary	Falls	Falls and fall injuries in and out of boot camp will be collected.	At the end of the 8 week trial	Yes
Secondary	Falls	Falls will be tracked for 6 months after the boot camp using a falls diary. A member of the research team will call each month to interview participants about their falls. We will assess falls/fall injuries per physical activity ratio during the 6 month period following the trial and time to a fall/fall injury after the trial.	up to 6 months	No
Secondary	Motor activity	Physical activity will be assessed using the Physical Activity Monitoring System (PAMsys).	up to 6 months	No
Secondary	Fatigue	Fatigue will be assessed using the Parkinson Fatigue Scale (PFS).	up to 6 months	No
Secondary	Strength	This will be assessed functionally using the 30 second Sit-To-Stand Test (30STS) for muscle strength.	up to 6 months	No
Secondary	Cognition	Cognition will be assessed using the Montreal Cognitive Assessment (MoCA).	up to 6 months	No
Secondary	Quality of life	This will be assessed by using a measure of disease-specific quality of life (Parkinson's Disease Questionnaire-39 (PDQ39)).	up to 6 months	No
Secondary	Long term behavioral change	All participants will track their participation in exercise and physical activity using an exercise diary for 6 months following the boot camp. Participants will be called monthly to reinforce completion of the exercise diary.	up to 6 months	No
Secondary	mini-Balance Evaluation Systems Test (mini-BESTest)	Performance-based balance tasks.	up to 6 months	No
Secondary	Falls self-efficacy	Activities Specific Balance Confidence Scale (ABC)	up to 6 months	No
Secondary	Fall Efficacy	Self-report measurement tool: Falls Efficacy Scale (FES)	Up to 6 months	No
Secondary	Fall catastrophization	Self-report of fall catastrophization: Catastrophization about Falls Questionnaire (CAFS)	Up to 6 months	No
Secondary	Physical activity	Self-report measure physical activity: International Physical Activity Questionnaire (IPAQ)	Up to 6 months	No
Secondary	Motor symptoms	Unified Parkinson's Disease Rating Scale motor subscale (UDPRS III)	Up to 6 months	No
Secondary	Fear of falling	Self-report scale of avoidance behavior due to a fear of falling: Fear of Falls Avoidance Behavior Questionnaire (FFABQ)	Up to 6 months	No
Secondary	Endurance	Endurance will be assessed using the 6 Minute Walk Test (6MWT).	Up to 6 months	No
Secondary	bone health	Bone health will be measured using bone mineral densiometry (BMD).	up to 6 months	No
Secondary	Mood	Mood will be measured using the Beck Depression Inventory.	up to 6 months	No
Secondary	Catalase	Catalase concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.	Up to 6 months	No
Secondary	Cytokines	Cytokine (TNFa, IL-6, IL-10) concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.	Up to 6 months	No