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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT02230267
• Date of registration: 27/08/2014
• Prospective Registration: No
• Primary sponsor: University of Nevada, Las Vegas
• Public title: High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease
• Scientific title: High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease
• Date of first enrolment: August 2014
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02230267
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Merrill Landers, PT, DPT, PhD
• Affiliation: UNLV

Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: High intensity exercise and balance training

Other: Usual care arm exercise

Primary Outcome(s)

Compliance [Time Frame: At the end of the 8 week trial]

Falls [Time Frame: At the end of the 8 week trial]

Aerobic feasibility [Time Frame: At the end of the 8 week trial]

Frequency feasibility [Time Frame: After completion of the 8 week trial]

Motivation [Time Frame: At 8 weeks]

Safety [Time Frame: Ongoing throughout the 8 week trial]

Strength feasibility [Time Frame: At the end of the 8 week trial]

Secondary Outcome(s)

Fear of falling [Time Frame: Up to 6 months]

Quality of life [Time Frame: up to 6 months]

Cognition [Time Frame: up to 6 months]

Endurance [Time Frame: Up to 6 months]

Fall Efficacy [Time Frame: Up to 6 months]

Mood [Time Frame: up to 6 months]

Motor activity [Time Frame: up to 6 months]

Cytokines [Time Frame: Up to 6 months]

Motor symptoms [Time Frame: Up to 6 months]

Falls [Time Frame: up to 6 months]

bone health [Time Frame: up to 6 months]

Catalase [Time Frame: Up to 6 months]

Fatigue [Time Frame: up to 6 months]

Long term behavioral change [Time Frame: up to 6 months]

Fall catastrophization [Time Frame: Up to 6 months]

Falls self-efficacy [Time Frame: up to 6 months]

Physical activity [Time Frame: Up to 6 months]

Strength [Time Frame: up to 6 months]

mini-Balance Evaluation Systems Test (mini-BESTest) [Time Frame: up to 6 months]

Secondary ID(s)

CTR-IN UNLVPT 2014.01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors