- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03940261
Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific research aims are to compare, in PD, the effects of HIIT or CMIT on: 1) maximal exercise capacity; 2) neural and non-neural factors contributing to muscle strength, power and fatigability; 3) biomechanical measures of postural stability and gait; and 4) Clinical markers (Mini-BESTest and Unified Parkinson's Disease Rating Scale (UPDRS)). The investigators hypothesize that, HIIT will produce greater improvements in: 1) exercise capacity; 2) muscle strength, power and reduced fatigability; 3) stability and gait velocity; and 4) clinical markers.
Methods: This pilot project will involve a randomized trial of 30 individuals with PD comparing the effects of HIIT and CMIT. Training will be completed thrice weekly for 10 weeks. Participants will include men and women between 50-85 years of age, who are able to stand unsupported for 1 min, walk 18m without use of an aid, and mount a stationary bike. Participants will be randomized to either HIIT (10, 1-minute cycling intervals at 90% of peak power output, each separated by 1-min at 10% peak power output) or CMIT (30-50min cycling at 60% of peak power output). Participants will undergo the following pre- and post-training assessments: Cardiovascular testing will examine hemodynamic and efferent muscle sympathetic responses to static handgrip exercise and post-exercise circulatory occlusion; Neuromuscular testing will examine muscle activity (electromyography) during voluntary and electrically stimulated contractions of the knee extensors; Biomechanical testing will examine whole-body stability, gait, and balance patterns; and Clinical risk assessments (Mini-BESTest and UPDRS).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women between 45-85 years of age
- Clinical diagnosis of Parkinson disease
- Able to stand unsupported for 1 minute
- Able to walk 18 metres without aid
- Able to mount a stationary bike
Exclusion Criteria:
- History of dementia
- History of stroke
- Type 1 diabetes
- Autonomic neuropathy
- Currently involved in formal exercise training (>3 day per week).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Interval Training
|
Participants will complete exercise training 3x/week for 10 weeks.
Exercise will consist of 10, 1-minute cycling intervals at 90% of peak power output, each separated by 1-min at 10% peak power output.
|
|
Active Comparator: Continuous Moderate Intensity Training
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Participants will complete exercise training 3x/week for 10 weeks.
Exercise will consist of 30-50 minutes of cycling at 60% peak power output.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal exercise capacity
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
|
VO2 max
|
Change from baseline following 10 weeks of aerobic exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip strength
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
|
Maximal handgrip strength
|
Change from baseline following 10 weeks of aerobic exercise training
|
|
Blood Pressure
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
|
Systolic and Diastolic Blood Pressure
|
Change from baseline following 10 weeks of aerobic exercise training
|
|
Heart Rate
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
|
Cardiovascular measure
|
Change from baseline following 10 weeks of aerobic exercise training
|
|
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
|
Rating scale consisting of 14 items that are each scored from 0-2, where "0" indicates the lowest level of function and "2" the highest level of function.
The test has a maximum score of 28 points.
|
Change from baseline following 10 weeks of aerobic exercise training
|
|
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
|
We will use the rating scale to examine 3 segments.
1) MENTATION, BEHAVIOR AND MOOD - 4 questions scored between "0" and "4"; 2) ACTIVITIES OF DAILY LIVING - 13 questions scored between "0" and "4"; and 3) MOTOR EXAMINATION - 14 questions scored between "0" and "4".
In each case, a score of "0" indicates normal responses.
|
Change from baseline following 10 weeks of aerobic exercise training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Millar, PhD, University of Guelph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-08-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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