Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
Primary Purpose
Parkinson Disease, Exercise Training
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Interval Training
Continuous Moderate Intensity Training
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring High intensity interval training
Eligibility Criteria
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).
Sites / Locations
- University of Guelph
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Intensity Interval Training
Continuous Moderate Intensity Training
Arm Description
Outcomes
Primary Outcome Measures
Maximal exercise capacity
VO2 max
Secondary Outcome Measures
Handgrip strength
Maximal handgrip strength
Blood Pressure
Systolic and Diastolic Blood Pressure
Heart Rate
Cardiovascular measure
Mini-Balance Evaluation Systems Test (Mini-BESTest)
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.
Unified Parkinson's Disease Rating Scale (UPDRS)
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.
Full Information
NCT ID
NCT03940261
First Posted
April 29, 2019
Last Updated
July 26, 2022
Sponsor
University of Guelph
Collaborators
Parkinson Society Canada, YMCA
1. Study Identification
Unique Protocol Identification Number
NCT03940261
Brief Title
Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
Official Title
Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Parkinson Society Canada, YMCA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aerobic exercise is recommended for individuals with Parkinson's disease (PD) and can improve quality of life, both physically and mentally. The most efficacious program to achieve these exercise benefits is unknown. Recently, high-intensity interval training (HIIT) has been shown to be safe and more effective in many high-risk populations with limited exercise tolerance. Shorter bouts of exercise are likely better tolerated in PD due to difficulty sustaining muscle contractions. The goal of this project is to determine whether HIIT produces superior cardiorespiratory, neuromuscular, biomechanical, and clinical adaptations than conventional continuous moderate intensity training (CMIT) in PD.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Exercise Training
Keywords
High intensity interval training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to 10 weeks of either high intensity interval training or continuous moderate intensity training. Training will be conducted in parallel.
Masking
Outcomes Assessor
Masking Description
The collection of study outcomes will be completed by individuals blinded to group allocation.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Title
Continuous Moderate Intensity Training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Continuous Moderate Intensity Training
Intervention Description
Participants will complete exercise training 3x/week for 10 weeks. Exercise will consist of 30-50 minutes of cycling at 60% peak power output.
Primary Outcome Measure Information:
Title
Maximal exercise capacity
Description
VO2 max
Time Frame
Change from baseline following 10 weeks of aerobic exercise training
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Maximal handgrip strength
Time Frame
Change from baseline following 10 weeks of aerobic exercise training
Title
Blood Pressure
Description
Systolic and Diastolic Blood Pressure
Time Frame
Change from baseline following 10 weeks of aerobic exercise training
Title
Heart Rate
Description
Cardiovascular measure
Time Frame
Change from baseline following 10 weeks of aerobic exercise training
Title
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Description
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.
Time Frame
Change from baseline following 10 weeks of aerobic exercise training
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
Change from baseline following 10 weeks of aerobic exercise training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Millar, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada
12. IPD Sharing Statement
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Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
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