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Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03940261
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
Parkinson Society Canada
YMCA
Information provided by (Responsible Party):
Philip Millar, University of Guelph

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Exercise Training Other: High Intensity Interval Training Other: Continuous Moderate Intensity Training Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: The collection of study outcomes will be completed by individuals blinded to group allocation.
Primary Purpose: Treatment
Official Title: Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Training Other: 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 Other: Continuous Moderate Intensity Training
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 Measures :
  1. Maximal exercise capacity [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]
    VO2 max


Secondary Outcome Measures :
  1. Handgrip strength [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]
    Maximal handgrip strength

  2. Blood Pressure [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]
    Systolic and Diastolic Blood Pressure

  3. Heart Rate [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]
    Cardiovascular measure

  4. 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.

  5. 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.



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Diabetes
  • Autonomic neuropathy
  • Currently involved in formal exercise training (>3 day per week).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940261


Contacts
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Contact: Philip Millar, PhD 1-519-824-4120 ext 54818 pmillar@uoguelph.ca
Contact: Lori Vallis, PhD lvallis@uoguelph.ca

Locations
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Canada, Ontario
University of Guelph Recruiting
Guelph, Ontario, Canada, N1G 2W1
Contact: Philip Millar, PhD    1-519-824-4120 ext 54818    pmillar@uoguelph.ca   
Contact: Lori Vallis, PhD       lvallis@uoguelph.ca   
Sponsors and Collaborators
University of Guelph
Parkinson Society Canada
YMCA
Investigators
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Principal Investigator: Philip Millar, PhD University of Guelph

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Responsible Party: Philip Millar, Assistant Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT03940261     History of Changes
Other Study ID Numbers: 18-08-001
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Millar, University of Guelph:
High intensity interval training
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases