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Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease Exercise Training | Other: High Intensity Interval Training Other: Continuous Moderate Intensity Training | Not Applicable |
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 : | 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 : | May 1, 2023 |
| Estimated Study Completion Date : | May 1, 2023 |
| 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.
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| 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.
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- Maximal exercise capacity [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]VO2 max
- Handgrip strength [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]Maximal handgrip strength
- Blood Pressure [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]Systolic and Diastolic Blood Pressure
- Heart Rate [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ]Cardiovascular measure
- 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.
- 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.
| Ages Eligible for Study: | 45 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
| Contact: Philip Millar, PhD | 1-519-824-4120 ext 54818 | pmillar@uoguelph.ca | |
| Contact: Lori Vallis, PhD | lvallis@uoguelph.ca |
| 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 | |
| Principal Investigator: | Philip Millar, PhD | University of Guelph |
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | April 29, 2019 | ||||||||
| First Posted Date ICMJE | May 7, 2019 | ||||||||
| Last Update Posted Date | April 2, 2021 | ||||||||
| Actual Study Start Date ICMJE | June 12, 2019 | ||||||||
| Estimated Primary Completion Date | May 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Maximal exercise capacity [ Time Frame: Change from baseline following 10 weeks of aerobic exercise training ] VO2 max
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease | ||||||||
| Official Title ICMJE | Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease | ||||||||
| 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). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 1, 2023 | ||||||||
| Estimated Primary Completion Date | May 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 45 Years to 85 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03940261 | ||||||||
| Other Study ID Numbers ICMJE | 18-08-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Philip Millar, University of Guelph | ||||||||
| Study Sponsor ICMJE | University of Guelph | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Guelph | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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