Parkinson DiseaseNCT03940261
Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
A study testing High Intensity Interval Training and Continuous Moderate Intensity Training in people with Parkinson Disease and Exercise Training, run by University of Guelph at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease, Exercise Training
- What is being tested?
- High Intensity Interval Training and Continuous Moderate Intensity Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2019to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of dementia
- History of stroke
- Type 1 diabetes
- Autonomic neuropathy
- Currently involved in formal exercise training (>3 day per week).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Parkinson Disease, Exercise Training
- Being tested
- High Intensity Interval Training, Continuous Moderate Intensity Training
- Keywords
- High intensity interval training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
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.
Continuous Moderate Intensity TrainingOther
Participants will complete exercise training 3x/week for 10 weeks. Exercise will consist of 30-50 minutes of cycling at 60% peak power output.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | Not described Receives: Other: High Intensity Interval Training |
| Continuous Moderate Intensity Training | Active comparator | Not described Receives: Other: Continuous Moderate Intensity Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity
VO2 max
Measured: Change from baseline following 10 weeks of aerobic exercise training
Secondary outcomes (5)
Handgrip strength
Maximal handgrip strength
Measured: Change from baseline following 10 weeks of aerobic exercise training
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: Change from baseline following 10 weeks of aerobic exercise training
Heart Rate
Cardiovascular measure
Measured: Change from baseline following 10 weeks of aerobic exercise training
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.
Measured: Change from baseline following 10 weeks of aerobic exercise training
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.
Measured: Change from baseline following 10 weeks of aerobic exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start12 Jun 2019
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson Society Canada, YMCA
- Responsible party
- Principal investigator, Philip Millar, University of Guelph
- Investigators
- Philip Millar, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940261
- Sponsor's protocol ID
- 18-08-001
- Status last verified
- Jul 2022
- First submitted
- 29 Apr 2019
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03940261
- Acronym / sponsor ID
- 18-08-001
- Conditions
- Parkinson Disease, Exercise Training
- Keywords
- High intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Parkinson Society Canada, YMCA
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Other: High Intensity Interval Training |
| Continuous Moderate Intensity Training | Active comparator | Other: Continuous Moderate Intensity Training |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- History of dementia
- History of stroke
- Type 1 diabetes
- Autonomic neuropathy
- Currently involved in formal exercise training (>3 day per week).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingParticipants 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. | Other | High Intensity Interval Training |
| Continuous Moderate Intensity TrainingParticipants will complete exercise training 3x/week for 10 weeks. Exercise will consist of 30-50 minutes of cycling at 60% peak power output. | Other | Continuous Moderate Intensity Training |
Primary outcome
Maximal exercise capacity
Time frame: Change from baseline following 10 weeks of aerobic exercise training
VO2 max
5 secondary outcomes
Handgrip strength
Time frame: Change from baseline following 10 weeks of aerobic exercise training
Blood Pressure
Time frame: Change from baseline following 10 weeks of aerobic exercise training
Heart Rate
Time frame: 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
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Change from baseline following 10 weeks of aerobic exercise training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Millar, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Continuous Moderate Intensity Training in people with Parkinson Disease and Exercise Training, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal exercise capacity (time frame: Change from baseline following 10 weeks of aerobic exercise training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.