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

Sponsor
University of Guelph (Other)
Overall Status
Completed
CT.gov ID
NCT03940261
Collaborator
Parkinson Society Canada (Other), YMCA (Other)
28
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2
37
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High Intensity Interval Training
  • Other: Continuous Moderate Intensity Training
N/A

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

Study Type:
Interventional
Actual Enrollment :
28 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.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 :
Jun 12, 2019
Actual Primary Completion Date :
Jul 12, 2022
Actual Study Completion Date :
Jul 12, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Maximal exercise capacity [Change from baseline following 10 weeks of aerobic exercise training]

    VO2 max

Secondary Outcome Measures

  1. Handgrip strength [Change from baseline following 10 weeks of aerobic exercise training]

    Maximal handgrip strength

  2. Blood Pressure [Change from baseline following 10 weeks of aerobic exercise training]

    Systolic and Diastolic Blood Pressure

  3. Heart Rate [Change from baseline following 10 weeks of aerobic exercise training]

    Cardiovascular measure

  4. Mini-Balance Evaluation Systems Test (Mini-BESTest) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 85 Years
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

  • Type 1 diabetes

  • Autonomic neuropathy

  • Currently involved in formal exercise training (>3 day per week).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Guelph Guelph Ontario Canada N1G 2W1

Sponsors and Collaborators

  • University of Guelph
  • Parkinson Society Canada
  • YMCA

Investigators

  • Principal Investigator: Philip Millar, PhD, University of Guelph

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philip Millar, Assistant Professor, University of Guelph
ClinicalTrials.gov Identifier:
NCT03940261
Other Study ID Numbers:
  • 18-08-001
First Posted:
May 7, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Philip Millar, Assistant Professor, University of Guelph
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022