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

July 26, 2022 updated by: Philip Millar, University of Guelph
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • University of Guelph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal exercise capacity
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
VO2 max
Change from baseline following 10 weeks of aerobic exercise training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
Maximal handgrip strength
Change from baseline following 10 weeks of aerobic exercise training
Blood Pressure
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
Systolic and Diastolic Blood Pressure
Change from baseline following 10 weeks of aerobic exercise training
Heart Rate
Time Frame: Change from baseline following 10 weeks of aerobic exercise training
Cardiovascular measure
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
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.
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
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.
Change from baseline following 10 weeks of aerobic exercise training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Collaborators

YMCA
Parkinson Society Canada

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Actual)

July 12, 2022

Study Completion (Actual)

July 12, 2022

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-08-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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