NCT03940261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 12, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

April 29, 2019

Last Update Submit

July 26, 2022

Conditions

Keywords

High intensity interval training

Outcome Measures

Primary Outcomes (1)

  • Maximal exercise capacity

    VO2 max

    Change from baseline following 10 weeks of aerobic exercise training

Secondary Outcomes (5)

  • Handgrip strength

    Change from baseline following 10 weeks of aerobic exercise training

  • Blood Pressure

    Change from baseline following 10 weeks of aerobic exercise training

  • Heart Rate

    Change from baseline following 10 weeks of aerobic exercise training

  • Mini-Balance Evaluation Systems Test (Mini-BESTest)

    Change from baseline following 10 weeks of aerobic exercise training

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    Change from baseline following 10 weeks of aerobic exercise training

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL
Other: High Intensity Interval Training

Continuous Moderate Intensity Training

ACTIVE COMPARATOR
Other: Continuous Moderate Intensity Training

Interventions

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.

High Intensity Interval 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.

Continuous Moderate Intensity Training

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of dementia
  • History of stroke
  • Type 1 diabetes
  • Autonomic neuropathy
  • Currently involved in formal exercise training (\>3 day per week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philip Millar, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The collection of study outcomes will be completed by individuals blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to 10 weeks of either high intensity interval training or continuous moderate intensity training. Training will be conducted in parallel.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 7, 2019

Study Start

June 12, 2019

Primary Completion

July 12, 2022

Study Completion

July 12, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations