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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940261
• Other study ID #: 18-08-001
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: July 12, 2022

Study information

• Verified date: July 2022
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Exercise Training
• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Guelph	Parkinson Society Canada, YMCA

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal exercise capacity	VO2 max	Change from baseline following 10 weeks of aerobic exercise training
Secondary	Handgrip strength	Maximal handgrip strength	Change from baseline following 10 weeks of aerobic exercise training
Secondary	Blood Pressure	Systolic and Diastolic Blood Pressure	Change from baseline following 10 weeks of aerobic exercise training
Secondary	Heart Rate	Cardiovascular measure	Change from baseline following 10 weeks of aerobic exercise training
Secondary	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.	Change from baseline following 10 weeks of aerobic exercise training
Secondary	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.	Change from baseline following 10 weeks of aerobic exercise training