A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- 6-minute walk test
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to assess the effectiveness of a forced exercise aerobic exercise program, utilizing a cycling activity, on specific gait parameters and balance in individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control, evaluator blinded. Subjects: Twenty four patients with idiopathic PD Hoehn and Yahr (H&Y) stage II or III. Intervention: Participants randomly assigned to one of two exercise groups, forced exercise or self selected exercise, on cycling machine three times a week for 8 weeks. Both groups to exercise at same aerobic intensity level to keep heart rate at 60-80% heart rate max. Outcomes: Gait parameters of step length, width, and variability as measured by the GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise tolerance via Patient Reported Outcomes Measurement Information System (PROMIS) scale.
Investigators
Christina Marciniak
Professor, Northwestern University and Attending Physician, Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
Eligibility Criteria
Inclusion Criteria
- •Idiopathic Parkinson's Disease
- •Hoehn and Yahr Stages II - III.
- •Ages 30-80 years
- •Medical Clearance
- •Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- •MOCA: (Montreal Cognition Scale) : rating of less than 24, indicative of cognitive dysfunction
- •Changes in Parkinson's medications within the two weeks prior to starting the study
- •Anticipated change in Parkinson Disease medications during the course of the study
- •Uncontrolled orthostasis
- •Symptomatic coronary artery disease
- •Fracture of lower limb within 6 months prior to study onset or significant lower limb orthopedic diagnosis that would limit cycling
- •Other significant neurologic diagnoses including multiple sclerosis or vestibular disease
- •Acute illness
- •Physical therapy within the month prior to study entry
- •Subjects already participating in a forced exercise or high intensity exercise program
Outcomes
Primary Outcomes
6-minute walk test
Time Frame: 8 weeks
Distance walked in 6 minutes
Secondary Outcomes
- miniBESTest (Balance Evaluation Systems Test)(8 weeks)
- Step Width(8 weeks)
- Step variability(8 weeks)
- Stride length(8 weeks)
- 10 meter walk test(8 weeks)