A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- 6-minute walk test
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Participants and those performing outcome assessments were not aware of group allotment, nor was the PI. The therapists supervising the exercise interventions were aware of the group allotment
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Any medical condition that the physician investigator determined would compromise safety.
Arms & Interventions
Forced exercise cycling
Cycling exercise at approximately 90 rpm
Intervention: Cycling at Forced rate (Other)
Self-selected pace cycling
Cycling at self selected rate, with same aerobic level as forced cycling group
Intervention: Cycling at self-selected rate (Other)
Outcomes
Primary Outcomes
6-minute walk test
Time Frame: 8 weeks
Distance walked in 6 minutes
Secondary Outcomes
- Step Width(8 weeks)
- Step variability(8 weeks)
- miniBESTest (Balance Evaluation Systems Test)(8 weeks)
- Stride length(8 weeks)
- 10 meter walk test(8 weeks)
Investigators
Christina Marciniak
Professor, Northwestern University and Attending Physician, Shirley Ryan AbilityLab
Shirley Ryan AbilityLab