Cycling in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Cycling at Forced rate
* Other: Cycling at self-selected rate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects were randomized to a delay start or immediate start group and then for the cycling, the intervention was randomized to : forced pace (80-90 revolutions per minute with equals 15 miles per hour cycling rate or self-selected with both groups working at similar aerobic levels
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Forced exercise cycling<br>Cycling exercise at approximately 90 rpm | Other: Cycling at Forced rate<br> <br> |
| Active Comparator: Self-selected pace cycling<br>Cycling at self selected rate, with same aerobic level as forced cycling group | Other: Cycling at self-selected rate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test | Distance walked in 6 minutes | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stride length | Length of stride in meters as measured by the GAITrite | 8 weeks | 
| Step Width | Width of step in meters as measured by the GAITrite | 8 weeks | 
| Step variability | Standard deviation of step as measure in meters by the Gaitrite system | 8 weeks | 
| 10 meter walk test | Time in seconds for the subject to walk 10 meters | 8 weeks | 
| miniBESTest (Balance Evaluation Systems Test) | Subject is scored as the 14 activities on this scale are performed, and a summary score is derived. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Exercise, Rehabilitation, Physical Therapy, Cycling