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Terminated prior to enrollment goals due to difficulty with recruiting subjects
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| Name | Class |
|---|---|
| Northwestern Memorial Hospital | OTHER |
| Paul Ruby Foundation for Parkinson's Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forced exercise cycling | Active Comparator | Cycling exercise at approximately 90 rpm |
|
| Self-selected pace cycling | Active Comparator | Cycling at self selected rate, with same aerobic level as forced cycling group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cycling at Forced rate | Other |
| ||
| Cycling at self-selected rate |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test | Distance walked in 6 minutes | 8 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Steps per day | Subjects steps per day will be measured with a Garmin wrist step counter | Over 8 week trial and for 2 months post intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina M Marciniak, MD | Shirley Ryan AbilityLab/Northwestern University Chicago IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago) | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Sung P, Rafferty M, Doyle L, Kliver E, Bines K, Traines J, Scarpa A, Marciniak C, Solanki S, Todd A. Technology-based Forced Paced Cycling in Parkinson's disease: Is it Feasible and Effective?Archives of PM&R October 2019Volume 100, Issue 10, Page e126 |
| Label | URL |
|---|---|
| Meeting abstract published | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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
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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
| Other |
|
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |