Parkinson's Disease
Conditions
Keywords
Parkinson Disease, Exercise, Rehabilitation, Physical Therapy, Cycling
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.
Interventions
OTHERCycling at Forced rate
OTHERCycling at self-selected rate
Sponsors
Northwestern Memorial Hospital
Paul Ruby Foundation for Parkinson's Research
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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
Intervention 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
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test | 8 weeks | Distance walked in 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stride length | 8 weeks | Length of stride in meters as measured by the GAITrite |
| Step Width | 8 weeks | Width of step in meters as measured by the GAITrite |
| 10 meter walk test | 8 weeks | Time in seconds for the subject to walk 10 meters |
| miniBESTest (Balance Evaluation Systems Test) | 8 weeks | Subject is scored as the 14 activities on this scale are performed, and a summary score is derived. |
| Step variability | 8 weeks | Standard deviation of step as measure in meters by the Gaitrite system |
Other
| Measure | Time frame | Description |
|---|---|---|
| Steps per day | Over 8 week trial and for 2 months post intervention | Subjects steps per day will be measured with a Garmin wrist step counter |
Countries
United States
Outcome results
None listed