Clinical trial NCT02175082: Cycling in Parkinson's Disease
Official title: A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson Disease
Exercise
Rehabilitation
Physical Therapy
Cycling
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
name: Paul Ruby Foundation for Parkinson's Research
First posted: 2014-06-26
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


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
* Any medical condition that the physician investigator determined would compromise safety.

Primary outcomes:
measure: 6-minute walk test
timeFrame: 8 weeks
Secondary outcomes:
measure: Stride length
timeFrame: 8 weeks
measure: Step Width
timeFrame: 8 weeks
measure: Step variability
timeFrame: 8 weeks
measure: 10 meter walk test
timeFrame: 8 weeks
measure: miniBESTest (Balance Evaluation Systems Test)
timeFrame: 8 weeks
Other outcomes:
measure: Steps per day
timeFrame: Over 8 week trial and for 2 months post intervention
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab/Northwestern University Chicago IL
name: Christina M Marciniak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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