Cycling in Parkinson's Disease

Shirley Ryan AbilityLab

Status: Terminated

Conditions: Parkinson's Disease

Treatments: Other: Cycling at Forced rate; Other: Cycling at self-selected rate

Study type: Interventional

Funder types: Other

Identifiers

NCT02175082

STU00093757

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Forced exercise cycling

Active Comparator group

Description:

Cycling exercise at approximately 90 rpm

Treatment:

Other: Cycling at Forced rate

Self-selected pace cycling

Active Comparator group

Description:

Cycling at self selected rate, with same aerobic level as forced cycling group

Treatment:

Other: Cycling at self-selected rate