Cycling in Parkinson's Disease

Not Applicable

Terminated

• Conditions: Parkinson's Disease
• Interventions: Other: Cycling at Forced rate; Other: Cycling at self-selected rate

• Registration Number: NCT02175082
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-21
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Forced exercise cycling	Cycling at Forced rate	Cycling exercise at approximately 90 rpm
Self-selected pace cycling	Cycling at self-selected rate	Cycling at self selected rate, with same aerobic level as forced cycling group

Primary Outcome Measures

Name	Time	Method
6-minute walk test	8 weeks	Distance walked in 6 minutes

Secondary Outcome Measures

Name	Time	Method
Step Width	8 weeks	Width of step in meters as measured by the GAITrite
Step variability	8 weeks	Standard deviation of step as measure in meters by the Gaitrite system
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.
Stride length	8 weeks	Length of stride in meters as measured by the GAITrite
10 meter walk test	8 weeks	Time in seconds for the subject to walk 10 meters

Trial Locations

Locations (1)

Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago); 🇺🇸 Chicago, Illinois, United States