Cycling in Parkinson's Disease

A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Cycling at Forced rate; Other: Cycling at self-selected rate

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Forced exercise cycling; Cycling exercise at approximately 90 rpm	Other: Cycling at Forced rate
Active Comparator: Self-selected pace cycling; Cycling at self selected rate, with same aerobic level as forced cycling group	Other: Cycling at self-selected rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test	Distance walked in 6 minutes	8 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: Northwestern Memorial Hospital; Paul Ruby Foundation for Parkinson's Research
• Investigators: Principal Investigator: Christina M Marciniak, MD, Shirley Ryan AbilityLab/Northwestern University Chicago IL

Publications and helpful links

General Publications

• 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

Helpful Links

• Meeting abstract published

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 21, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Cycling; Physical Therapy; Parkinson Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: STU00093757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No