Cycling in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02175082
• Other study ID #: STU00093757
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2019

Study information

• Verified date: October 2020
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Cycling at Forced rate

• Cycling at self-selected rate

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Northwestern Memorial Hospital, Paul Ruby Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	6-minute walk test	Distance walked in 6 minutes	8 weeks
Secondary	Stride length	Length of stride in meters as measured by the GAITrite	8 weeks
Secondary	Step Width	Width of step in meters as measured by the GAITrite	8 weeks
Secondary	Step variability	Standard deviation of step as measure in meters by the Gaitrite system	8 weeks
Secondary	10 meter walk test	Time in seconds for the subject to walk 10 meters	8 weeks
Secondary	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

External Links

•   Meeting abstract published