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Cycling in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cycling at Forced rate
Cycling at self-selected rate
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson Disease, Exercise, Rehabilitation, Physical Therapy, Cycling

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Forced exercise cycling

Self-selected pace cycling

Arm Description

Cycling exercise at approximately 90 rpm

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

Outcomes

Primary Outcome Measures

6-minute walk test
Distance walked in 6 minutes

Secondary Outcome Measures

Stride length
Length of stride in meters as measured by the GAITrite
Step Width
Width of step in meters as measured by the GAITrite
Step variability
Standard deviation of step as measure in meters by the Gaitrite system
10 meter walk test
Time in seconds for the subject to walk 10 meters
miniBESTest (Balance Evaluation Systems Test)
Subject is scored as the 14 activities on this scale are performed, and a summary score is derived.

Full Information

First Posted
June 21, 2014
Last Updated
October 19, 2020
Sponsor
Shirley Ryan AbilityLab
Collaborators
Northwestern Memorial Hospital, Paul Ruby Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT02175082
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated prior to enrollment goals due to difficulty with recruiting subjects
Study Start Date
June 2014 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Northwestern Memorial Hospital, Paul Ruby Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson Disease, Exercise, Rehabilitation, Physical Therapy, Cycling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants and those performing outcome assessments were not aware of group allotment, nor was the PI. The therapists supervising the exercise interventions were aware of the group allotment
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forced exercise cycling
Arm Type
Active Comparator
Arm Description
Cycling exercise at approximately 90 rpm
Arm Title
Self-selected pace cycling
Arm Type
Active Comparator
Arm Description
Cycling at self selected rate, with same aerobic level as forced cycling group
Intervention Type
Other
Intervention Name(s)
Cycling at Forced rate
Intervention Type
Other
Intervention Name(s)
Cycling at self-selected rate
Primary Outcome Measure Information:
Title
6-minute walk test
Description
Distance walked in 6 minutes
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Stride length
Description
Length of stride in meters as measured by the GAITrite
Time Frame
8 weeks
Title
Step Width
Description
Width of step in meters as measured by the GAITrite
Time Frame
8 weeks
Title
Step variability
Description
Standard deviation of step as measure in meters by the Gaitrite system
Time Frame
8 weeks
Title
10 meter walk test
Description
Time in seconds for the subject to walk 10 meters
Time Frame
8 weeks
Title
miniBESTest (Balance Evaluation Systems Test)
Description
Subject is scored as the 14 activities on this scale are performed, and a summary score is derived.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Steps per day
Description
Subjects steps per day will be measured with a Garmin wrist step counter
Time Frame
Over 8 week trial and for 2 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M Marciniak, MD
Organizational Affiliation
Shirley Ryan AbilityLab/Northwestern University Chicago IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
result
Links:
URL
https://doi.org/10.1016/j.apmr.2019.08.377
Description
Meeting abstract published

Learn more about this trial

Cycling in Parkinson's Disease

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