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Cycling in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02175082
Recruitment Status : Terminated (Terminated prior to enrollment goals due to difficulty with recruiting subjects)
First Posted : June 26, 2014
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Northwestern Memorial Hospital
Paul Ruby Foundation for Parkinson's Research
Information provided by (Responsible Party):
Christina Marciniak, 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Cycling at Forced rate Other: Cycling at self-selected rate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes 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
Primary Purpose: Treatment
Official Title: A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?
Actual Study Start Date : June 2014
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 6-minute walk test [ Time Frame: 8 weeks ]
    Distance walked in 6 minutes


Secondary Outcome Measures :
  1. Stride length [ Time Frame: 8 weeks ]
    Length of stride in meters as measured by the GAITrite

  2. Step Width [ Time Frame: 8 weeks ]
    Width of step in meters as measured by the GAITrite

  3. Step variability [ Time Frame: 8 weeks ]
    Standard deviation of step as measure in meters by the Gaitrite system

  4. 10 meter walk test [ Time Frame: 8 weeks ]
    Time in seconds for the subject to walk 10 meters

  5. miniBESTest (Balance Evaluation Systems Test) [ Time Frame: 8 weeks ]
    Subject is scored as the 14 activities on this scale are performed, and a summary score is derived.


Other Outcome Measures:
  1. Steps per day [ Time Frame: Over 8 week trial and for 2 months post intervention ]
    Subjects steps per day will be measured with a Garmin wrist step counter



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175082


Locations
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United States, Illinois
Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Shirley Ryan AbilityLab
Northwestern Memorial Hospital
Paul Ruby Foundation for Parkinson's Research
Investigators
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Principal Investigator: Christina M Marciniak, MD Shirley Ryan AbilityLab/Northwestern University Chicago IL
Additional Information:
Publications of Results:
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

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Responsible Party: Christina Marciniak, Professor, Northwestern University and Attending Physician, Shirley Ryan AbilityLab, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT02175082    
Other Study ID Numbers: STU00093757
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christina Marciniak, Shirley Ryan AbilityLab:
Parkinson Disease
Exercise
Rehabilitation
Physical Therapy
Cycling
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases