Cycling in Parkinson's Disease

• Sponsor: Shirley Ryan AbilityLab (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02175082
• Collaborator: Northwestern Memorial Hospital (Other), Paul Ruby Foundation for Parkinson's Research (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 60
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Other: Cycling at Forced rate; Other: Cycling at self-selected rate	N/A

Study Design

• Study Type: Interventional
• 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 levelsSubjects 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: Jun 1, 2014
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 6-minute walk test [8 weeks]

   Distance walked in 6 minutes

Secondary Outcome Measures

1. Stride length [8 weeks]

   Length of stride in meters as measured by the GAITrite

2. Step Width [8 weeks]

   Width of step in meters as measured by the GAITrite

3. Step variability [8 weeks]

   Standard deviation of step as measure in meters by the Gaitrite system

4. 10 meter walk test [8 weeks]

   Time in seconds for the subject to walk 10 meters

5. 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.

Other Outcome Measures

1. Steps per day [Over 8 week trial and for 2 months post intervention]

   Subjects steps per day will be measured with a Garmin wrist step counter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Christina M Marciniak, MD, Shirley Ryan AbilityLab/Northwestern University Chicago IL

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Meeting abstract published

Publications

None provided.

• 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: Jun 26, 2014
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Christina Marciniak, Professor, Northwestern University and Attending Physician, Shirley Ryan AbilityLab, Shirley Ryan AbilityLab: Parkinson Disease; Exercise; Rehabilitation; Physical Therapy; Cycling
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Oct 22, 2020