Cycling in Parkinson's Disease

NCT02175082 | Terminated

• 1 other identifier: STU00093757
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson Disease; Exercise; Rehabilitation; Physical Therapy; Cycling

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test

  Distance walked in 6 minutes

  8 weeks

Secondary Outcomes (5)

• Stride length

  8 weeks

• Step Width

  8 weeks

• Step variability

  8 weeks

• 10 meter walk test

  8 weeks

• miniBESTest (Balance Evaluation Systems Test)

  8 weeks

Other Outcomes (1)

• Steps per day

  Over 8 week trial and for 2 months post intervention

Study Arms (2)

Forced exercise cycling

ACTIVE COMPARATOR

Cycling exercise at approximately 90 rpm

Other: Cycling at Forced rate

Self-selected pace cycling

ACTIVE COMPARATOR

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

Other: Cycling at self-selected rate

Interventions

Cycling at Forced rate OTHER

Forced exercise cycling

Cycling at self-selected rate OTHER

Self-selected pace cycling

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Northwestern Memorial Hospital: collaborator
• Paul Ruby Foundation for Parkinson's Research: collaborator

Study Sites (1)

Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)

Chicago, Illinois, 60611, United States

Location

Related 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

  RESULT

Related Links

• Meeting abstract published

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Christina M Marciniak, MD

  Shirley Ryan AbilityLab/Northwestern University Chicago IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Northwestern University and Attending Physician, Shirley Ryan AbilityLab

Model Details: 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

Study Record Dates

• First Submitted: June 21, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)