Cycling in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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Forced exercise cycling

Cycling exercise at approximately 90 rpm

Group Type ACTIVE_COMPARATOR

Cycling at Forced rate

Intervention Type OTHER

Self-selected pace cycling

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

Group Type ACTIVE_COMPARATOR

Cycling at self-selected rate

Intervention Type OTHER

Interventions

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Cycling at Forced rate

Intervention Type OTHER

Cycling at self-selected rate

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No