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Cycling Groups for Parkinson's Disease

N/A

Recruiting

Led By Kristen A Pickett, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of idiopathic "definite PD" based upon established criteria

Vision at or corrected to 20/40 or better

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-test (~6-months), 3-month follow up (~9-months)

Awards & highlights

Study Summary

This trial will study an at-home, progressive cycling program for people with Parkinson's Disease to see if it's effective and how social support affects it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have been diagnosed with definite Parkinson's disease according to recognized criteria.

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Your vision is 20/40 or better, even with glasses or contacts.

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You can walk by yourself for at least 10 minutes without stopping.

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You do not have any other brain or nerve diseases besides Parkinson's disease.

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You scored 78 or higher on a test that checks for signs of memory problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-test (~6-months), 3-month follow up (~9-months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-test (~6-months), 3-month follow up (~9-months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-test (~6-months), 3-month follow up (~9-months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Canadian Occupational Performance Measure (COPM) scores

Gait

Change in Standardized Gait Analysis: Gait Velocity

+2 more

Secondary outcome measures

Change in Activity Level Measured by Number of Steps Taken per day

Accidental Falls

Change in Four Square Step Test

+2 more

Other outcome measures

Change in Free Locomotion Gait Analysis: Acceleration

Gait

Change in Free Locomotion Gait Analysis: Relative Distance

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Study 2: Solo Cycling GroupExperimental Treatment1 Intervention

Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to cycling without a partner for a target duration and intensity.

Group II: Study 2: Social Cycling GroupExperimental Treatment1 Intervention

Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present.

Group III: Study 1: Social Cycling GroupExperimental Treatment1 Intervention

Group IV: Study 1: Normal Care Control GroupActive Control1 Intervention

Study 1: Normal Care Control Group [will crossover and complete the cycling intervention following the initial 6-months]

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH

319 Previous Clinical Trials

401,679 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,177 Previous Clinical Trials

2,742,110 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,686 Previous Clinical Trials

6,930,828 Total Patients Enrolled

Media Library

Social Cycling Group Clinical Trial Eligibility Overview. Trial Name: NCT04300023 — N/A

Parkinson's Disease Research Study Groups: Study 2: Solo Cycling Group, Study 1: Social Cycling Group, Study 2: Social Cycling Group, Study 1: Normal Care Control Group

Parkinson's Disease Clinical Trial 2023: Social Cycling Group Highlights & Side Effects. Trial Name: NCT04300023 — N/A

Social Cycling Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04300023 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the current iteration of this clinical trial offer enrolment opportunities?

"Yes, according to the information on clinicaltrials.gov this study is open for participation and has been since August 25th 2021. This trial requires 52 participants at one location, and was recently updated on September 3rd 2021."

Answered by AI

How many participants are being enrolled in this medical experiment?

"Affirmative. The clinical trial, which was originally posted on the 25th of August 2021 and recently updated on September 3rd is seeking participants. In total 52 patients will be admitted across 1 medical site."

Answered by AI

What principal aim is this research attempting to fulfill?

"This research trial, which will be evaluated at baseline, post-test (~6 months) and 3 month follow up (~9 months), has the primary goal of assessing Change in Standardized Gait Analysis: Gait Velocity. Additionally, it seeks to measure Change in Pittsburgh Sleep Quality Index (a 0-21 scale where higher scores denote greater difficulty sleeping), Change in Timed Up and Go Test (the time taken for a participant to stand up from sitting, walk three metres away then return to their seat again) as well as Change in Fall Frequency (assessed by six questions regarding fall rate over two weeks/month/six months etc"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

In-home Cycling for Individuals With PD: Feasibility

2021. "In-home Cycling for Individuals With PD: Feasibility". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04300023.