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Telehealth Physical Activity Support for Parkinson's Disease

N/A
Waitlist Available
Research Sponsored by San Jose State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulatory for indoor and outdoor mobility without assistance or assistive device
Neurologist confirmed clinical diagnosis for Parkinson's disease Hoehn & Yahr stage I or II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 4 & 6 months
Awards & highlights

Study Summary

This trial is testing whether a physical activity intervention delivered via telehealth, with occupational therapists providing one-to-one support, can help people with early-mid stage Parkinson's disease.

Who is the study for?
This trial is for people with early to mid-stage Parkinson's disease who can move around indoors and outdoors without help. They must be cleared medically or complete a Physical Activity Readiness Questionnaire, and not already doing aerobic exercise for at least 30 minutes on most days.Check my eligibility
What is being tested?
The study tests a telehealth physical activity program delivered by occupational therapists versus standard disease management education. It aims to see if the program helps people with Parkinson's increase their physical activity as part of managing their condition.See study design
What are the potential side effects?
Since this trial involves an exercise program and educational support, side effects may include typical exercise-related issues such as muscle soreness or fatigue. However, participants are screened to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk indoors and outdoors without help or devices.
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I have been diagnosed with early-stage Parkinson's disease.
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I have been cleared for physical activity by completing the PAR-Q or getting a doctor's approval.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 4 & 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 4 & 6 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 From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months and 6 months
Change from baseline Brunel Lifestyle Physical Activity Questionnaire (Karageorghis, 2005) at 4 months and 6 months
Feasibility: Adherence
+1 more
Secondary outcome measures
Change From Baseline 30 second sit-to-stand at 4 Months and 6 months
Change From Baseline Life Space Assessment (Stalvey et al., 1999) at 4 Months and 6 months
Change From Baseline Modified 2 Minute Step Test at 4 Months and 6 months
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Occupational therapy intervention groupExperimental Treatment1 Intervention
Participants will receive 6 telehealth coaching sessions and 8 brief email or text check-ins over the course of 4 months. Participants will also receive a Fitbit and Engage PD Workbook.
Group II: Disease management education groupActive Control1 Intervention
Participants will receive online educational videos that they can watch at their own convenience over the course of 4 months. There will be up to 6 hours of content, and the links to these online videos will be provided via email. Following completion of the study, individuals in this group will receive an Engage PD Workbook and one OT coaching session, if they choose to.

Find a Location

Who is running the clinical trial?

San Jose State UniversityLead Sponsor
10 Previous Clinical Trials
1,891 Total Patients Enrolled
Teachers College, Columbia UniversityOTHER
24 Previous Clinical Trials
5,807 Total Patients Enrolled

Media Library

Disease management education group Clinical Trial Eligibility Overview. Trial Name: NCT05308238 — N/A
Parkinson's Disease Research Study Groups: Occupational therapy intervention group, Disease management education group
Parkinson's Disease Clinical Trial 2023: Disease management education group Highlights & Side Effects. Trial Name: NCT05308238 — N/A
Disease management education group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05308238 — N/A
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT05308238 — N/A

Frequently Asked Questions

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

Does this experiment preclude participation from those over 35 years old?

"As indicated by the entry requirements, any individual wishing to take part in this clinical trial must be at least 18 years old and no older than 85."

Answered by AI

Are there any opportunities to partake in this trial at the present moment?

"As per the information featured on clinicaltrials.gov, this trial is actively engaging with potential participants. It was initially made available for public viewing on April 18th 2022 and was last revised a week later."

Answered by AI

Is there an opportunity for me to participate in this clinical research?

"This clinical trial requires 50 participants with a diagnosis of Parkinson's disease and Hoehn & Yahr stage I or II. Patients should also be between 18-85 years old, ambulatory without assistance/device, and pass the Physical Activity Readiness Questionnaire (PAR-Q) or obtain medical clearance from their GP."

Answered by AI

What aims are this research endeavor seeking to accomplish?

"This clinical trial will primarily measure the adherence to treatment over a baseline, 4-month and 6-month timeframe. Secondary outcomes include change from baseline modified 2 minute step test at 4 months and 6 months, post-intervention acceptability questionnaire based on theoretical framework of acceptability as well as change from baseline timed-up-and go (TUG) at 4 months and 6 months which involves walking 3 meters with an accompanying caregiver for safety purposes while counting backwards by three starting at a random number between 20 and 100."

Answered by AI

What is the sample size of this investigation?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this trial commenced recruiting new participants on April 18th, 2022 and is presently open for applications. This study requires 50 individuals to be sourced from 2 different medical facilities."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
San Jose State Universty
Neurorehabilitation Research Laboratory
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

How frequently will I need to visit SJSU?
PatientReceived no prior treatments

Why did patients apply to this trial?

Willing to try new methods to slow the progression of PD. Have Parkinson's. Want to see what trials are out there that could help me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Pre-Active PD: Looking at Physical Activity Behavior Change in Parkinson's Disease
2022. "Pre-Active PD: Looking at Physical Activity Behavior Change in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05308238.
~17 spots leftby Apr 2025
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