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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

Must not have

Other neurological diseases or disorders such as stroke

Musculoskeletal injury that would prevent participation in an exercise program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 4 & 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or other neurological conditions.

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I do not have any injuries that would stop me from exercising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 4 & 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met