- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575479
PA Behavior and HRQoL in Parkinson's Disease Patients Patients: Role of Social Cognitive Variables (PDQ)
Physical Activity Behavior and Health-Related Quality of Life in Parkinson's Disease Patients: Role of Social Cognitive Variables
Study Overview
Status
Detailed Description
The body of evidence in the physical therapy and rehabilitation literature supports that physical activity is associated with improvements in quality of life for Parkinson's Disease (PD) patients. However, few studies have examined the underlying variables that may account for this relationship in PD patients. Researchers have examined stages of readiness to exercise in PD patients and barriers to exercise and found a strong association between self-efficacy and exercise in PD patients, rather than disability .
Researchers suggest that social cognitive theory (SCT) constructs are important correlates of physical activity for PD patients and should be targeted in interventions. A more comprehensive study of SCT correlates - Self-Efficacy (SE), Outcome Expectations (OE), and Self-Regulation (SR) should provide a better understanding of the factors that contribute to physical activity participation and the physical activity / health-related quality of life relationship in PD patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The investigators are using a cross-sectional experimental design of 404 geographically diverse Parkinson's participants. Physiologic (Hoehn & Yahr) and psychological (surveys and single-item measures) measures will be collected via web-based surveys in Qualtrics accessed through a link.
Sample Using (Fritz & MacKinnon, 2007) article on the required sample size necessary to detect mediated effects, using the empirical estimates in Table 3 for the Baron and Kenny test with ť = .59, α = .59 and β = .14, the desired sample size needed for a power of .8 would be 404. In this population, the investigators expect that some PD participants may start the survey and be unable to finish. For this reason, the investigators would like to oversample by 25% with a target of 505 participants.
Description
Inclusion Criteria:
- English speaking
- Parkinson's disease diagnosed by a neurologist
Exclusion Criteria:
- Atypical Parkinson's
- Supranuclear Palsy
- Deep Brain Stimulation (DBS) or other brain surgery
- Not living independently (living in assisted-living or skilled-nursing facility)
- Spouse or caregiver responding instead of PD participant
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Idiopathic Parkinson's Patients
Patients with idiopathic parkinson's disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health-Related Quality of Life (HRQoL) correlation to self-reported physical activity (PA)
Time Frame: participant's respond to survey questions only 1 time
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multiple linear regression analysis will be used to determine if higher HRQoL is significantly related to self-reported physical activity in PD patients.
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participant's respond to survey questions only 1 time
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-efficacy (SE), Outcomes Expectations (OE), and Self-Regulation (SR) correlation to self-reported HRQoL
Time Frame: Outcomes as measured at a single baseline assessment
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multiple linear regression analysis will be used to determine if higher levels of SE, OE, and SR are significantly related to self-reported HRQoL.
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Outcomes as measured at a single baseline assessment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Social Cognitive Theory (SCT) constructs as mediators between self-reported PA and HRQoL
Time Frame: Outcomes as measured at a single baseline assessment
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hierarchical linear regression model will be used to examine the SCT constructs as potential mediators between self-reported PA and HRQoL in PD patients.
Also, any variables determined to have significant impact in the multiple regression models will be controlled for in the HLM, allowing us to investigate the effects of certain variables while controlling for the effects of others.
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Outcomes as measured at a single baseline assessment
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SCT constructs correlation to self-reported PA
Time Frame: Outcomes as measured at a single baseline assessment
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multiple linear regression analysis will then be used to examine the relationship between the social cognitive theory constructs and self-reported physical activity in PD patients.
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Outcomes as measured at a single baseline assessment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian C Focht, PhD, Associate Professor Kinesiology
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015B0259
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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