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CompletedNCT05575479PDQUpdated Oct 12, 2022

PA Behavior and HRQoL in Parkinson's Disease Patients Patients: Role of Social Cognitive Variables

An observational study in Parkinson Disease, Idiopathic Parkinson Disease and Idiopathic Parkinson's Disease, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years and older
Sex
All
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Study summary

The primary aim of the study will be to examine Social Cognitive Theory (SCT) correlates, of physical activity (PA) participation and health-related quality of life (HRQoL) in Parkinson's disease participants.

Read the 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.

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Conditions studied

  • Parkinson Disease
  • Idiopathic Parkinson Disease
  • Idiopathic Parkinson's Disease
  • Parkinson Disease, Idiopathic
  • Parkinson's Disease
  • Parkinson's Disease, Idiopathic

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Keywords

  • Social Cognitive Theory
  • Physical Activity
  • Quality of Life
  • Parkinsons
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 500 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  1. English speaking
  2. Parkinson's disease diagnosed by a neurologist

Exclusion criteria

Exclusion Criteria:

  1. Atypical Parkinson's
  2. Supranuclear Palsy
  3. Deep Brain Stimulation (DBS) or other brain surgery
  4. Not living independently (living in assisted-living or skilled-nursing facility)
  5. Spouse or caregiver responding instead of PD participant
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • Idiopathic Parkinson's Patients

    Patients with idiopathic parkinson's disease

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What researchers measure

Primary outcomes

  1. Health-Related Quality of Life (HRQoL) correlation to self-reported physical activity (PA)

    multiple linear regression analysis will be used to determine if higher HRQoL is significantly related to self-reported physical activity in PD patients.

    Time frame: participant's respond to survey questions only 1 time

Secondary outcomes

  1. Self-efficacy (SE), Outcomes Expectations (OE), and Self-Regulation (SR) correlation to self-reported HRQoL

    multiple linear regression analysis will be used to determine if higher levels of SE, OE, and SR are significantly related to self-reported HRQoL.

    Time frame: Outcomes as measured at a single baseline assessment

Other outcomes

  1. Social Cognitive Theory (SCT) constructs as mediators between self-reported PA and HRQoL

    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.

    Time frame: Outcomes as measured at a single baseline assessment

  2. SCT constructs correlation to self-reported PA

    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.

    Time frame: Outcomes as measured at a single baseline assessment

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Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05575479
Lead sponsor
Ohio State University
Responsible party
Brian Focht (Associate Professor of Kinesiology Department of Human Sciences, Ohio State University) — Principal investigator
First posted
Oct 12, 2022
Start date
Aug 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Oct 12, 2022

Study contacts

Brian C Focht, PhD
principal investigator · Associate Professor Kinesiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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