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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05575479
Other study ID # 2015B0259
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2015
Est. completion date October 2015

Study information

Verified date October 2022
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. English speaking 2. Parkinson's disease diagnosed by a neurologist 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

Study Design


Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. Outcomes as measured at a single baseline assessment
Other 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. Outcomes as measured at a single baseline assessment
Primary 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. participant's respond to survey questions only 1 time
Secondary 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. Outcomes as measured at a single baseline assessment
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