Clinical trial NCT05575479: PA Behavior and HRQoL in Parkinson's Disease Patients Patients: Role of Social Cognitive Variables
Official title: Physical Activity Behavior and Health-Related Quality of Life in Parkinson's Disease Patients: Role of Social Cognitive Variables
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Idiopathic Parkinson Disease
Idiopathic Parkinson's Disease
Parkinson Disease, Idiopathic
Parkinson's Disease
Parkinson's Disease, Idiopathic
Keywords: Social Cognitive Theory
Physical Activity
Quality of Life
Parkinsons
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-Related Quality of Life (HRQoL) correlation to self-reported physical activity (PA)
timeFrame: participant's respond to survey questions only 1 time
Secondary outcomes:
measure: Self-efficacy (SE), Outcomes Expectations (OE), and Self-Regulation (SR) correlation to self-reported HRQoL
timeFrame: Outcomes as measured at a single baseline assessment
Other outcomes:
measure: Social Cognitive Theory (SCT) constructs as mediators between self-reported PA and HRQoL
timeFrame: Outcomes as measured at a single baseline assessment
measure: SCT constructs correlation to self-reported PA
timeFrame: Outcomes as measured at a single baseline assessment
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Associate Professor Kinesiology
name: Brian C Focht, PhD
role: PRINCIPAL_INVESTIGATOR
References: