## Protocol Section
### Identification Module
**NCT ID:** NCT05575479

**Acronym:** PDQ

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2015B0259
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University
### Status Module
#### Completion Date
**Date:** 2015-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-12

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-10

**Type:** ACTUAL

#### Start Date
**Date:** 2015-08

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2022-10-12
**Type:** ACTUAL
**Study First Submit Date:** 2015-09-14
**Study First Submit QC Date:** 2022-10-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ohio State University

#### Responsible Party

**Investigator Affiliation:** Ohio State University

**Investigator Full Name:** Brian Focht

**Investigator Title:** Associate Professor of Kinesiology Department of Human Sciences

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 500

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with idiopathic parkinson's disease

**Label:** Idiopathic Parkinson's Patients

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Social Cognitive Theory (SCT) constructs as mediators between self-reported PA and HRQoL

**Time Frame:** Outcomes as measured at a single baseline assessment

**Description:** 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.

**Measure:** SCT constructs correlation to self-reported PA

**Time Frame:** Outcomes as measured at a single baseline assessment

#### Primary Outcomes

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

**Measure:** Health-Related Quality of Life (HRQoL) correlation to self-reported physical activity (PA)

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

#### Secondary Outcomes

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

**Measure:** 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

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Columbus

**Country:** United States

**Facility:** The Ohio State University

**State:** Ohio

**Zip:** 43210

#### Overall Officials

**Official 1:**

**Affiliation:** Associate Professor Kinesiology

**Name:** Brian C Focht, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Qualtrics Survey Study Link

**URL:** http://tinyurl.com/p5h58to

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Misc Info Module

- Version Holder: 2024-05-24
