NCT05575479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
7 years until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

September 14, 2015

Last Update Submit

October 10, 2022

Conditions

Keywords

Social Cognitive TheoryPhysical ActivityQuality of LifeParkinsons

Outcome Measures

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.

    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

    Outcomes as measured at a single baseline assessment

Other Outcomes (2)

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

    Outcomes as measured at a single baseline assessment

  • SCT constructs correlation to self-reported PA

    Outcomes as measured at a single baseline assessment

Study Arms (1)

Idiopathic Parkinson's Patients

Patients with idiopathic parkinson's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • English speaking
  • Parkinson's disease diagnosed by a neurologist

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Brian C Focht, PhD

    Associate Professor Kinesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Kinesiology Department of Human Sciences

Study Record Dates

First Submitted

September 14, 2015

First Posted

October 12, 2022

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations