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NCT06603012
Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease
Conditions: Parkinson Disease (PD)
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: University of Illinois at Chicago
Location: University of Illinois at Chicago Chicago Illinois
Summary
The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\'s home/community and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.
Eligibility Criteria
Inclusion Criteria:
* confirmed diagnosis of PD
* Internet and email access
* willingness to complete the cognitive assessments and questionnaires, wear the accelerometer, and undergo randomization
* insufficient physical activity (i.e., not meeting current physical activity guidelines) based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire
* self-reported ability to ambulate without assistance
* age of 50+ years
* English as a primary language
* asymptomatic (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire \[PAR-Q\]) or physician approval for undertaking exercise training for those with 2 or more affirmatives on the PAR-Q
Exclusion Criteria:
* above inclusion criteria not met
* moderate or high risk of contraindications for possible injury or death when undertaking strenuous or maximal exercise using the PAR-Q
* severe cognitive impairment that might preclude compliance with the conditions based on a modified Telephone Interview for Cognitive Status (TICS-M) score of less than 18
* normal cognitive impairment based on the Montreal Cognitive Assessment (MoCA) score of 26 or more for avoiding ceiling effects involving change in cognitive function
Source: ClinicalTrials.gov (NCT06603012). StuddyBuddy aggregates publicly available trial information.
