Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease

NCT06603012 | Not Yet Recruiting

• 2 other identifiers: STUDY2024-1038P30AG022849
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson disease; Parkinsonian disorders; Movement disorders; Basal ganglia diseases; Brain diseases; Nervous system diseases; Central nervous system diseases; Neurodegenerative diseases; Cognition; Walking; Exercise; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Physical Activity

  ActiGraph Gt3X+ accelerometer; minutes spent in light physical activity per day

  Changes in time spent in light physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)

• Physical Activity

  ActiGraph Gt3X+ accelerometer; minutes spent in moderate-to-vigorous physical activity per day

  Changes in time spent in moderate-to-vigorous physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)

Secondary Outcomes (7)

• Cognitive Function

  Changes in SCOPA-Cog Baseline (pre-intervention) to after 16 weeks (post-intervention)

• Fatigue Severity

  Changes in fatigue severity scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)

• Depressive Symptoms

  Changes in depressive symptoms scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)

• Fatigue Impact

  Changes in fatigue impact scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)

• Anxiety

  Changes in anxiety scores from Baseline (pre-intervention) to after 16 weeks (post-intervention

Other Outcomes (6)

• Social Cognitive Theory

  Changes in exercise self-efficacy from Baseline (pre-intervention) to after 16 weeks (post-intervention)

• Social Cognitive Theory

  Changes in barriers for self-efficacy from Baseline (pre-intervention) to after 16 weeks (post-intervention)

• Social Cognitive Theory

  Changes in exercise goal setting from Baseline (pre-intervention) to after 16 weeks (post-intervention)

Study Arms (2)

GET Up PD

EXPERIMENTAL

Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training

Behavioral: GET Up PD

Stretching and Flexibility

ACTIVE COMPARATOR

Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training

Behavioral: Stretching and Flexibility

Interventions

Stretching and Flexibility BEHAVIORAL

* The training will involve the same frequency, duration, timeline, behavior change content, and interactions with behavioral coach as the GET Up PD program, and account for activity, social-contact, and attention. * Other components of the Stretching and Flexibility program include appropriate exercise equipment (yoga mat), one-on-one coaching sessions via Zoom, calendars, logbooks and newsletters similar to the GET Up PD program.

Stretching and Flexibility

GET Up PD BEHAVIORAL

* The exercise training prescription involves performing 3 days per week and include (a) aerobic exercise: 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and (b) resistance training: 1-3 sets, 8-12 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands. * Other components of the GET Up PD program include appropriate exercise equipment (pedometer, resistance bands), one-on-one coaching sessions via Zoom, action-planning via calendars, logbooks for self-monitoring, and SCT-based newsletters.

GET Up PD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Movement Disorders; Basal Ganglia Diseases; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Motor Activity

Interventions

Pliability

Condition Hierarchy (Ancestors)

Synucleinopathies; Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Robert Motl, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Jeng, PhD

CONTACT

312-996-6615; enrl@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)