About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
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.
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.
Treatment groups
Trial outcomes
Primary outcomes
Physical Activity
ActiGraph Gt3X+ accelerometer; minutes spent in light physical activity per day
Physical Activity
ActiGraph Gt3X+ accelerometer; minutes spent in moderate-to-vigorous physical activity per day
Secondary outcomes
Cognitive Function
SCales for Outcomes in PArkinson's disease - COGnition (SCOPA-Cog); scores range between 0-43, higher scores indicate better cognitive function
Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity
Depressive Symptoms
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Fatigue Impact
Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores reflect a greater impact of fatigue on daily life
Other outcomes
Social Cognitive Theory
Exercise Self-Efficacy Scale (EXSE); scores range between 0 (not at all confident) to 100 (completely confident), higher scores indicate more self-efficacy
Social Cognitive Theory
Barriers for Self-Efficacy Scale (BARSE); scores range between 0 (Not at all confident) to 100 (Completely confident), higher scores indicate more self-efficacy to overcome barriers to exercise
Social Cognitive Theory
Exercise Goal Setting (EGS); scores range between 0 and 50, higher scores indicate stronger tendency to set goals
Social Cognitive Theory
Exercise Planning (EPS); scores range between 0 and 50, higher scores indicate stronger tendency to make plans to engage in exercise and physical activity
Sponsors and contacts
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University of Illinois at Chicago
Lead sponsor
National Institute on Aging (NIA)
Collaborator
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