University of Illinois at Chicago
Chicago, Illinois, 60612, United States
NCT Number: NCT06603012
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.
Trial opening soon.
Get Notified50 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Parkinson's disease (PD) is a neurodegenerative disorder of the dopamine-producing nerve cells in the basal ganglia, and age is a primary risk factor for PD. Cognitive impairment is prevalent, disabling, and poorly managed among the 1 million adults living with PD in the United States. Indeed, cognitive impairment begins early in PD, and dementia develops in 80% of persons with PD. Cognitive impairment is further associated with worse fatigue, depression, anxiety, pain, and quality of life (QOL) in PD. Those observations underscore the importance of identifying efficacious approaches for managing cognitive impairment and its consequences, and promoting additional health benefits among those with PD. To date, researchers have examined the benefits of supervised, structured exercise training for managing outcomes of PD, but this approach has clear barriers associated with travel, transportation, and participation (i.e., loss of driving ability, social isolation, and lack of community integration) that are common in PD. The investigators believe that there is merit in the promotion of physical activity for managing cognitive dysfunction and other symptom and QOL outcomes in PD. The investigators offer a novel and innovative approach for promotion of physical activity in PD based on their extensive experiences from Phase I, II, and III randomized controlled trials (RCTs). Those RCTs indicate that the remotely-delivered, social-cognitive theory-based behavioral intervention has successfully increased self-reported and device-measured physical activity in persons with multiple sclerosis (MS). This approach has further resulted in improvements in cognition and walking outcomes, symptoms of fatigue, depression, anxiety, and pain, and QOL among persons with MS. The investigators leverage their experiences and preliminary results in MS, and propose a Stage-I RCT that examines the feasibility and efficacy of a remotely-delivered, theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding immediate improvements in device-measured physical activity (primary outcome) among persons with PD who are physically inactive. The investigators further examine the efficacy of this behavioral intervention for improvements in cognitive function, symptoms, and QOL (secondary outcomes). The proposed study, if successful, will provide experiences and pilot data necessary for the design of a subsequent Stage-II RCT that examines the efficacy of the behavioral intervention for immediate and sustained improvements of outcomes in an appropriately-powered and clearly-demarcated sample of adults with PD (i.e., those 50+ years of age who are prescreened for cognitive impairment). This line of research may yield "real-world" guidelines for physical activity that can be implemented for the treatment of cognitive dysfunction and other outcomes in PD. Such an opportunity for rehabilitation of cognitive function using an approach with broad reach and scalability is paramount considering the prevalent, disabling, and poorly managed nature of cognitive impairment in PD and limited efficacious resources for its treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Changes in time spent in light physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)
ActiGraph Gt3X+ accelerometer; minutes spent in light physical activity per day
Time frame: Changes in time spent in moderate-to-vigorous physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)
ActiGraph Gt3X+ accelerometer; minutes spent in moderate-to-vigorous physical activity per day
Time frame: Changes in SCOPA-Cog Baseline (pre-intervention) to after 16 weeks (post-intervention)
SCales for Outcomes in PArkinson's disease - COGnition (SCOPA-Cog); scores range between 0-43, higher scores indicate better cognitive function
Time frame: Changes in fatigue severity scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity
Time frame: Changes in depressive symptoms scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Time frame: Changes in fatigue impact scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores reflect a greater impact of fatigue on daily life
Time frame: Changes in anxiety scores from Baseline (pre-intervention) to after 16 weeks (post-intervention
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Time frame: Changes in perceived pain from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Short-form McGill Pain Questionnaire (SF-MPQ); scores range between 0 and 45, higher scores indicate more perceived pain
Time frame: Changes in SF-36 scores from Baseline (pre-intervention), after 16 weeks (post-intervention)
Short Form Health Status Survey (SF-36); scores range between 0 (min) and 100 (max), higher scores indicate better physical and mental aspects of quality of life
Time frame: Changes in exercise self-efficacy from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Exercise Self-Efficacy Scale (EXSE); scores range between 0 (not at all confident) to 100 (completely confident), higher scores indicate more self-efficacy
Time frame: Changes in barriers for self-efficacy from Baseline (pre-intervention) to after 16 weeks (post-intervention)
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
Time frame: Changes in exercise goal setting from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Exercise Goal Setting (EGS); scores range between 0 and 50, higher scores indicate stronger tendency to set goals
Time frame: Changes in exercise planning from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Exercise Planning (EPS); scores range between 0 and 50, higher scores indicate stronger tendency to make plans to engage in exercise and physical activity
Time frame: Changes in outcome expectations from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Multidimensional Outcome Expectations for Exercise Scale (MOEES), higher scores indicate greater perceptions of positive benefits of regular exercise and physical activity
Time frame: Changes in perceived social support for self-efficacy from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Social Provisions Scale (SPS); scores range between 6 and 24, higher scores indicate more perceived support
Contact information is provided by the study sponsor or research team.
University of Illinois at Chicago
Other
Acronym: LifePD
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