Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603012
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Behavioral Intervention for Lifestyle Physical Activity in Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Behavioral Intervention for Lifestyle Physical Activity in Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LifePD
Brief Summary:
We 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 Parkinsons disease PD Participants N50 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 participant39s homecommunity and supported by Zoom-based chats guided by SCT via a behavioral coach Participants will receive training materials eg prescriptive manual and exercise equipment one-on-one coaching action-planning via calendars self-monitoring via logs and SCT-based newsletters We hypothesize that the home-based exercise intervention will yield improvements in cognitive symptomatic and QOL outcomes
Detailed Description:
Parkinsons 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 ie loss of driving ability social isolation and lack of community integration that are common in PD We believe that there is merit in the promotion of physical activity for managing cognitive dysfunction and other symptom and QOL outcomes in PD We offer a novel and innovative approach for promotion of physical activity in PD based on our extensive experiences from Phase I II and III randomized controlled trials RCTs Those RCTs indicate that our remotely-delivered social-cognitive theory-based behavioral intervention has successfully increased self-reported and device-measured physical activity in persons with multiple sclerosis MS Our approach has further resulted in improvements in cognition and walking outcomes symptoms of fatigue depression anxiety and pain and QOL among persons with MS We leverage our 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 We 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None