Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616948
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
In-home Cycling for Individuals With PD Effectiveness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examining the Reach Effectiveness and Maintenance of Social Engagement on Exercise Outcomes In-home Cycling for Individuals With Parkinson Disease
Status:
ACTIVE_NOT_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:
None
Brief Summary:
This study seeks to examine the reach and maintenance of an in-home cycling program for underserved individuals with Parkinson disease and to determine the effectiveness of a 6-month in-home progressive tele-exercise cycling program and 3-month health coach follow-up for those same participants
Detailed Description:
The benefits of exercise for individuals with Parkinson disease PD have been well documented however individuals with PD living in rural and underserved urban settings are largely unable or unwilling to participate in group exercise programs due in large part to their distance from such programs and financial considerations Additionally community based programs which provide social support and engagement have been shown to benefit elderly individuals as well as individuals with pathology but are equally unattainable to this group Taking the exercise to these individuals via telemedicine or tele-exercise may be an ideal means of delivering this type of intervention
The long-term goal of this project is to improve outcomes for underserved populations of individuals with Parkinson disease PD by providing access to in-home physical activity via a telehealth approach Approximately one million Americans currently live with a diagnosis of PD and it has been estimated that delaying the progression by 20 would result in a 75891 savings per individual based on reduced health care costs income maintenance increased duration of life and improved quality of life However individuals with PD of lower socioeconomic status people of color and rural dwelling seniors have been critically underserved by clinical and academic programming resulting in poorer health outcomes
This study examines 1 the Reach Effectiveness Implementation and Maintenance and 2 the optimal delivery method for an in-home exercise intervention program for individuals with PD living in underserved communities A managed and meaningful exercise intervention will be delivered that not only addresses the benefits of physical activity for individuals with PD but also offers a social connection to research staff outside of the participants typical caregivers
SPECIFIC AIM 1 Examine the reach and maintenance of an in-home cycling program for underserved individuals with PD Reach will be assessed by examining the demographic characteristics of the individuals enrolled and through the administration of a questionnaire on objective and subjective socioeconomic status to better understand their level of accessibility to services perceived barriers and economic status The investigators will also explore the implementation of a health coach to promote effective maintenance of the program after the 6-month intervention Finally two interviews will be conducted to better understand strengths and weakness of the program and to better address the needs of the participants in future studies
Hypothesis 1a Demographic characteristics including race and socioeconomic status of the enrolled participants will not statistically differ from the characteristics of the state of WI
Hypothesis 1b Feedback from participant interviews will inform future delivery of the in-home cycling program
SPECIFIC AIM 2 Determine the effectiveness of a 6-month in-home progressive tele-exercise cycling program and 3-month health coach follow-up for underserved populations of individuals with PD
Hypothesis 2a Participants will improve performance of activities of daily living from baseline to posttest These effects will be maintained at 3-month follow-up
Hypothesis 2b Participants will significantly improve measures of gait and balance performance and non- significantly improve fall rate from baseline to posttest These effects will be maintained at 3-month follow-up in the group piloting implementation of a health coach but not in solo follow-up group Falls data will allow for effect size calculations for future applications
Hypothesis 2c Activity level as measured by an activity monitor will increase from baseline to posttest This effect will be maintained at 3-month follow-up in health coach group but not in the solo group
Study Design 40 qualified individuals will be paired based on disease severity score on subsection III of the UPDRS and age and randomly assigned to either the cycling group or the normal care control group for 6 months For those in the cycling group participants will interact via Skype with study team members during all cycling sessions This intervention will allow the individuals enrolled to participate in regular exercise and a community activity that promotes social support and engagement The proposed pilot maintenance model for the 3-month period following the intervention will implement a health coach model with scheduled sessions every other week to discuss goals and motivation while decreasing the total contact time with the participant Individuals in the normal care control group will crossover and complete the cycling intervention following the initial 6 months
The long-term goal of this project is to improve outcomes for underserved populations of individuals with Parkinson disease PD by providing access to in-home physical activity via a telehealth approach Approximately one million Americans currently live with a diagnosis of PD and it has been estimated that delaying the progression by 20 would result in a 75891 savings per individual based on reduced health care costs income maintenance increased duration of life and improved quality of life However individuals with PD of lower socioeconomic status people of color and rural dwelling seniors have been critically underserved by clinical and academic programming resulting in poorer health outcomes
This study examines 1 the Reach Effectiveness Implementation and Maintenance and 2 the optimal delivery method for an in-home exercise intervention program for individuals with PD living in underserved communities A managed and meaningful exercise intervention will be delivered that not only addresses the benefits of physical activity for individuals with PD but also offers a social connection to research staff outside of the participants typical caregivers
SPECIFIC AIM 1 Examine the reach and maintenance of an in-home cycling program for underserved individuals with PD Reach will be assessed by examining the demographic characteristics of the individuals enrolled and through the administration of a questionnaire on objective and subjective socioeconomic status to better understand their level of accessibility to services perceived barriers and economic status The investigators will also explore the implementation of a health coach to promote effective maintenance of the program after the 6-month intervention Finally two interviews will be conducted to better understand strengths and weakness of the program and to better address the needs of the participants in future studies
Hypothesis 1a Demographic characteristics including race and socioeconomic status of the enrolled participants will not statistically differ from the characteristics of the state of WI
Hypothesis 1b Feedback from participant interviews will inform future delivery of the in-home cycling program
SPECIFIC AIM 2 Determine the effectiveness of a 6-month in-home progressive tele-exercise cycling program and 3-month health coach follow-up for underserved populations of individuals with PD
Hypothesis 2a Participants will improve performance of activities of daily living from baseline to posttest These effects will be maintained at 3-month follow-up
Hypothesis 2b Participants will significantly improve measures of gait and balance performance and non- significantly improve fall rate from baseline to posttest These effects will be maintained at 3-month follow-up in the group piloting implementation of a health coach but not in solo follow-up group Falls data will allow for effect size calculations for future applications
Hypothesis 2c Activity level as measured by an activity monitor will increase from baseline to posttest This effect will be maintained at 3-month follow-up in health coach group but not in the solo group
Study Design 40 qualified individuals will be paired based on disease severity score on subsection III of the UPDRS and age and randomly assigned to either the cycling group or the normal care control group for 6 months For those in the cycling group participants will interact via Skype with study team members during all cycling sessions This intervention will allow the individuals enrolled to participate in regular exercise and a community activity that promotes social support and engagement The proposed pilot maintenance model for the 3-month period following the intervention will implement a health coach model with scheduled sessions every other week to discuss goals and motivation while decreasing the total contact time with the participant Individuals in the normal care control group will crossover and complete the cycling intervention following the initial 6 months
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