Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961943
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-07-10
Brief Title:
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
Sponsor:
National Institute for Prevention and Cardiovascular Health Ireland
Organization:
National Institute for Prevention and Cardiovascular Health Ireland
Study Overview
Official Title:
Feasibility Acceptability and Outcomes of the RESPONSE-2 Program in Reducing Sedentary Behavior in Patients With Peripheral Arterial Disease A Mixed Methods Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The RESPONSE-2- peripheral arterial disease PAD program will be implemented to modify sedentary time in patients with PAD It is an adapted version of the RESPONSE that aims to reduce sedentary behavior in individuals with diabetes The RESPONSE-2-PAD is a multicomponent program involves an online educational component sedentary reminders and health coaching sessions which are designed to modify patients sedentary behavior
Detailed Description:
Peripheral arterial disease PAD affects more than 230 million patients globally PAD is characterized by a reduction in arterial perfusion caused by atherosclerotic plaque PAD can negatively impact a persons quality of life due to the functional limitations caused by symptoms and the possibility of losing limbs It also increases the risk of major adverse cardiac events MACE Many risk factors have been identified for PAD Recently sedentary behavior SB has emerged as an important risk factor for cardiovascular disease CVD including PAD independent to physical activity
Studies have reported that patients with PAD have significantly higher levels of total sedentary time ST compared to those without PAD Consequently early intervention and management strategies including addressing sedentary behavior are crucial to prevent unfavorable outcomes in patients with established PAD as it is possible for an individual to engage in a significant amount of moderate to vigorous physical activity and have high levels of sedentary time within the same day
The RESPONSE-2-PAD program will be evaluated in a pilot study involving 50 patients living with peripheral arterial disease They will be recruited through the vascular services at University Hospital Galway Those potentially interested will be provided with an information sheet Participants will take part in an initial assessment which will measure their sitting time physical activity participation and their six-minute walking distance They will then take part in a 12-week individually tailored coaching-based intervention This intervention will be delivered remotely The intervention involves the use of an activity trackersedentary reminder and an online structured education program coupled with coaching calls 10-15minutes that review sitting time and activity goals weekly At 12-weeks all participants will be invited to a follow up assessment where sitting time activity participation and six-minute walking distance will be remeasured Patients will also be invited to take part in a semi-structured interview to explore their views and opinions of the program and its acceptability At six months all patients will be invited for a final follow-up measurement of their sitting time physical activity participation and six-minute walking distance in order to evaluate longer term changes
Studies have reported that patients with PAD have significantly higher levels of total sedentary time ST compared to those without PAD Consequently early intervention and management strategies including addressing sedentary behavior are crucial to prevent unfavorable outcomes in patients with established PAD as it is possible for an individual to engage in a significant amount of moderate to vigorous physical activity and have high levels of sedentary time within the same day
The RESPONSE-2-PAD program will be evaluated in a pilot study involving 50 patients living with peripheral arterial disease They will be recruited through the vascular services at University Hospital Galway Those potentially interested will be provided with an information sheet Participants will take part in an initial assessment which will measure their sitting time physical activity participation and their six-minute walking distance They will then take part in a 12-week individually tailored coaching-based intervention This intervention will be delivered remotely The intervention involves the use of an activity trackersedentary reminder and an online structured education program coupled with coaching calls 10-15minutes that review sitting time and activity goals weekly At 12-weeks all participants will be invited to a follow up assessment where sitting time activity participation and six-minute walking distance will be remeasured Patients will also be invited to take part in a semi-structured interview to explore their views and opinions of the program and its acceptability At six months all patients will be invited for a final follow-up measurement of their sitting time physical activity participation and six-minute walking distance in order to evaluate longer term changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None