Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712395
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-01-25
Brief Title:
The Effects of a Novel Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
The Effects of a Novel Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
NICE
Brief Summary:
This study is a 3-month prospective randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise NICE program to improve exercise and vascular outcome measures in patients with peripheral artery disease PAD
Detailed Description:
Specific Aims The investigator proposes to test our central hypothesis that the NICE intervention performed without inducing leg ischemia and its damaging sequela will be a superior exercise paradigm to increase peak walking time and HRQoL more than the Standard ischemic and painful exercise paradigm via greater improvement in microvascular mechanisms This clinically relevant hypothesis will be tested through the following aims
Aim 1 Exercise Outcomes To compare the changes in ambulation and HRQoL in PAD patients randomized to either the NICE slow walking program or to the Standard program of ischemic and painful exercise
Aim 2a Vascular Outcomes To compare the changes in local microvascular function of the lower extremities inflammation and oxidative stress in patients following the NICE program and following the Standard ischemic and painful program
Aim 2b Exploratory Aim To explore whether the changes in local microvascular function and systemic vascular biomarkers are associated with the changes in peak walking time following the NICE and Standard programs and whether the association is stronger following the NICE program
Methods This is a 3-month patient-oriented translational comparative effectiveness randomized controlled trial One-hundred patients will be randomized into either the NICE program N50 or the Standard exercise program N50 All patients will perform supervised treadmill walking for 3 months Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 14 mph for only 2-3 minute bouts that do not elicit claudication pain Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain
Aim 1 Exercise Outcomes To compare the changes in ambulation and HRQoL in PAD patients randomized to either the NICE slow walking program or to the Standard program of ischemic and painful exercise
Aim 2a Vascular Outcomes To compare the changes in local microvascular function of the lower extremities inflammation and oxidative stress in patients following the NICE program and following the Standard ischemic and painful program
Aim 2b Exploratory Aim To explore whether the changes in local microvascular function and systemic vascular biomarkers are associated with the changes in peak walking time following the NICE and Standard programs and whether the association is stronger following the NICE program
Methods This is a 3-month patient-oriented translational comparative effectiveness randomized controlled trial One-hundred patients will be randomized into either the NICE program N50 or the Standard exercise program N50 All patients will perform supervised treadmill walking for 3 months Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 14 mph for only 2-3 minute bouts that do not elicit claudication pain Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG071778-01A1 | NIH | None | httpsreporternihgovquickSearchR01AG071778-01A1 |