Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003855
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-07-25
Brief Title:
Oxygen-guided Supervised Exercise Therapy
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease
Status:
RECRUITING
Status Verified Date:
2023-10
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:
MOMET
Brief Summary:
Peripheral artery disease PAD is a cardiovascular disease manifesting from systemic atherosclerosis which blocks the leg arteries and results in insufficient blood flow to the lower extremities Limb ischemia from PAD is the most common disorder treated within the vascular surgery service at the Omaha Veterans Affairs Medical Center PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide This project aims to establish the feasibility and acceptability of a muscle oxygen-guided supervised exercise program for patients with PAD The investigators will determine the potential benefits of using this intervention over standard supervised exercise therapy This modified intervention may enable patients to increase overall physical activity without the negative impacts on muscle structure and function Increasing physical activity will decrease cardiovascular morbidity and mortality If proven beneficial the findings will lead to an improved exercise program that directly benefits veterans nationwide
Detailed Description:
The long-term goal of this research is to improve mobility functional independence and quality of life in patients with peripheral artery disease PAD by developing conservative interventions PAD is a manifestation of atherosclerosis which produces blockages in the leg arteries and results in insufficient blood flow to the legs PAD results in significant gait deficits and an overall sedentary lifestyle The investigators prior work showed that the biochemical oxidative stress and mitochondrial dysfunction and histological myofiber degeneration and fibrosis characteristics of PAD muscles are altered compared to controls These myopathic changes are due to cycles of ischemia and reperfusion and they correlate to functional limitations walking distance and calf muscle strength Limb ischemia from PAD is the most common disorder treated within the vascular surgery service of the Omaha Veterans Affairs Medical Center The most effective treatment for increasing the distances that patients with PAD can walk is supervised exercise therapy SET However SET uses pain onset to guide exercise intensity and rest cycles These repeated bouts of ischemiareperfusion could cause further pathological damage to muscle myofibers and oxidative processes Such adverse effects of ischemia may explain why not all patients improve with SET Preventing cycles of ischemia-reperfusion during SET can improve walking performance without further muscle biochemistry damage in patients with PAD The investigators propose using hemodynamic responses to modulate exercise intensity and prevent ischemia during SET Muscle oxygen-guided supervised exercise therapy M-SET can prevent ischemia onset and thus preserve muscle mass and function during exercise therapy in patients with PAD The aims are
Aim 1 To determine the exercise outcomes of an M-SET versus a standard SET session in patients with PAD Aim 2 To determine the acute effect of M-SET versus standard SET on oxidative stress and inflammation in patients with PAD Aim 3 To determine the effect of 12 weeks of M-SET versus standard SET on exercise outcomes muscle biochemistry and subject-reported preference in patients with PAD
The investigators will measure exercise outcomes during one session each of M-SET using StO2 on the calf to modulate exercise and SET in 12 patients with PAD using a cross-over design Exercise outcomes will be assessed by the total distance patients walked during the session metabolic cost metabolic equivalents of the task physical activity enjoyment and rate of perceived exertion In Aim 2 oxidative stress will be measured using peripheral blood mononuclear cells before and after each exercise session SET and M-SET in all patients During the standard SET session subjects will walk until claudication pain becomes severe and the participant needs to stop Then subjects will rest until claudication pain subsides Afterward subjects will walk again repeating the cycle for up to 50 minutes M-SET will use an StO2 threshold that is 15 lower level than baseline StO2 levels Subjects will stop walking once they reach the threshold and rest until StO2 levels return to baseline Then subjects will begin walking again repeating this cycle for 50 total minutes including walking and rest Patients from Aims 1 and 2 will be randomly assigned to either a 12-week M-SET or standard SET 6 per group program Training will be performed three times weekly as described above Subjects will be evaluated before and after the intervention to capture initial and absolute walking distances and 7-day physical activity Muscle biochemistry will be quantified using mitochondrial function mitochondrial oxidative dynamics and reactive oxygen species production before and after training Results will support a full clinical trial and rehabilitation recommendations
Aim 1 To determine the exercise outcomes of an M-SET versus a standard SET session in patients with PAD Aim 2 To determine the acute effect of M-SET versus standard SET on oxidative stress and inflammation in patients with PAD Aim 3 To determine the effect of 12 weeks of M-SET versus standard SET on exercise outcomes muscle biochemistry and subject-reported preference in patients with PAD
The investigators will measure exercise outcomes during one session each of M-SET using StO2 on the calf to modulate exercise and SET in 12 patients with PAD using a cross-over design Exercise outcomes will be assessed by the total distance patients walked during the session metabolic cost metabolic equivalents of the task physical activity enjoyment and rate of perceived exertion In Aim 2 oxidative stress will be measured using peripheral blood mononuclear cells before and after each exercise session SET and M-SET in all patients During the standard SET session subjects will walk until claudication pain becomes severe and the participant needs to stop Then subjects will rest until claudication pain subsides Afterward subjects will walk again repeating the cycle for up to 50 minutes M-SET will use an StO2 threshold that is 15 lower level than baseline StO2 levels Subjects will stop walking once they reach the threshold and rest until StO2 levels return to baseline Then subjects will begin walking again repeating this cycle for 50 total minutes including walking and rest Patients from Aims 1 and 2 will be randomly assigned to either a 12-week M-SET or standard SET 6 per group program Training will be performed three times weekly as described above Subjects will be evaluated before and after the intervention to capture initial and absolute walking distances and 7-day physical activity Muscle biochemistry will be quantified using mitochondrial function mitochondrial oxidative dynamics and reactive oxygen species production before and after training Results will support a full clinical trial and rehabilitation recommendations
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?:
False
Is an FDA AA801 Violation?:
None