Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05612945
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2022-10-31
Brief Title:
High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Patients With PAD
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Short-duration Aerobic High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Symptomatic Patients With Peripheral Artery Disease A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
HIIT_PAD
Brief Summary:
Supervised exercise training SET is considered among first-line therapies for patients with symptomatic lower extremity peripheral artery disease PAD combined with general cardiovascular risk management lifestyle adaptation and pharmacological treatment
Although without clear consistency the guidelines give recommendations in terms of claudication pain severity SET volume duration and frequency However no or little guidance is offered as far as training intensity is concerned Most of the previous studies on SET in the context of PAD did not distinguish between symptom intensity and common training intensity measures such as of maximal heart rate HRmax of HR reserve HRR of peak oxygen uptake VO2peak of VO2 reserve VO2R or the rate of perceived exertion RPE
In a recent meta-analysis we demonstrated that both training modality and exercise intensity based on peak heart rate peak oxygen uptake or the rate of perceived exertion should be considered when looking for the best results in patients with symptomatic PAD These results call for study of the individual roles of each exercise intensity and modality on walking performance and cardiorespiratory fitness in patients with symptomatic PAD
High-intensity interval training HIIT is composed of brief bursts of vigorous intensity interspersed with periods of rest or low-intensity exercise HIIT may be better than moderate-intensity training MIT in improving cardiorespiratory fitness and functional capacity in patients with cardiovascular and metabolic diseases but in patients with symptomatic PAD the effects of such modalities on walking ability and cardiorespiratory fitness remain to be clearly determined
The primary objective of this study is to compare the effects of 12-week-long exercise training short-duration high-intensity intervals vs low-to-moderate intensity on treadmill performance in patients with symptomatic PAD
It is hypothesized that treadmill performance would be improved to a greater extent after high-intensity exercise training
Although without clear consistency the guidelines give recommendations in terms of claudication pain severity SET volume duration and frequency However no or little guidance is offered as far as training intensity is concerned Most of the previous studies on SET in the context of PAD did not distinguish between symptom intensity and common training intensity measures such as of maximal heart rate HRmax of HR reserve HRR of peak oxygen uptake VO2peak of VO2 reserve VO2R or the rate of perceived exertion RPE
In a recent meta-analysis we demonstrated that both training modality and exercise intensity based on peak heart rate peak oxygen uptake or the rate of perceived exertion should be considered when looking for the best results in patients with symptomatic PAD These results call for study of the individual roles of each exercise intensity and modality on walking performance and cardiorespiratory fitness in patients with symptomatic PAD
High-intensity interval training HIIT is composed of brief bursts of vigorous intensity interspersed with periods of rest or low-intensity exercise HIIT may be better than moderate-intensity training MIT in improving cardiorespiratory fitness and functional capacity in patients with cardiovascular and metabolic diseases but in patients with symptomatic PAD the effects of such modalities on walking ability and cardiorespiratory fitness remain to be clearly determined
The primary objective of this study is to compare the effects of 12-week-long exercise training short-duration high-intensity intervals vs low-to-moderate intensity on treadmill performance in patients with symptomatic PAD
It is hypothesized that treadmill performance would be improved to a greater extent after high-intensity exercise training
Detailed Description:
Lower extremity peripheral artery disease PAD affects more than 200 million people worldwide PAD is characterized by atherosclerotic lumen narrowing or occlusion of the lower limb arteries leading to an imbalance between oxygen supply and demand downstream especially in activated muscle during exertion The hallmark symptom of PAD is typical intermittent claudication defined as reproducible exertion-induced cramping or pain in the lower extremities which is rapidly relieved with rest
Patients with symptomatic PAD avoid exertion and tend to have muscle weakness an altered gait and lower limb biomechanics This results in impaired walking performance accelerated functional decline and reduced quality of life
Supervised exercise training SET is considered among first-line therapies for patients with symptomatic PAD combined with general cardiovascular risk management lifestyle adaptation and pharmacological treatment The clinical benefits of SET for patients with PAD are well established with improved walking capacity and an improved quality of life as the primary outcomes
Although without clear consistency the guidelines give recommendations in terms of claudication pain severity SET volume duration and frequency However no or little guidance is offered as far as training intensity is concerned Most of the previous studies on SET in the context of PAD did not distinguish between symptom intensity and common training intensity measures such as of maximal heart rate HRmax of HR reserve HRR of peak oxygen uptake VO2peak of VO2 reserve VO2R or the rate of perceived exertion RPE
A meta-analysis by Parmenter et al showed that vigorous HRpeak 77-96 VO2peak 64-90 RPE 14-17 exercise training improved cardiorespiratory fitness VO2peak more than light- to-moderate exercise therapy intensity in patients with PAD but the changes in walking performance in these patients remain to be determined In a recent meta-analysis we demonstrated that both training modality and exercise intensity based on peak heart rate peak oxygen uptake or the rate of perceived exertion should be considered when looking for the best results in patients with symptomatic PAD More precisely we showed that when training modalities were considered walking at vigorous intensity showed the greatest improvement in maximal walking distance MWD while walking at light-to-moderate intensity showed the greatest improvement in pain-free walking distance We also showed that vigorous was superior to light-to-moderate exercise intensity in improving cardiorespiratory fitness and that when training modalities were considered cycling and other non-walking forms of training performed at vigorous intensity elicited the greatest improvements in cardiorespiratory fitness
The results of our meta-analysis call for study of the individual roles of each exercise intensity and modality on walking performance and cardiorespiratory fitness in patients with symptomatic PAD
High-intensity interval training HIIT is composed of brief bursts of vigorous intensity interspersed with periods of rest or low-intensity exercise HIIT may be better than moderate-intensity training MIT in improving cardiorespiratory fitness and functional capacity in patients with cardiovascular and metabolic diseases but in patients with symptomatic PAD the effects of such modalities on walking ability and cardiorespiratory fitness remain to be clearly determined
The primary objective of this study is to compare the effects of 12-week-long exercise training short-duration high-intensity intervals vs low-to-moderate intensity on treadmill performance in patients with symptomatic PAD
It is hypothesized that treadmill performance would be improved to a greater extent after high-intensity exercise training
Patients with symptomatic PAD avoid exertion and tend to have muscle weakness an altered gait and lower limb biomechanics This results in impaired walking performance accelerated functional decline and reduced quality of life
Supervised exercise training SET is considered among first-line therapies for patients with symptomatic PAD combined with general cardiovascular risk management lifestyle adaptation and pharmacological treatment The clinical benefits of SET for patients with PAD are well established with improved walking capacity and an improved quality of life as the primary outcomes
Although without clear consistency the guidelines give recommendations in terms of claudication pain severity SET volume duration and frequency However no or little guidance is offered as far as training intensity is concerned Most of the previous studies on SET in the context of PAD did not distinguish between symptom intensity and common training intensity measures such as of maximal heart rate HRmax of HR reserve HRR of peak oxygen uptake VO2peak of VO2 reserve VO2R or the rate of perceived exertion RPE
A meta-analysis by Parmenter et al showed that vigorous HRpeak 77-96 VO2peak 64-90 RPE 14-17 exercise training improved cardiorespiratory fitness VO2peak more than light- to-moderate exercise therapy intensity in patients with PAD but the changes in walking performance in these patients remain to be determined In a recent meta-analysis we demonstrated that both training modality and exercise intensity based on peak heart rate peak oxygen uptake or the rate of perceived exertion should be considered when looking for the best results in patients with symptomatic PAD More precisely we showed that when training modalities were considered walking at vigorous intensity showed the greatest improvement in maximal walking distance MWD while walking at light-to-moderate intensity showed the greatest improvement in pain-free walking distance We also showed that vigorous was superior to light-to-moderate exercise intensity in improving cardiorespiratory fitness and that when training modalities were considered cycling and other non-walking forms of training performed at vigorous intensity elicited the greatest improvements in cardiorespiratory fitness
The results of our meta-analysis call for study of the individual roles of each exercise intensity and modality on walking performance and cardiorespiratory fitness in patients with symptomatic PAD
High-intensity interval training HIIT is composed of brief bursts of vigorous intensity interspersed with periods of rest or low-intensity exercise HIIT may be better than moderate-intensity training MIT in improving cardiorespiratory fitness and functional capacity in patients with cardiovascular and metabolic diseases but in patients with symptomatic PAD the effects of such modalities on walking ability and cardiorespiratory fitness remain to be clearly determined
The primary objective of this study is to compare the effects of 12-week-long exercise training short-duration high-intensity intervals vs low-to-moderate intensity on treadmill performance in patients with symptomatic PAD
It is hypothesized that treadmill performance would be improved to a greater extent after high-intensity exercise training
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