Peripheral Arterial DiseaseHIIT_PADNCT05612945
High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Patients With PAD
A study testing High-intensity interval training group (HIIT) and Low-to-moderate intensity training group (LowMod group) in people with Peripheral Arterial Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- High-intensity interval training group (HIIT) and Low-to-moderate intensity training group (LowMod group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with symptomatic PAD (Fontaine stage IIa/b);
- ABI ≤ 0.9 or drop by 20% following exercise treadmill test 1;
- TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency);
- Signed written informed consent form.
Who cannot join
- Age < 18;
- Unable to walk at 3.2 km/h on a treadmill (slope 0%) at least 300 m;
- Previous participate in SET programs ≤ 1 year;
- Prior leg/foot amputation;
- Contraindication to exercise
- Neurological and neuromuscular disorders and other comorbidities (orthopedic, rheumatologic) leading to gait abnormalities.
- Known Pregnancy
- Incapacity of discernment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1011
Lucia Mazzolai, Prof, +41213144700, lucia.mazzolai@chuv.ch
Stefano Lanzi, PhD, +41795564911, stefano.lanzi@chuv.ch
About this study
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
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).
Read more
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
Read the 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
- Conditions
- Peripheral Arterial Disease
- Being tested
- High-intensity interval training group (HIIT), Low-to-moderate intensity training group (LowMod group)
- Keywords
- Exercise, Rehabilitation, Physical activity
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training group (HIIT)Other
Exercise training sessions will consist in an alternation of brief periods (≤ 60 s) of work performed at high intensity and brief period of passive rest.
Patient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. The training intensity in the HIIT group will be set at ≥85% HRpeak recorded during the maximal cardiopulmonary exercise test.
The training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland).
Low-to-moderate intensity training group (LowMod group)Other
Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at ≤76% HRpeak recorded during the maximal cardiopulmonary exercise test.
The training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland).
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training group (HIIT) | Experimental | Exercise training sessions will consist in an alternation of brief periods (≤ 60 s) of work performed at high intensity and brief period of passive rest.
Patient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. This protocol will elicits moderate-to-severe claudication pain during exertion. The training intensity in the HIIT group will be set at ≥85% HRpeak recorded during the maximal cardiopulmonary exercise test. Receives: Other: High-intensity interval training group (HIIT) |
| Low-to-moderate intensity training group (LowMod group) | Experimental | Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at ≤76% HRpeak recorded during the maximal cardiopulmonary exercise test. Receives: Other: Low-to-moderate intensity training group (LowMod group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal walking distance
Patients will perform an incremental treadmill test to determine the maximal walking distance (MWD). Initial walking speed will be set at 3.2 km/h, and at 0% grade. The grade will be increased by 2% each 2 min.
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Secondary outcomes (12)
Functional performance - 6-minute walk test
Patients will perform the 6-minute walk test
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - ascending and descending stair performance test
Patients will perform the ascending and descending stair performance test
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - short physical performance battery test
Patients will perform the short physical performance battery test
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - preferred walking speed and gait analysis assessment
Patients will perform the preferred walking speed and gait analysis assessment
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - unipedal stance test
Patients will perform the unipedal stance test
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - 30- and 60-s repeated sit-to-stand chair test
Patients will perform the 30- and 60-s repeated sit-to-stand chair test.
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Cardiorespiratory fitness (VO2peak)
Patients will perform a maximal cardiopulmonary exercise test
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Muscle oxygenation during treadmill test
Muscle oxygenation will be assessed during treadmill test by near-infrared spectroscopy (NIRS)
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Hemodynamic parameters
Ankle - toe brachial index (ABI, TBI)
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Self-perceived quality of life and walking (dis)abilities
Self-perceived quality of life (Medical Outcomes Study Short-Form 36 (SF-36) and walking (dis)abilities (Walking Impairement Questionnaire, WIQ) will be assessed. Each questionnaire has scores on a 0-100 scale (0 (worse score) to 100 (best score)).
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Total amount of physical activity
The total amount of physical activity will be assessed by accelerometer.
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Pain-free walking distance
Patients will perform an incremental treadmill test to determine the pain-free walking distance (PFWD). Initial walking speed will be set at 3.2 km/h, and at 0% grade. The grade will be increased by 2% each 2 min.
Measured: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Mar 2023
- Primary completion1 Jul 2023
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric randomized controlled trial (2 groups): Group 1 (n=30): high-intensity interval training group (HIIT) Group 2 (n=30): low-to-moderate intensity training group (LowMod)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Mazzolai, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612945
- Sponsor's protocol ID
- Exercise_intensity_PAD
- Acronym
- HIIT_PAD
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Lanzi S, Pousaz A, Fresa M, Besson C, Desgraz B, Gremeaux-Bader V, Mazzolai L. Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study). BMJ Open. 2024 Apr 17;14(4):e081883. doi: 10.1136/bmjopen-2023-081883.
PubMed 38631833
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05612945
- Acronym / sponsor ID
- HIIT_PAD / Exercise_intensity_PAD
- Conditions
- Peripheral Arterial Disease
- Keywords
- Exercise, Rehabilitation, Physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric randomized controlled trial (2 groups): Group 1 (n=30): high-intensity interval training group (HIIT) Group 2 (n=30): low-to-moderate intensity training group (LowMod)
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training group (HIIT) | Experimental | Other: High-intensity interval training group (HIIT)Exercise training sessions will consist in an alternation of brief periods (≤ 60 s) of work performed at high intensity and brief period of passive rest. Patient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. This protocol will elicits moderate-to-severe claudication pain during exertion. The training intensity in the HIIT group will be set at ≥85% HRpeak recorded during the maximal cardiopulmonary exercise test. |
| Low-to-moderate intensity training group (LowMod group) | Experimental | Other: Low-to-moderate intensity training group (LowMod group)Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at ≤76% HRpeak recorded during the maximal cardiopulmonary exercise test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with symptomatic PAD (Fontaine stage IIa/b);
- ABI ≤ 0.9 or drop by 20% following exercise treadmill test 1;
- TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency);
- Signed written informed consent form.
Key exclusion criteria (8 listed)
- Age < 18;
- Unable to walk at 3.2 km/h on a treadmill (slope 0%) at least 300 m;
- Previous participate in SET programs ≤ 1 year;
- Prior leg/foot amputation;
- Contraindication to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training group (HIIT)Exercise training sessions will consist in an alternation of brief periods (≤ 60 s) of work performed at high intensity and brief period of passive rest. Patient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. The training intensity in the HIIT group will be set at ≥85% HRpeak recorded during the maximal cardiopulmonary exercise test. The training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland). | Other | High-intensity interval training group (HIIT) |
| Low-to-moderate intensity training group (LowMod group)Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at ≤76% HRpeak recorded during the maximal cardiopulmonary exercise test. The training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland). | Other | Low-to-moderate intensity training group (LowMod group) |
Primary outcome
Maximal walking distance
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Patients will perform an incremental treadmill test to determine the maximal walking distance (MWD). Initial walking speed will be set at 3.2 km/h, and at 0% grade. The grade will be increased by 2% each 2 min.
12 secondary outcomes
Functional performance - 6-minute walk test
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - ascending and descending stair performance test
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - short physical performance battery test
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - preferred walking speed and gait analysis assessment
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - unipedal stance test
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Functional performance - 30- and 60-s repeated sit-to-stand chair test
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Cardiorespiratory fitness (VO2peak)
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Muscle oxygenation during treadmill test
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Hemodynamic parameters
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Self-perceived quality of life and walking (dis)abilities
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Total amount of physical activity
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Pain-free walking distance
Time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 38631833Lanzi S, Pousaz A, Fresa M, Besson C, Desgraz B, Gremeaux-Bader V, Mazzolai L. Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study). BMJ Open. 2024 Apr 17;14(4):e081883. doi: 10.1136/bmjopen-2023-081883.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training group (HIIT) and Low-to-moderate intensity training group (LowMod group) in people with Peripheral Arterial Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal walking distance (time frame: This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.