Peripheral Arterial DiseaseNCT06410521
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
A study testing Exercise in people with Peripheral Arterial Disease and Intermittent Claudication, run by University of Trás-os-Montes and Alto Douro at 3 sites in Portugal.
Trial summary
Peripheral arterial disease (PAD) is characterised as an atherosclerotic disease, most common in the lower limbs (aortoiliac, femoropopliteal, and infrapopliteal arterial segments), which causes a decrease in blood flow to the areas adjacent to and posterior to the affected area. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesPortugal
- Study dates
- 20 Jun 2025to Dec 2027
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with clinically stable PAD;
- An ankle-brachial index (ABI) between 0.41-0.90 at rest in one or both lower limbs;
- Mild to moderate claudication, corresponding to Fontaine Stage IIa and IIb;
- A history of ambulatory leg pain;
- Ambulatory leg pain confirmed by treadmill test;
- Able to provide written consent.
Who cannot join
- Noncompressible, calcified, tibial arteries (resting ABI ≥ 1.4);
- Use of medication that could influence claudication (e.g. Cilostazol or Pentoxifylline) 3 months prior to investigation;
- Previous intervention (e.g. balloon angioplasty, stenting, bypass, exercise programme);
- Inability to walk on a treadmill at a speed of 3.2 km/h (2 mph);
- Participation in the past 3 months in a clinical trial or exercise program;
- Asymptomatic PAD determined from the medical history;
- Exercise limited by factors other diseases or conditions than intermittent claudication;
- Angina pectoris, congestive heart failure, chronic obstructive pulmonary disease, severe arthritis, or limb amputation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal3 sites, 3 recruiting
- Recruiting
Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
Vila Real, 5000-508
Irene Pinto
Jacinta Campos, M.Sc.
- Recruiting
Research Centre in Sports Sciences, Health Sciences and Human Development
Vila Real, 5000-801
Catarina Abrantes, Ph.D., 934286001, abrantes@utad.pt
Catarina Abrantes, Ph.D.
- Recruiting
University of Trás-os-Montes and Alto Douro
Vila Real, 5000-801
Catarina Isabel Neto Gavião Abrantes, Ph.D., 934286001, abrantes@utad.pt
Catarina Abrantes, Ph.D.
About this study
Official title: Personalisation of Non-surgical Treatment in Peripheral Arterial Disease Using a Multicomponent Exercise Approach
Peripheral arterial disease (PAD) is characterised as an atherosclerotic disease, most common in the lower limbs (aortoiliac, femoropopliteal, and infrapopliteal arterial segments), which causes a decrease in blood flow to the areas adjacent to and posterior to the affected area. Intermittent claudication (IC) is the most common symptom in this disease that appears with exertion and relieves with rest, causing fatigue, cramps, discomfort, or pain in the lower limbs due to limited blood flow to the affected muscles. Supervised physical exercise has emerged as the first line of intervention in improving the symptoms of intermittent claudication and disease progression, and in the last decade there has been an exponential increase in the use of wearable technologies to monitor dose-response. However, the approach used is still simplistic because it is not personalised. In other words, patients with similar diagnoses and symptoms get the same treatment, without personalising the stimulus according to their exercise responses and level of adaptation. With this in mind, this study aims to monitoring the real-time response of a multicomponent exercise programme (cardiovascular and resistance training) to personalise the dose-response, and use artificial intelligence models to gather and analyse vast amounts of data towards grouping/differentiating based on individual responses. The main hypothesis is that a supervised multicomponent exercise programme will improve the functional capacity of patients with PAD in a cluster personalised approach.
Read the detailed description
Framework: Continuous monitoring of training allows for a better understanding and adjustment of the proposed objectives, based on the physiological responses provided. With the use of wearables increasing significantly and emerging as the main trend since 2016, near-infrared spectroscopy (NIRS) has been gaining emphasis as method for assessing muscle oxygen saturation (SmO2) and is an important tool in exercise monitoring. In the field of PAD, the use of NIRS is also fundamental as it allows the oxygen available in the muscle to be visualised in real time. NIRS technology makes it possible to observe the response to exercise in detail, in terms of deoxygenation and reoxygenation, which are essential analysis processes since PAD is characterised by oxygen insufficiency and the responses are highly individualised. In conjunction, the use of high-precision accelerometry (1600 Hz) helps to identify all the movements made by analysing the responses in the different axes. Based on the considerable gap in the literature regarding the effect of continuous monitoring and personalisation of the dose-response in this population, this study aims to assess the effect of a multicomponent cardiovascular and resistance training programme, personalised, and continuously monitored through heart rate (HR) and SmO2.
The experimental design comprises the following phases: i) programme design; ii) sample recruitment; iii) initial evaluation of the experimental group (Supervised exercise training) and the control group (Usual care) (M0 - 0 week); iv) personalisation of the exercise load; v) programme implementation; and vi) final evaluation of both groups (M1 - 12 weeks after).
Sample: Patients with PAD will be recruited at the Local Health Unit of Trás-os-Montes and Alto Douro, by the Angiology and Vascular Surgery Service. Participation in the study will be voluntary and written informed consent will be obtained from each patient. After the baseline assessments patient will be randomised to 1 of 2 groups, using a random number program with blocking to assure that the group sizes do not differ by >2.
Intervention: There will be two study arms: i) intervention arm - 12 weeks of supervised exercise (cardiovascular and resistance training) three times a week; and ii) comparator arm - a usual care group that will be instructed according to standard lifestyle modification but without specific recommendations about the exercise programme.
Power and sample size calculations: Power analysis performed in G*Power software (using ANOVA repeated measures within-between factors), version 3.1.9.7 (Institut für Experimentelle Psychologie, Düsseldorf, Germany) for an effect size of 0.25, an α of 0.05, and a power of 0.80 (1-ß) showed that 34 patients would be needed to achieve statistical significance. Considering the potential loss to follow-up, an attrition rate of 10% will be added to the calculated n, totalling 38 patients to be recruited.
Statistical analysis: Statistical analyses will be carried out using JASP software, version 0.18.1 (JASP Team, 2023) and the figures produced in GraphPad Prism software, version 8.0.1 (GraphPad Software, San Diego, California).
- Being tested
- Exercise, Usual care
- Keywords
- Peripheral arterial disease, Supervised multicomponent exercise programme
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Patients randomised to the intervention arm will undergo non-consecutive training sessions three times a week for a period of 12 weeks. The training session is divided into an aerobic and a resistance training component, with a 5-min warm-up (stretching exercises) and a 5-min cool-down (stretching and relaxing exercises). The cardiovascular component will comprise a progressive exercise duration from 30 to 40 minutes, an exercise intensity promoting moderate to severe claudication pain between 8-12 minutes, with rest time until the pain disappears, and a personalised load progression manipulated based on the claudication pain level, reaching a total of 60 minutes of walking per session. The resistance training component will comprise dynamic muscle contraction exercises (Leg extension, unilateral hip extension, and standing calf raise), with a load progression from 50% of 1-estimated one repetition maximum (e-RM) to 80% of 1-eRM.
Usual careBehavioural
Patients randomised to the active comparator arm will be advised about the importance of lifestyle modification (including general advice to increase walking but without specific recommendations about the exercise program) for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Supervised multicomponent exercise | Experimental | Experimental arm will perform the supervised exercise programme three times a week, with each session taking approximately 60-80 minutes for a period of 12 weeks. Receives: Behavioral: Exercise |
| Usual care | Active comparator | Active comparator arm will be advised to lifestyle modification and to perform regular walking for a period of 12 weeks. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-free walking distance
Distance until onset of claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
Measured: Baseline and 12 weeks
Maximum walking distance
Walking distance until maximum claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
Measured: Baseline and 12 weeks
Percentage of muscle deoxygenation
The percentage of muscle deoxygenation (in %) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
Measured: Baseline and 12 weeks
Muscle reoxygenation time
The muscle reoxygenation time (in seconds) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
Measured: Baseline and 12 weeks
Secondary outcomes (13)
Pain-free walking distance
Distance until onset of claudication (in meters) will be measured in patients undergoing the 6-minute walk test.
Measured: Baseline and 12 weeks
Maximum walking distance
Walking distance until maximum claudication (in meters) will be measured in patients undergoing the 6-minute walk test.
Measured: Baseline and 12 weeks
Percentage of muscle deoxygenation
The percentage of muscle deoxygenation (in %) will be measured in patients undergoing the 6-minute walk test.
Measured: Baseline and 12 weeks
Muscle reoxygenation time
The muscle reoxygenation time (in seconds) will be measured in patients undergoing the 6-minute walk test.
Measured: Baseline and 12 weeks
Lower limb muscle strength assessment
The peak force (in kg) will be measured in patients using the hand-held dynamometry test.
Measured: Baseline and 12 weeks
Lower limb muscle power assessment
The rate of force development (in kg/s) will be measured in patients using the hand-held dynamometry test.
Measured: Baseline and 12 weeks
Resting systolic blood pressure
The resting systolic blood pressure (in mmHg) will be measured in patients after a 10-minute rest in a lying position.
Measured: Baseline and 12 weeks
Resting diastolic blood pressure
The resting diastolic blood pressure (in mmHg) will be measured in patients after a 10-minute rest in a lying position.
Measured: Baseline and 12 weeks
Life quality
The quality of life will be measured in patients using the 36-Item Short Form Survey that contains the domains of mental component and physical component.
Measured: Baseline and 12 weeks
Daily walking ability
The daily walking will be measured in patients using the Walking Impairment Questionnaire that contains the domains of walking distance, walking speed and ability to climb stairs.
Measured: Baseline and 12 weeks
Fasting blood glucose
The fasting blood glucose (in mg/dL) will be measured in patients using the fasting blood glucose test.
Measured: Baseline and 12 weeks
Sedentary behaviour
The sedentary behaviour (in min/day) will be measured in patients over seven consecutive days.
Measured: Baseline and 12 weeks
Moderate-to-vigorous physical activity
Moderate-to-vigorous physical activity (in min/day) will be measured in patients over seven consecutive days.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start20 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- The study design will comprise two evaluation moments: initial evaluation (M0 - 0 week) and final evaluation (M1 - 12 weeks after). After M0 patients will be randomised into the intervention arm (experimental group) and comparator arm (usual care group). The intervention arm will perform supervised exercise (cardiovascular and resistance training) three times a week for 12 weeks and the comparator arm will receive information regarding standard lifestyle modification but without specific recommendations about the exercise programme.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development, Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
- Responsible party
- Sponsor
- Investigators
- Catarina Abrantes, Ph.D., Principal investigator, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410521
- Sponsor's protocol ID
- PASSUS 2.0
- Status last verified
- Jun 2025
- First submitted
- 7 May 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
PubMed 28886620Baltrunas T, Mosenko V, Mackevicius A, Dambrauskas V, Asakiene I, Rucinskas K, Narmontas P. The use of near-infrared spectroscopy in the diagnosis of peripheral artery disease: A systematic review. Vascular. 2022 Aug;30(4):715-727. doi: 10.1177/17085381211025174. Epub 2021 Jun 10.
PubMed 34112030Cornelis N, Chatzinikolaou P, Buys R, Fourneau I, Claes J, Cornelissen V. The Use of Near Infrared Spectroscopy to Evaluate the Effect of Exercise on Peripheral Muscle Oxygenation in Patients with Lower Extremity Artery Disease: A Systematic Review. Eur J Vasc Endovasc Surg. 2021 May;61(5):837-847. doi: 10.1016/j.ejvs.2021.02.008. Epub 2021 Mar 30.
PubMed 33810977Nordanstig J, Behrendt CA, Bradbury AW, de Borst GJ, Fowkes F, Golledge J, Gottsater A, Hinchliffe RJ, Nikol S, Norgren L. Peripheral arterial disease (PAD) - A challenging manifestation of atherosclerosis. Prev Med. 2023 Jun;171:107489. doi: 10.1016/j.ypmed.2023.107489. Epub 2023 Apr 7.
PubMed 37031910Perrey S, Ferrari M. Muscle Oximetry in Sports Science: A Systematic Review. Sports Med. 2018 Mar;48(3):597-616. doi: 10.1007/s40279-017-0820-1.
PubMed 29177977
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalisation of Non-surgical Treatment in Peripheral Arterial Disease Using a Multicomponent Exercise Approach
- ClinicalTrials.gov ID
- NCT06410521
- Acronym / sponsor ID
- PASSUS 2.0
- Keywords
- Peripheral arterial disease, Supervised multicomponent exercise programme
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development, Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 May 2024 (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.
Peripheral arterial disease (PAD) is characterised as an atherosclerotic disease, most common in the lower limbs (aortoiliac, femoropopliteal, and infrapopliteal arterial segments), which causes a decrease in blood flow to the areas adjacent to and posterior to the affected area. Intermittent claudication (IC) is the most common symptom in this disease that appears with exertion and relieves with rest, causing fatigue, cramps, discomfort, or pain in the lower limbs due to limited blood flow to the affected muscles. Supervised physical exercise has emerged as the first line of intervention in improving the symptoms of intermittent claudication and disease progression, and in the last decade there has been an exponential increase in the use of wearable technologies to monitor dose-response. However, the approach used is still simplistic because it is not personalised. In other words, patients with similar diagnoses and symptoms get the same treatment, without personalising the stimulus according to their exercise responses and level of adaptation. With this in mind, this study aims to monitoring the real-time response of a multicomponent exercise programme (cardiovascular and resistance training) to personalise the dose-response, and use artificial intelligence models to gather and analyse vast amounts of data towards grouping/differentiating based on individual responses. The main hypothesis is that a supervised multicomponent exercise programme will improve the functional capacity of patients with PAD in a cluster personalised approach.
Detailed description
Framework: Continuous monitoring of training allows for a better understanding and adjustment of the proposed objectives, based on the physiological responses provided. With the use of wearables increasing significantly and emerging as the main trend since 2016, near-infrared spectroscopy (NIRS) has been gaining emphasis as method for assessing muscle oxygen saturation (SmO2) and is an important tool in exercise monitoring. In the field of PAD, the use of NIRS is also fundamental as it allows the oxygen available in the muscle to be visualised in real time. NIRS technology makes it possible to observe the response to exercise in detail, in terms of deoxygenation and reoxygenation, which are essential analysis processes since PAD is characterised by oxygen insufficiency and the responses are highly individualised. In conjunction, the use of high-precision accelerometry (1600 Hz) helps to identify all the movements made by analysing the responses in the different axes. Based on the considerable gap in the literature regarding the effect of continuous monitoring and personalisation of the dose-response in this population, this study aims to assess the effect of a multicomponent cardiovascular and resistance training programme, personalised, and continuously monitored through heart rate (HR) and SmO2.
The experimental design comprises the following phases: i) programme design; ii) sample recruitment; iii) initial evaluation of the experimental group (Supervised exercise training) and the control group (Usual care) (M0 - 0 week); iv) personalisation of the exercise load; v) programme implementation; and vi) final evaluation of both groups (M1 - 12 weeks after).
Sample: Patients with PAD will be recruited at the Local Health Unit of Trás-os-Montes and Alto Douro, by the Angiology and Vascular Surgery Service. Participation in the study will be voluntary and written informed consent will be obtained from each patient. After the baseline assessments patient will be randomised to 1 of 2 groups, using a random number program with blocking to assure that the group sizes do not differ by >2.
Intervention: There will be two study arms: i) intervention arm - 12 weeks of supervised exercise (cardiovascular and resistance training) three times a week; and ii) comparator arm - a usual care group that will be instructed according to standard lifestyle modification but without specific recommendations about the exercise programme.
Power and sample size calculations: Power analysis performed in G*Power software (using ANOVA repeated measures within-between factors), version 3.1.9.7 (Institut für Experimentelle Psychologie, Düsseldorf, Germany) for an effect size of 0.25, an α of 0.05, and a power of 0.80 (1-ß) showed that 34 patients would be needed to achieve statistical significance. Considering the potential loss to follow-up, an attrition rate of 10% will be added to the calculated n, totalling 38 patients to be recruited.
Statistical analysis: Statistical analyses will be carried out using JASP software, version 0.18.1 (JASP Team, 2023) and the figures produced in GraphPad Prism software, version 8.0.1 (GraphPad Software, San Diego, California).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design will comprise two evaluation moments: initial evaluation (M0 - 0 week) and final evaluation (M1 - 12 weeks after). After M0 patients will be randomised into the intervention arm (experimental group) and comparator arm (usual care group). The intervention arm will perform supervised exercise (cardiovascular and resistance training) three times a week for 12 weeks and the comparator arm will receive information regarding standard lifestyle modification but without specific recommendations about the exercise programme.
| Arm | Type | Receives |
|---|---|---|
| Supervised multicomponent exercise | Experimental | Behavioral: ExerciseExperimental arm will perform the supervised exercise programme three times a week, with each session taking approximately 60-80 minutes for a period of 12 weeks. |
| Usual care | Active comparator | Behavioral: Usual careActive comparator arm will be advised to lifestyle modification and to perform regular walking for a period of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with clinically stable PAD;
- An ankle-brachial index (ABI) between 0.41-0.90 at rest in one or both lower limbs;
- Mild to moderate claudication, corresponding to Fontaine Stage IIa and IIb;
- A history of ambulatory leg pain;
- Ambulatory leg pain confirmed by treadmill test;
Key exclusion criteria (8 listed)
- Noncompressible, calcified, tibial arteries (resting ABI ≥ 1.4);
- Use of medication that could influence claudication (e.g. Cilostazol or Pentoxifylline) 3 months prior to investigation;
- Previous intervention (e.g. balloon angioplasty, stenting, bypass, exercise programme);
- Inability to walk on a treadmill at a speed of 3.2 km/h (2 mph);
- Participation in the past 3 months in a clinical trial or exercise program;
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 |
|---|---|---|
| ExercisePatients randomised to the intervention arm will undergo non-consecutive training sessions three times a week for a period of 12 weeks. The training session is divided into an aerobic and a resistance training component, with a 5-min warm-up (stretching exercises) and a 5-min cool-down (stretching and relaxing exercises). The cardiovascular component will comprise a progressive exercise duration from 30 to 40 minutes, an exercise intensity promoting moderate to severe claudication pain between 8-12 minutes, with rest time until the pain disappears, and a personalised load progression manipulated based on the claudication pain level, reaching a total of 60 minutes of walking per session. The resistance training component will comprise dynamic muscle contraction exercises (Leg extension, unilateral hip extension, and standing calf raise), with a load progression from 50% of 1-estimated one repetition maximum (e-RM) to 80% of 1-eRM. | Behavioural | Supervised multicomponent exercise |
| Usual carePatients randomised to the active comparator arm will be advised about the importance of lifestyle modification (including general advice to increase walking but without specific recommendations about the exercise program) for a period of 12 weeks. | Behavioural | Usual care |
Primary outcome
Pain-free walking distance
Time frame: Baseline and 12 weeks
Distance until onset of claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
Maximum walking distance
Time frame: Baseline and 12 weeks
Walking distance until maximum claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
Percentage of muscle deoxygenation
Time frame: Baseline and 12 weeks
The percentage of muscle deoxygenation (in %) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
Muscle reoxygenation time
Time frame: Baseline and 12 weeks
The muscle reoxygenation time (in seconds) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
13 secondary outcomes
Pain-free walking distance
Time frame: Baseline and 12 weeks
Maximum walking distance
Time frame: Baseline and 12 weeks
Percentage of muscle deoxygenation
Time frame: Baseline and 12 weeks
Muscle reoxygenation time
Time frame: Baseline and 12 weeks
Lower limb muscle strength assessment
Time frame: Baseline and 12 weeks
Lower limb muscle power assessment
Time frame: Baseline and 12 weeks
Resting systolic blood pressure
Time frame: Baseline and 12 weeks
Resting diastolic blood pressure
Time frame: Baseline and 12 weeks
Life quality
Time frame: Baseline and 12 weeks
Daily walking ability
Time frame: Baseline and 12 weeks
Fasting blood glucose
Time frame: Baseline and 12 weeks
Sedentary behaviour
Time frame: Baseline and 12 weeks
Moderate-to-vigorous physical activity
Time frame: Baseline and 12 weeks
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 27 Jun 2025.
- Background: PubMed 28886620Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
- Background: PubMed 34112030Baltrunas T, Mosenko V, Mackevicius A, Dambrauskas V, Asakiene I, Rucinskas K, Narmontas P. The use of near-infrared spectroscopy in the diagnosis of peripheral artery disease: A systematic review. Vascular. 2022 Aug;30(4):715-727. doi: 10.1177/17085381211025174. Epub 2021 Jun 10.
- Background: PubMed 33810977Cornelis N, Chatzinikolaou P, Buys R, Fourneau I, Claes J, Cornelissen V. The Use of Near Infrared Spectroscopy to Evaluate the Effect of Exercise on Peripheral Muscle Oxygenation in Patients with Lower Extremity Artery Disease: A Systematic Review. Eur J Vasc Endovasc Surg. 2021 May;61(5):837-847. doi: 10.1016/j.ejvs.2021.02.008. Epub 2021 Mar 30.
- Background: PubMed 37031910Nordanstig J, Behrendt CA, Bradbury AW, de Borst GJ, Fowkes F, Golledge J, Gottsater A, Hinchliffe RJ, Nikol S, Norgren L. Peripheral arterial disease (PAD) - A challenging manifestation of atherosclerosis. Prev Med. 2023 Jun;171:107489. doi: 10.1016/j.ypmed.2023.107489. Epub 2023 Apr 7.
- Background: PubMed 29177977Perrey S, Ferrari M. Muscle Oximetry in Sports Science: A Systematic Review. Sports Med. 2018 Mar;48(3):597-616. doi: 10.1007/s40279-017-0820-1.
- Individual participant dataSharing planned: No
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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.
Catarina Abrantes, Ph.D. principal investigator
University of Trás-os-Montes and Alto Douro, Vila Real, Portugal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Peripheral Arterial Disease and Intermittent Claudication, run by University of Trás-os-Montes and Alto Douro at 3 sites in Portugal.
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 6 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
Contact Catarina Abrantes, Ph.D. (259350000, abrantes@utad.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-free walking distance (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. 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 NCT06410521, which also lists 5 linked publications.
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 27 Jun 2025.