An interventional study of Exercise and Usual care in Peripheral Arterial Disease and Intermittent Claudication, sponsored by University of Trás-os-Montes and Alto Douro. Recruiting at 3 sites in Portugal. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Trás-os-Montes and Alto Douro · Not applicable, Interventional, and Treatment
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.
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).
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 40 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →University of Trás-os-Montes and Alto Douro is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Compared within Intermittent Claudication, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Exercise
Active comparator arm will be advised to lifestyle modification and to perform regular walking for a period of 12 weeks.
Behavioral: Usual care
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.
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and 12 weeks
Pain-free walking distance
Distance until onset of claudication (in meters) will be measured in patients undergoing the 6-minute walk test.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Muscle reoxygenation time
The muscle reoxygenation time (in seconds) will be measured in patients undergoing the 6-minute walk test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Sedentary behaviour
The sedentary behaviour (in min/day) will be measured in patients over seven consecutive days.
Time frame: 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.
Time frame: Baseline and 12 weeks
Ankle-brachial index
The ankle-brachial index (in a.u.) will be measured in patients after a 10-minutes rest in a lying position.
Time frame: Baseline and 12 weeks
Body composition
The body composition (the unit will depend on the derived-parameters evaluated) will be measured in patients in the orthostatic position according to guidelines.
Time frame: Baseline and 12 weeks
Cross-sectional area of the gastrocnemius medialis muscle
The cross-sectional area of the gastrocnemius medialis muscle of both lower limbs will be determined through an echographic evaluation.
Time frame: Baseline and 12 weeks
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Trás-os-Montes and Alto Douro