Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Trás-os-Montes and Alto Douro
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralPatients 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 care
BehavioralPatients 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Supervised multicomponent exerciseExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksOther outcomes
1
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 weeks2
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 weeks3
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 weeksSponsors and contacts
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University of Trás-os-Montes and Alto Douro
Lead sponsor
Research Center in Sports Sciences, Health Sciences and Human Development
Collaborator
Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
Collaborator
Source ClinicalTrials.gov