Clinical trial NCT06410521: Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Official title: Personalisation of Non-surgical Treatment in Peripheral Arterial Disease Using a Multicomponent Exercise Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Keywords: Peripheral arterial disease
Supervised multicomponent exercise programme
Lead sponsor: University of Trás-os-Montes and Alto Douro
Sponsor class: OTHER
Collaborators: name: Research Center in Sports Sciences, Health Sciences and Human Development
name: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
First posted: 2024-05-13
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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 0.95 (1-ß) showed that 44 patients would be needed to achieve statistical significance.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain-free walking distance
timeFrame: Baseline and 12 weeks
measure: Maximum walking distance
timeFrame: Baseline and 12 weeks
measure: Percentage of muscle deoxygenation
timeFrame: Baseline and 12 weeks
measure: Muscle reoxygenation time
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Pain-free walking distance
timeFrame: Baseline and 12 weeks
measure: Maximum walking distance
timeFrame: Baseline and 12 weeks
measure: Percentage of muscle deoxygenation
timeFrame: Baseline and 12 weeks
measure: Muscle reoxygenation time
timeFrame: Baseline and 12 weeks
measure: Lower limb muscle strength assessment
timeFrame: Baseline and 12 weeks
measure: Lower limb muscle power assessment
timeFrame: Baseline and 12 weeks
measure: Resting systolic blood pressure
timeFrame: Baseline and 12 weeks
measure: Resting diastolic blood pressure
timeFrame: Baseline and 12 weeks
measure: Life quality
timeFrame: Baseline and 12 weeks
measure: Daily walking ability
timeFrame: Baseline and 12 weeks
measure: Fasting blood glucose
timeFrame: Baseline and 12 weeks
measure: Sedentary behaviour
timeFrame: Baseline and 12 weeks
measure: Moderate-to-vigorous physical activity
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Ankle-brachial index
timeFrame: Baseline and 12 weeks
measure: Body composition
timeFrame: Baseline and 12 weeks
measure: Cross-sectional area of the gastrocnemius medialis muscle
timeFrame: Baseline and 12 weeks
Locations:
city: Vila Real
country: Portugal
facility: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
city: Vila Real
country: Portugal
facility: Research Centre in Sports Sciences, Health Sciences and Human Development
city: Vila Real
country: Portugal
facility: University of Trás-os-Montes and Alto Douro
Study officials:
affiliation: University of Trás-os-Montes and Alto Douro, Vila Real, Portugal
name: Catarina Abrantes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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