Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410521
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-07
Brief Title:
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Sponsor:
University of Trás-os-Montes and Alto Douro
Organization:
University of Trás-os-Montes and Alto Douro
Study Overview
Official Title:
Personalisation of Non-surgical Treatment in Peripheral Arterial Disease Using a Multicomponent Exercise Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 groupingdifferentiating 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 vi mid-term evaluation of the experimental group and the control group M1 - 12 weeks after viii follow-up of both groups with a home-based exercise training and ix final evaluation of both groups M2 - 24 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 three study arms i intervention arm - 12 weeks of supervised exercise cardiovascular and resistance training three times a week ii comparator arm - a usual care group that will be instructed according to standard lifestyle modification but without specific recommendations about the exercise programme and iii intervention arm - 12 weeks of home-based exercise cardiovascular training at least three times a week
Power and sample size calculations Power analysis performed in GPower software using ANOVA repeated measures within-between factors version 3197 Institut für Experimentelle Psychologie Düsseldorf Germany for an effect size of 025 an α of 005 and a power of 095 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 0181 JASP Team 2023 and the figures produced in GraphPad Prism software version 801 GraphPad Software San Diego California
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 vi mid-term evaluation of the experimental group and the control group M1 - 12 weeks after viii follow-up of both groups with a home-based exercise training and ix final evaluation of both groups M2 - 24 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 three study arms i intervention arm - 12 weeks of supervised exercise cardiovascular and resistance training three times a week ii comparator arm - a usual care group that will be instructed according to standard lifestyle modification but without specific recommendations about the exercise programme and iii intervention arm - 12 weeks of home-based exercise cardiovascular training at least three times a week
Power and sample size calculations Power analysis performed in GPower software using ANOVA repeated measures within-between factors version 3197 Institut für Experimentelle Psychologie Düsseldorf Germany for an effect size of 025 an α of 005 and a power of 095 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 0181 JASP Team 2023 and the figures produced in GraphPad Prism software version 801 GraphPad Software San Diego California
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None