University of Trás-os-Montes & Alto Douro

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.

1. Summary The STOP-CSAM Study is a two-armed randomized controlled trial of a non-pharmacological Therapy Chat Service for prevention of Child Sexual Abuse (CSA) and Child Sexual Abuse Materials (CSAM) in self-referred and self motivated patients with high frequent CSAM use and non-detected by the legal authorities.
2. Trial design This study is a prospective multicentred, stratified, parallel-group superiority study conducted in Germany, Czechia and Spain.
3. Background There has been a significant increase in child sexual abuse material (CSAM) on the internet in recent years. The use of CSAM is problematic especially because it creates a demand for and maintains contact child sexual abuse. Unfortunately, despite the significant increase in the number of CSAM users, limited resources are available for investigation and prosecution. Consequently, many users remain in the community, with neither intervention from the criminal justice system, nor the health system. The proposed study will examine whether a therapy chat service (TCS) intervention reduces the demand for, circulation and spread of CSAM in undetected offenders, as compared to a control group.
4. Methods The sample consists of individuals aged 18 years or older (expected N = 630), who have used CSAM in the prior two weeks and are seeking help voluntarily. Participants will be randomized to (1) a Therapy Chat Service (TCS) intervention or (2) a four-week waitlist (control group) followed by a TCS intervention. The TCS intervention group will receive four to six one-hour online therapy chat sessions over the period of four weeks, while the control group will remain on a waitlist for these four weeks before receiving the same TCS intervention. Assessments will be conducted at baseline (pre-intervention) and at 4-, 8-, 12- and 16-weeks post-intervention. The main objective of the study is to compare the effectiveness of TCS in the prevention of CSAM use within a sample of self-referred participants. The primary outcome is the significant decrease of CSAM consumption, which will be assessed by comparing self-reported severity and time spent using CSAM in the two weeks before the intervention and at four weeks following the intervention. Potential progress measures include time spent, severity and frequency of CSAM consumed. Psychological wellbeing and total sexual outlet will be also measured as secondary outcomes, other participant variables such as risk factors for CSAM consumption or sexual interests and therapeutic variables such as number of patient-therapist interactions, modules covered per session, common factors of psychotherapy, adverse effects of intervention and dropout rate will be also measured. Outcomes between groups will be compared following standard principles for RCTs.
5. Results The study will open for recruitment in October 2023, and data collection is expected to be completed by November 2024. The results for the primary outcomes are planned to be analysed by December 2024 and submitted for publication by the end of the project in March 2025.
6. Discussion The study will test whether the TCS intervention has a positive effect, not only in terms of reducing self-seeking potential sexual offenders' problematic sexual behaviours, but also on measures such as psychological wellbeing in CSAM users. Possible adverse effects of TCS intervention will also be assessed.
Recently, a similar trial called PRIOTAB-CBT, compared pre- and post-treatment outcome measures between a treatment group to a control group (Lätth et al., 2022). Results showed a significantly larger reduction in time spent using CSAM in the treatment group, in comparison to the control group. PRIOTAB-CBTh was a single-centre, single-blinded, psychological placebo-controlled RCT of an online cognitive behavioural psychotherapy. If the STOP-CSAM trial demonstrates that a TCS intervention reduces CSAM use, it could be an effective prevention strategy for sexual violence against children.
8. Funding European Commission - Internal Security Fund (ISF-2021).

Cardiovascular disease represents a considerable economic burden to society and effective preventive measures are necessary. Patients with peripheral arterial disease (PAD) have a severe impairment of functional ability, namely in walking distance due to muscle ischemia defined as intermittent claudication (IC). The discomfort related to IC contributes to a sedentary lifestyle, decreasing physical fitness level, aggravating cardiovascular risk factors leading to disease deterioration. Exercise programs are an effective, low-cost, low-risk option compared with more invasive therapies for IC. Home-based exercise therapy (HBET) is structured, unsupervised, self-directed programs that take place in the personal setting of the patient rather than in a clinical setting. HBET program implementation is feasible and eliminates barriers such as transportation issues, proximity to clinics, and conflicts with occupational responsibilities. Even though these programs have shown to be effective at improving walking performance and distance, their results fall below those seen in Supervised Exercise Therapy (SET) programs. Thus, innovative home-based walking programs need to be developed in order to improve results and make exercise therapy available to a larger percentage of the population. The use of Information and communication technology (ICT) tools for self-monitoring is considered key to change long-term behavior. The WalkingPAD project aims to develop health technology assessment methods and evaluate personal health intervention strategies. Investigators intend to demonstrate the technical feasibility and economic viability of a personalized medicine application in real-life healthcare settings. This project intends to find evidence for three major questions: Does an M-health monitored home-based exercise program supported by a virtual assistant empowers commitment to exercise plan and allows remote control of plan accomplishment? Is it superior to an M-health monitored home-based exercise program supported by a behavioral motivational intervention, in increasing maximum walking distance? Is it superior to a self-monitoring exercise, with a specific self-designed walking plan in the residence area, in increasing maximum walking distance?