OBJECTIVE: In this pilot study, we investigated the feasibility of a home-based, remotely guided exercise intervention for patients with gliomas.DESIGN: Pilot randomized controlled trial (RCT) with randomization (2:1) to exercise or control group.SUBJECTS: Patients with stable grade II and III gliomas.INTERVENTION: The six-month intervention included three home-based exercise sessions per week at 60%-85% of maximum heart rate. Participants wore heart rate monitors connected to an online platform to record activities that were monitored weekly by the physiotherapist.MAIN MEASURES: Accrual, attrition, adherence, safety, satisfaction, patient-reported physical activity, VO2 peak (by maximal cardiopulmonary exercise testing) and body mass index (BMI) at baseline and at six-month follow-up.RESULTS: In all, 34 of 136 eligible patients (25%) were randomized to exercise training ( N = 23) or the control group ( N = 11), of whom 19 and 9, respectively, underwent follow-up. Mean adherence to prescribed sessions was 79%. Patients' experiences were positive. There were no adverse events. Compared to the control group, the exercise group showed larger improvements in absolute VO2 peak (+158.9 mL/min; 95% CI: -44.8 to 362.5) and BMI (-0.3 kg/m²; 95% CI: -0.9 to 0.2). The median increase in physical activity was 1489 metabolic equivalent of task (MET) minutes higher in the exercise group. The most reported reasons for non-participation were lack of motivation or time.CONCLUSION: This innovative and intensive home-based exercise intervention was feasible in a small subset of patients with stable gliomas who were interested in exercising. The observed effects suggest that the programme may improve cardiorespiratory fitness. These results support the need for large-scale trials of exercise interventions in brain tumour patients.
Background: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
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OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy.METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed.CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.
Een goede voorbereiding is het halve werk, ook voor patiënten op de wachtlijst voor een chirurgische ingreep. We onderzoeken hoe de e-health-applicatie 'Beter Voorbereid' mensen helpt om sterker aan de start van een operatie te staan en zo sneller te herstellen.
Een goede voorbereiding is het halve werk, ook voor patiënten op de wachtlijst voor een chirurgische ingreep. We onderzoeken hoe de e-health-applicatie 'Beter Voorbereid' mensen helpt om sterker aan de start van een operatie te staan en zo sneller te herstellen.Doel De e-health-applicatie Beter Voorbereid helpt patiënten om zich voor te bereiden op hun operatie. Ons onderzoek richt zich op de effectiviteit, verbetering en implementatie van de app met vier werkpakketten: Het optimaliseren van de app op basis van ervaringen van patiënten en zorgverleners. Het vormen van een netwerk van eerste- en tweedelijns zorgverleners die zorg voorafgaande aan een operatie bieden. Het onderzoeken van de effectiviteit van de app. Het opstellen van een implementatieplan, inclusief businessmodellen, van de app Beter Voorbereid. Resultaten Dit onderzoek loopt momenteel. Na afronding vind je hier een samenvatting van de resultaten. Lees meer over dit project op beter-voorbereid.nl. Looptijd 01 november 2018 - 01 januari 2023 Aanpak Binnen het Amsterdam UMC, locatie VUmc en het UMC Utrecht is een pilot gehouden naar de studieprocedures en bruikbaarheid van de applicatie. Naar aanleiding van deze resultaten worden verbeteringen doorgevoerd in de procedures van het onderzoek en de inhoud van de applicatie. Vervolgens zal in vier ziekenhuizen een groot Randomized Controlled Trial (RCT) starten naar de effectiviteit van de applicatie. Naast het Amsterdam UMC en UMC Utrecht zal dit ook plaatsvinden bij het Dijklander ziekenhuis in Hoorn. In deze periode zal ook het onderzoek naar de bredere implementatie van de app 'Beter Voorbereid' worden uitgevoerd.
Effectiveness of Supported Education for students with mental health problems, an experimental study.The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow postsecondary education, which is a major channel in ourso ciety to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on educational and mental health outcomes of students with mental health problems at a university of applied sciences and a community college. To that end, a mixed methods design will be used. This design combines quantitative research (Randomized Controlled Trial) with qualitative research (focus groups, monitoring, interviews). 100 students recruited from the two educational institutes will be randomly allocated to either the intervention or control group.
