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.
BACKGROUND: Patients with glioma often suffer from cognitive deficits. Physical exercise has been effective in ameliorating cognitive deficits in older adults and neurological patients. This pilot randomized controlled trial (RCT) explored the possible impact of an exercise intervention, designed to improve cognitive functioning in glioma patients, regarding cognitive test performance and patient-reported outcomes (PROs).METHODS: Thirty-four clinically stable patients with World Health Organization grades II/III glioma were randomized to a home-based remotely coached exercise group or an active control group. Patients exercised 3 times per week for 20-45 minutes, with moderate to vigorous intensity, during 6 months. At baseline and immediate follow-up, cognitive performance and PROs were assessed with neuropsychological tests and questionnaires, respectively. Linear regression analyses were used to estimate effect sizes of potential between-group differences in cognitive performance and PROs at 6 months.RESULTS: The exercise group (n = 21) had small- to medium-sized better follow-up scores than the control group (n = 11) on several measures of attention and information processing speed, verbal memory, and executive function, whereas the control group showed a slightly better score on a measure of sustained selective attention. The exercise group also demonstrated small- to medium-sized better outcomes on measures of self-reported cognitive symptoms, fatigue, sleep, mood, and mental health-related quality of life.CONCLUSIONS: This small exploratory RCT in glioma patients provides a proof of concept with respect to improvement of cognitive functioning and PROs after aerobic exercise, and warrants larger exercise trials in brain tumor patients.
Abstract Background: Patients with glioma often suffer from cognitive deficits. Physical exercise has been effective in ameliorating cognitive deficits in older adults and neurological patients. This pilot randomized controlled trial (RCT) explored the possible impact of an exercise intervention, designed to improve cognitive functioning in glioma patients, regarding cognitive test performance and patient-reported outcomes (PROs). Methods: Thirty-four clinically stable patients with World Health Organization grades II/III glioma were randomized to a home-based remotely coached exercise group or an active control group. Patients exercised 3 times per week for 20-45 minutes, with moderate to vigorous intensity, during 6 months. At baseline and immediate follow-up, cognitive performance and PROs were assessed with neuropsychological tests and questionnaires, respectively. Linear regression analyses were used to estimate effect sizes of potential between-group differences in cognitive performance and PROs at 6 months. Results: The exercise group (n = 21) had small- to medium-sized better follow-up scores than the control group (n = 11) on several measures of attention and information processing speed, verbal memory, and executive function, whereas the control group showed a slightly better score on a measure of sustained selective attention. The exercise group also demonstrated small- to medium-sized better outcomes on measures of self-reported cognitive symptoms, fatigue, sleep, mood, and mental health-related quality of life. Conclusions: This small exploratory RCT in glioma patients provides a proof of concept with respect to improvement of cognitive functioning and PROs after aerobic exercise, and warrants larger exercise trials in brain tumor patients.
Aanleiding Onderzoek wijst uit dat de leesvaardigheid van zowel vmbo- als hbo-studenten te wensen over laat; studerend lezen gaat ze niet goed af. Zowel hbo- als vmbo-studenten blijken vaak onvoldoende in staat om op een bevredigende manier kennis te verwerven uit studieteksten. Samenvattend is de vraag vanuit de onderwijspraktijk: 1) Op welke wijze kunnen vmbo-leerlingen en hbo-studenten binnenschools leren om informatie uit teksten te gebruiken voor (studeertaken gericht op) kennisverwerving? 2) In hoeverre kan men bij het uitvoeren van lees-studeertaken in groepjes gebruikmaken van ICT? Doelstelling Doel van het project is de ontwikkeling van een nieuwe leeromgeving voor studerend lezen in het vmbo en hbo, en het bepalen van de effectiviteit daarvan. Het onderzoek bestaat uit 2 delen. 1) Ontwikkelonderzoek. Het onderzoeksteam optimaliseert de leeromgeving in samenwerking met lerarenopleiders en vmbo-leerkrachten en de ICT-ondersteuning wordt afgestemd op de praktijk van het zaakvakonderwijs. 2) Effectonderzoek. Er worden twee 'randomized controlled trials' uitgevoerd (een in het vmbo en een in het hbo) om te toetsen welke effecten de nieuwe leeromgeving heeft op de vaardigheid 'studerend lezen' van leerlingen en studenten. Voorafgaand aan de experimenten maken de leerlingen/studenten voortoetsen om hun woordenschat en studerend lezen in kaart te brengen. De resultaten worden ingezet als co-variaten. Beoogde resultaten Het project resulteert in: 1) meer aandacht voor ondersteuning bij het lezen van teksten in vakonderwijs; 2) de ontwikkeling van een nieuwe leeromgeving voor studerend; 3) vergroting van de leesvaardigheden van vmbo-leerlingen/hbo-studenten. Het consortium zal de gegenereerde kennis over didactiek voor studerend lezen en de rol van de ICT-ondersteunde leeromgeving daarin verspreiden via wetenschappelijke artikelen en een proefschrift, presentaties op onderwijsconferenties en publicaties in landelijke vaktijdschriften voor het vmbo en hbo. De ontwikkelde didactiek wordt door Hogeschool Rotterdam geïntegreerd in het curriculum van de lerarenopleiding en wordt verspreid binnen de hogeschool, de consortiumscholen en de scholen van het Rotterdamse schoolbestuur BOOR. Ook Stichting Lezen, een intermediair tussen wetenschap en beroepspraktijk, gaat kennis over de didactiek verspreiden. Uitgeverij ThiemeMeulenhoff helpt de didactiek en leeromgeving beschikbaar te maken voor het onderwijsveld.
