1,721,169 research outputs found

    Intermediate outcomes for clinical trials of multiple sclerosis rehabilitation interventions: Conceptual and practical considerations

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    Background:Rehabilitation is an essential health care service and a critical component of comprehensive multiple sclerosis (MS) care. Objective:As part of a 2-day meeting hosted by the International Advisory Committee on Clinical Trials in MS in December 2022, a panel initiated a discussion on the conceptual and practical issues related to selecting intermediate outcomes for clinical trials of MS rehabilitation interventions. Results:The overarching goal of rehabilitation - optimal functioning - was acknowledged as a complex biopsychosocial phenomenon that varies with patient priorities and environmental context. This complexity means that multiple causal pathways and potential intermediate outcomes must be carefully considered during the design of clinical trials in MS rehabilitation that aim to improve functioning. In addition, practical issues must be considered such as psychometric properties of outcome measures, measure type, and characteristics of the target population, including severity of dysfunction. Conclusion:This article uses the International Classification of Functioning, Disability and Health as a foundation for determining relevant intermediate outcomes for clinical trials of MS rehabilitation interventions.The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: The International Advisory Committee on Clinical Trials in Multiple Sclerosis and the International Conference on Innovations in Clinical Trial Design & Enhancing Inclusivity of Clinical Trial Populations were supported by the National Multiple Sclerosis Society and the European Committee for Treatment and Research in Multiple Sclerosis. There was no involvement of the sponsors in the design, collection, analysis or interpretation of data discussed at the Conference. The opinions expressed are those of the authors. Open access was made possible by the participation of Queen’s University in the Canadian Research Knowledge Network

    Day-to-day reliability, agreement and discriminative validity of measuring walking-related performance fatigability in persons with Multiple Sclerosis

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    Background: Day-to-day reliability and cut-off values to detect abnormal walking fatigability (WF) remain to be investigated in persons with multiple sclerosis (pwMS). Methods: In all, 49 pwMS (mean Expanded Disability Status Scale (EDSS) ± standard deviation (SD): 3.3 ± 1.9) and 28 matched healthy controls (HC) performed the six-minute walking test (6MWT) on two different days to determine day-to-day reliability (intraclass correlation coefficient (ICC)) and limits of agreement (LOA) for five different equations of WF. Objective: To examine day-to-day reliability, agreement and discriminative validity for measuring WF. Results and conclusion: WF expressed as the ratio between the first and sixth minute had the best day-to-day reliability (ICC’s range of 0.76–0.95 and 0.60–0.86, respectively) in both pwMS and HC, while LOA were 15% and 7%, respectively. Ecological validity and clinical importance should be further investigated.The author(s) received no financial support for the research, authorship, and/or publication of this article

    Efficacy of Progressive Power Training in Enhancing Neuromuscular and Physical Function in Older Patients with Multiple Sclerosis: Preliminary Results from the PoTOMS Trial

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    outcomes were Peak Power Output (PPO) of a graded exercise test (Watts), 10-Meter-Walk-Test (10MWT), Two-Minute-Walk-Test (2MWT), Six-Minute-Walk-Test (6MWT), Timed-Up-and-Go-Test (TUG) and Patient-Reported-Outcomes-Measurement-Information-System-Questionnaire (PROMIS) at baseline (T 0) and discharge after three weeks (T 1). Results: The study protocol is feasible (80% of participants completed 79% of planned series within planned sessions) and 88% of the data collection could be successfully achieved. Results of the interviews show high acceptability and motivation. The descriptive analysis of the secondary outcomes showed improvements of the mean values of all outcomes: Increase of 6.07% in Introduction: Fatigue is a complex, debilitating, and highly frequent symptom in people with multiple sclerosis (PWMS). The modified fatigue impact scale (MFIS) estimates fatigue and subdivides it into a physical (MFISphysical) and a cognitive component (MFIScognitive). Both aerobic training (AT) and resistance training (RT) reduce fatigue. However, the effects of the two modalities have not been directly compared. Objective: To perform a head-to-head comparison of the effectiveness of AT and RT on fatigue measured by MFIS in PWMS. Materials & Methods: A total of 150 PWMS (45±8 years, EDSS score 2.7 ± 1.6, 73 % women) were enrolled and randomized in a 2:2:1 ratio into either 12 weeks of AT (n=60, 30 sessions), RT (n=60, 30 sessions), or control ('usual care', n=30). Pre and post intervention assessments of isometric knee extensor muscle strength (MVC; isokinetic dynamometry), aerobic capacity (VO2peak; incremental exercise test), and fatigue (MFIS) were performed. Results: Aerobic capacity increased in AT vs. control by 5.6 [2.0;9.2] mL O 2 /min/kg (mean [95CI]) and in AT vs. RT by 3.6 [0.8;6.6], but not in RT vs. control (1.9 [-1.6;5.5]). Knee extensor muscle strength increased in RT vs. control by 1.03 [0.25;1.80] Nm/kg and in RT vs. AT 0.68 [0.27;1.08], but not in AT vs. control (0.35 [-0.42;1.13]). MFIS total seemed not to be reduced in neither RT vs. control-5.6 [-14.9; 3.7] points nor in AT vs. R

    Efficacy of Progressive Power Training in Enhancing Neuromuscular and Physical Function in Older Patients with Multiple Sclerosis: Preliminary Results from the PoTOMS Trial

    No full text
    outcomes were Peak Power Output (PPO) of a graded exercise test (Watts), 10-Meter-Walk-Test (10MWT), Two-Minute-Walk-Test (2MWT), Six-Minute-Walk-Test (6MWT), Timed-Up-and-Go-Test (TUG) and Patient-Reported-Outcomes-Measurement-Information-System-Questionnaire (PROMIS) at baseline (T 0) and discharge after three weeks (T 1). Results: The study protocol is feasible (80% of participants completed 79% of planned series within planned sessions) and 88% of the data collection could be successfully achieved. Results of the interviews show high acceptability and motivation. The descriptive analysis of the secondary outcomes showed improvements of the mean values of all outcomes: Increase of 6.07% in Introduction: Fatigue is a complex, debilitating, and highly frequent symptom in people with multiple sclerosis (PWMS). The modified fatigue impact scale (MFIS) estimates fatigue and subdivides it into a physical (MFISphysical) and a cognitive component (MFIScognitive). Both aerobic training (AT) and resistance training (RT) reduce fatigue. However, the effects of the two modalities have not been directly compared. Objective: To perform a head-to-head comparison of the effectiveness of AT and RT on fatigue measured by MFIS in PWMS. Materials & Methods: A total of 150 PWMS (45±8 years, EDSS score 2.7 ± 1.6, 73 % women) were enrolled and randomized in a 2:2:1 ratio into either 12 weeks of AT (n=60, 30 sessions), RT (n=60, 30 sessions), or control ('usual care', n=30). Pre and post intervention assessments of isometric knee extensor muscle strength (MVC; isokinetic dynamometry), aerobic capacity (VO2peak; incremental exercise test), and fatigue (MFIS) were performed. Results: Aerobic capacity increased in AT vs. control by 5.6 [2.0;9.2] mL O 2 /min/kg (mean [95CI]) and in AT vs. RT by 3.6 [0.8;6.6], but not in RT vs. control (1.9 [-1.6;5.5]). Knee extensor muscle strength increased in RT vs. control by 1.03 [0.25;1.80] Nm/kg and in RT vs. AT 0.68 [0.27;1.08], but not in AT vs. control (0.35 [-0.42;1.13]). MFIS total seemed not to be reduced in neither RT vs. control-5.6 [-14.9; 3.7] points nor in AT vs. R

    Accelerated Trajectories of Walking Capacity Across the Adult Life Span in Persons With Multiple Sclerosis: An Underrecognized Challenge

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    Background. In the general population, trajectories of walking capacity is accelerated and nonlinear with advanced age. Whether this is more pronounced in persons with multiple sclerosis (pwMS), along with the prevalence of dismobility (ie, slow gait speed), are currently unknown. Our objective was to investigate trajectories of walking capacity and prevalence of dismobility across the adult life span in pwMS versus healthy controls (HC). Methods. Data on maximal timed 25-foot walk test (T25FWT), 2-minute walk test (2MWT), and 6-minute walk test (6MWT) along with prevalence of dismobility were assembled from 2 RIMS multicenter studies (n = 502 pwMS; age range 21-77 years, 6 age groups: 20-29, 30-39, 40-49, 50-59, 60-69, and 70-79 years). HC data were extracted from studies containing normative reference values (n = 1070-3780 HC). Results. Age trajectories of walking capacity was nonlinear and accelerated in pwMS versus HC. While measures of walking capacity in pwMS were suppressed already early in life, the gap between pwMS and HC significantly widened across the 6 age groups (pwMS performed 64%, 70%, 57%, 59%, 51%, and 37% of HC, respectively). This coincided with high prevalences of dismobility in pwMS across the 6 age groups when using usual gait speed cut-point values <1.0 m/s (corresponding to 33%, 32%, 51%, 59%, 75%, and 100%) and <0.6 m/s (corresponding to 19%, 12%, 26%, 23%, 33%, and 43%), markedly exceeding that observed in HC. Conclusion. The present data on walking capacity provide evidence for an accelerated deterioration in pwMS with advanced age, coinciding with high prevalences of dismobility (ie, slow gait speed).The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was partially funded via an unrestricted educational grant from Novartis Pharma AG to Rehabilitation in Multiple Sclerosis, the European network for best practice and research in MS rehabilitation (eurims.org).Hvid, LG (reprint author), Aarhus Univ, Sect Sport Sci, Dept Publ Hlth, Dalgas Ave 4, DK-8000 Aarhus C, Denmark. [email protected]

    Aerobic intensity and pacing pattern during the six-minute walk test in patients with multiple sclerosis

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    OBJECTIVE: To examine the aerobic intensity level and pacing pattern during the 6-min walk test (6MWT) in persons with multiple sclerosis, taking into account time of day, fatigue, disability level and multiple sclerosis subtype. DESIGN: Cross-sectional study. Subjects/patients: Eighty multiple sclerosis patients (Expanded Disability Status Scale, EDSS ≤ 6.5). METHODS: Participants performed the 6MWT at 3 different time-points (morning, noon, afternoon) during 1 day. Heart rate and pacing strategy (distance covered every minute) were registered. A sub-group analysis determined the effects of fatigue, disability level and multiple sclerosis subtype. RESULTS: The relative aerobic intensity was constant throughout the day (67 ± 10% of estimated maximal heart rate). In all sub-groups heart rate increased and distance walked declined after the first minute (p < 0.001). The mild EDSS sub-group showed a slightly larger increase throughout the 6MWT in heart rate development, while no differences were seen in sub-groups of fatigue and multiple sclerosis subtype. In most sub-groups walking speed was fastest in the first minute and constant during the final 4 minutes. CONCLUSION: In patients with multiple sclerosis aerobic intensity is moderate during the 6MWT and unaffected by time of day. Disability may have some influence on aerobic intensity, but not on pacing strategy during the 6MWT, whereas neither fatigue nor multiple sclerosis subtype has any effect.The following 6 data-collecting out-patient centres, being REVAL Research Institute, BIOMED University of Hasselt and PHL, Belgium (n=20) and Hospital de Dia de Barcelona, Spain (n=7) and in-patient centres being Masku Neurological Rehabilitation Center, Masku, Finland (n=12); The Danish MS Hospital in Ry, Denmark (n=22); Center Neurologique et de Réadaptation Fonctionelle, Fraiture-en-Condroz, Belgium (n=14); Rehabilitation and MS Center Overpelt, Belgium (n=5) are acknowledged for their great effort. The RIMS network (www.eurims.org) is acknowledged for facilitating inter European consultation and testing. Sources of funding: DG, who coordinated most of the data collection, is recipient of a PhD Fellowship from the Research Foundation Flanders (FWO). The FWO is thanked for their Research Grant to PF, the Belgian Charcot Foundation for Equipment Grants

    Exercise therapy in multiple sclerosis: the impact of exercise intensity on glucose disposal and muscle contractile properties

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    General conclusion: In conclusion, this PhD thesis demonstrated that the prevalence of IGT in MS is higher compared to healthy subjects. Furthermore, this secondary healthy complication, as well as some clinical relevant aspects such as muscle strength, muscle mass and endurance capacity, can be improved by means of combined endurance and resistance exercise, whereas the level of improvements are dependent on the applied exercise intensity. MS also seems to negatively affect skeletal muscle fiber characteristics, muscle strength and muscle mass of, predominantly, the lower limbs of mildly affected MS patients. This can be improved by high intensity combined exercise, that was demonstrated to be safe and well tolerated in moderately affected MS patients. These results are clinically relevant because, similar to other populations, adequate exercise therapy is not only able to improve important aspects of health related fitness but is also able to counteract secondary health complications. In combination with other therapeutic strategies this probably further enhances quality of life and physical functioning of MS patients.Multiple Sclerose (MS) is een progressieve auto-immune aandoening van het centrale zenuwstelsel en wordt meestal gediagnostiseerd tussen de leeftijd van 20 en 40 jaar. Wereldwijd worden er meer dan 2,5 miljoen mensen geconfronteerd met deze ziekte. Ondanks intensief wetenschappelijk onderzoek is de onderliggende oorzaak van MS nog steeds niet volledig gekend. De variabele distributie van de schade in de myeline schede van de zenuwen kan leiden tot zeer uiteenlopende symptomen, waaronder spierzwakte en vermoeidheid. Als gevolg van deze laatstgenoemde symptomen zijn mensen met MS vaak minder fysiek actief wat resulteert in een verlies aan functionele spierkracht en inspanningscapaciteit. In andere populaties werd reeds herhaaldelijk aangetoond dat een verminderde hoeveelheid fysieke activiteit in belangrijke mate bijdraagt tot de ontwikkeling van chronische aandoeningen en het ontstaan van risico factoren die deel uitmaken van het metabole syndroom, een term die de gecombineerde aanwezigheid van verschillende cardiovasculaire risico’s, zoals verhoogde bloeddruk, glucose intolerantie en hoge cholesterol, groepeert. Zodoende komen verstoorde glucose tolerantie en insuline resistentie frequenter voor, waardoor het risico voor de ontwikkeling van type II suikerziekte en cardiovasculaire aandoeningen sterk toeneemt. Op basis van een systematische literatuur analyse kon in studie 1 worden geconcludeerd dat MS patiënten inderdaad een verhoogd risico hebben op de ontwikkeling van secundaire gezondheidsproblemen, zoals cardiovasculaire aandoeningen en het metabole syndroom in het algemeen. De methodologie van de geïncludeerde literatuur was echter meestal van een beperkte kwaliteit, waardoor het onduidelijk is waar het verhoogde risico aan toegeschreven kan worden. In een poging enkele van deze vragen te beantwoorden werd dit doctoraatsonderzoek in belangrijke mate gericht op het voorkomen en remediëren van glucose intolerantie in MS. Dit werd onderzocht in een reeks van studies, uitgevoerd bij zowel het MS proefdiermodel als bij mensen met MS

    Going Beyond Counting First Authors in Author Co-citation Analysis

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    The present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed

    Exercise therapy in multiple sclerosis: the impact of exercise intensity on glucose disposal and muscle contractile properties

    No full text
    General conclusion: In conclusion, this PhD thesis demonstrated that the prevalence of IGT in MS is higher compared to healthy subjects. Furthermore, this secondary healthy complication, as well as some clinical relevant aspects such as muscle strength, muscle mass and endurance capacity, can be improved by means of combined endurance and resistance exercise, whereas the level of improvements are dependent on the applied exercise intensity. MS also seems to negatively affect skeletal muscle fiber characteristics, muscle strength and muscle mass of, predominantly, the lower limbs of mildly affected MS patients. This can be improved by high intensity combined exercise, that was demonstrated to be safe and well tolerated in moderately affected MS patients. These results are clinically relevant because, similar to other populations, adequate exercise therapy is not only able to improve important aspects of health related fitness but is also able to counteract secondary health complications. In combination with other therapeutic strategies this probably further enhances quality of life and physical functioning of MS patients.Multiple Sclerose (MS) is een progressieve auto-immune aandoening van het centrale zenuwstelsel en wordt meestal gediagnostiseerd tussen de leeftijd van 20 en 40 jaar. Wereldwijd worden er meer dan 2,5 miljoen mensen geconfronteerd met deze ziekte. Ondanks intensief wetenschappelijk onderzoek is de onderliggende oorzaak van MS nog steeds niet volledig gekend. De variabele distributie van de schade in de myeline schede van de zenuwen kan leiden tot zeer uiteenlopende symptomen, waaronder spierzwakte en vermoeidheid. Als gevolg van deze laatstgenoemde symptomen zijn mensen met MS vaak minder fysiek actief wat resulteert in een verlies aan functionele spierkracht en inspanningscapaciteit. In andere populaties werd reeds herhaaldelijk aangetoond dat een verminderde hoeveelheid fysieke activiteit in belangrijke mate bijdraagt tot de ontwikkeling van chronische aandoeningen en het ontstaan van risico factoren die deel uitmaken van het metabole syndroom, een term die de gecombineerde aanwezigheid van verschillende cardiovasculaire risico’s, zoals verhoogde bloeddruk, glucose intolerantie en hoge cholesterol, groepeert. Zodoende komen verstoorde glucose tolerantie en insuline resistentie frequenter voor, waardoor het risico voor de ontwikkeling van type II suikerziekte en cardiovasculaire aandoeningen sterk toeneemt. Op basis van een systematische literatuur analyse kon in studie 1 worden geconcludeerd dat MS patiënten inderdaad een verhoogd risico hebben op de ontwikkeling van secundaire gezondheidsproblemen, zoals cardiovasculaire aandoeningen en het metabole syndroom in het algemeen. De methodologie van de geïncludeerde literatuur was echter meestal van een beperkte kwaliteit, waardoor het onduidelijk is waar het verhoogde risico aan toegeschreven kan worden. In een poging enkele van deze vragen te beantwoorden werd dit doctoraatsonderzoek in belangrijke mate gericht op het voorkomen en remediëren van glucose intolerantie in MS. Dit werd onderzocht in een reeks van studies, uitgevoerd bij zowel het MS proefdiermodel als bij mensen met MS
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