The Effectiveness of Therapeutic Physical Exercise in Patients with Amyotrophic Lateral Sclerosis in Relation to the Alsfrs-R Functionality Scale: A Systematic Review

What do you want to do ?New mailCopyBackground: to analyze the changes that a therapeutic physical exercise program is capable of causing in the functionality of patients suffering from ALS and in addition, to analyze the respiratory capacity. Methods: a systematic review of the PubMed, SCOPUS, Cochrane, SciELO, PEDro, CINAHL and MEDline databases is carried out. The information was filtered using the following MeSH terms: "Amyotrophic lateral sclerosis", "Physical Therapy", "Physical and Rehabilitation Medicine". Clinical trials published in the last 5 years were included in which one of the interventions was therapeutic physical exercise in patients with ALS, which included the ALSFRS-R as a result variable. Results: 10 clinical trials with a total of 421 patients were analyzed, of which 183 underwent rehabilitation with physical exercise and were part of the case group; the rest belong to the control group and their treatment was mostly passive. The observed trend is of a decrease of approximately 6 points in the ALSFRS-R scale at 6 months in the case groups; however, no behavior pattern was met in the controls. Conclusions: Therapeutic physical exercise could contribute to slow down the deterioration of the musculature of people with ALS, thus facilitating the performance of their daily activities.

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The Effectiveness of Therapeutic Physical Exercise in Patients with Amyotrophic Lateral Sclerosis in Relation to the Alsfrs-R Functionality Scale: A Systematic Review

10.20944/preprints202011.0540.v1 ◽

2020 ◽

Author(s):

Laura Ortega-Hombrados ◽

Guadalupe Molina Torres ◽

Alejandro Galán-Mercant ◽

Eduardo Sánchez-Guerrero ◽

Manuel Gonzalez-Sanchez ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Amyotrophic Lateral Sclerosis ◽

Physical Exercise ◽

Behavior Pattern ◽

Exercise Program ◽

Control Group ◽

Case Group ◽

Mesh Terms ◽

Lateral Sclerosis

Background: to analyze the changes that a therapeutic physical exercise program is capable of causing in the functionality of patients suffering from ALS and in addition, to analyze the respiratory capacity. Methods: a systematic review of the PubMed, SCOPUS, Cochrane, SciELO, PEDro, CINAHL and MEDline databases is carried out. The information was filtered using the following MeSH terms: "Amyotrophic lateral sclerosis", "Physical Therapy", "Physical and Rehabilitation Medicine". Clinical trials published in the last 5 years were included in which one of the interventions was therapeutic physical exercise in patients with ALS, which included the ALSFRS-R as a result variable. Results: 10 clinical trials with a total of 421 patients were analyzed, of which 183 underwent rehabilitation with physical exercise and were part of the case group; the rest belong to the control group and their treatment was mostly passive. The observed trend is of a decrease of approximately 6 points in the ALSFRS-R scale at 6 months in the case groups; however, no behavior pattern was met in the controls. Conclusions: Therapeutic physical exercise could contribute to slow down the deterioration of the musculature of people with ALS, thus facilitating the performance of their daily activities.What do you want to do ?New mailCopy

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Systematic Review of Therapeutic Physical Exercise in Patients with Amyotrophic Lateral Sclerosis over Time

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18031074 ◽

2021 ◽

Vol 18 (3) ◽

pp. 1074

Author(s):

Laura Ortega-Hombrados ◽

Guadalupe Molina-Torres ◽

Alejandro Galán-Mercant ◽

Eduardo Sánchez-Guerrero ◽

Manuel González-Sánchez ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Amyotrophic Lateral Sclerosis ◽

Physical Exercise ◽

Internal Validity ◽

Outcome Variable ◽

Subjective Perception ◽

Mesh Terms ◽

Lateral Sclerosis

Background: the main objective of this study was to analyze the potential short-, medium- and long-term effects of a therapeutic physical exercise (TFE) programme on the functionality of amyotrophic lateral sclerosis (ALS) patients, measured with the Revised Amyotrophic Lateral Sclerosis Functional Scale (ALSFRS-R) scale. Methods: a systematic review of the PubMed, SCOPUS, Cochrane, Scientific Electronic Library Online (Scielo), Physiotherapy Evidence Database (PEDro), Cumulative Index of Nursing and Allied Health Literature (CINAHL) and Medical Literature Analysis and Retrieval System Online (MEDline) databases was carried out. The information was filtered using the following Medical Subjects Heading (MeSH) terms: “Amyotrophic lateral sclerosis”, “Physical Therapy”, and “Physical and Rehabilitation Medicine”. The internal validity of the selected documents was evaluated using the PEDro scale. The study included clinical trials published in the last 5 years in which one of the interventions was therapeutic physical exercise in patients with ALS, using the ALSFRS-R as the main outcome variable and functional variables as secondary variables. Results: 10 clinical trials were analyzed, with an internal validity of 5–7 points. The TFE groups showed significant short-, medium- and long-term differences, obtaining a mean difference of 5.8 points compared to the 7.6 points obtained by the control groups, at six months, measured with ALSFRS-R. In addition, the participants showed significant improvements in functional abilities in the short, medium and long terms. Conclusions: Therapeutic physical exercise could contribute to slowing down the deterioration of the musculature of patients with ALS, thus facilitating their performance in activities of daily living, based on the significant differences shown by these individuals in the short, medium and long term both in subjective perception, measured with ALSFRS-R, and functional capacities.

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Design and analysis of a clinical trial using previous trials as historical control

Clinical Trials ◽

10.1177/1740774519858914 ◽

2019 ◽

Vol 16 (5) ◽

pp. 531-538 ◽

Cited By ~ 6

Author(s):

David Alan Schoenfeld ◽

Dianne M Finkelstein ◽

Eric Macklin ◽

Neta Zach ◽

David L Ennist ◽

...

Keyword(s):

Clinical Trials ◽

Amyotrophic Lateral Sclerosis ◽

Sample Size ◽

Standard Error ◽

Controlled Trial ◽

Sample Size Calculation ◽

Control Group ◽

Controlled Trials ◽

Number Of Patients ◽

Lateral Sclerosis

Background/AimsFor single arm trials, a treatment is evaluated by comparing an outcome estimate to historically reported outcome estimates. Such a historically controlled trial is often analyzed as if the estimates from previous trials were known without variation and there is no trial-to-trial variation in their estimands. We develop a test of treatment efficacy and sample size calculation for historically controlled trials that considers these sources of variation.MethodsWe fit a Bayesian hierarchical model, providing a sample from the posterior predictive distribution of the outcome estimand of a new trial, which, along with the standard error of the estimate, can be used to calculate the probability that the estimate exceeds a threshold. We then calculate criteria for statistical significance as a function of the standard error of the new trial and calculate sample size as a function of difference to be detected. We apply these methods to clinical trials for amyotrophic lateral sclerosis using data from the placebo groups of 16 trials.ResultsWe find that when attempting to detect the small to moderate effect sizes usually assumed in amyotrophic lateral sclerosis clinical trials, historically controlled trials would require a greater total number of patients than concurrently controlled trials, and only when an effect size is extraordinarily large is a historically controlled trial a reasonable alternative. We also show that utilizing patient level data for the prognostic covariates can reduce the sample size required for a historically controlled trial.ConclusionThis article quantifies when historically controlled trials would not provide any sample size advantage, despite dispensing with a control group.

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Association of Copper Status with Lipid Profile and Functional Status in Patients with Amyotrophic Lateral Sclerosis

Journal of Nutrition and Metabolism ◽

10.1155/2018/5678698 ◽

2018 ◽

Vol 2018 ◽

pp. 1-7 ◽

Cited By ~ 6

Author(s):

Acsa Nara A. B. Barros ◽

Mário Emílio T. Dourado ◽

Lucia de Fatima C. Pedrosa ◽

Lucia Leite-Lais

Keyword(s):

Amyotrophic Lateral Sclerosis ◽

Lipid Profile ◽

Functional Status ◽

Control Group ◽

Case Group ◽

Dietary Copper ◽

Serum Ceruloplasmin ◽

Copper Status ◽

Plasma Copper ◽

Lateral Sclerosis

Oxidative stress is one of the main mechanisms associated with the pathogenesis of amyotrophic lateral sclerosis (ALS). Copper can affect cellular oxidation and lipid metabolism. The aim of this study was to evaluate the association of copper status with lipid profile and functional status in patients with ALS. A cross-sectional study was carried out including 27 patients with ALS (case group) and 26 healthy individuals (control group). Copper status was evaluated by habitual dietary copper intake, plasma copper, and serum ceruloplasmin concentrations. The lipid profile included analysis of serum total cholesterol (TC), LDL-cholesterol (LDL-c), HDL-cholesterol (HDL-c), and triglycerides (TGL). The functional status of patients with ALS was assessed by the ALS Functional Rating Scale-Revised (ALSFRS-R). In the case group, plasma copper was lower compared with the control group (133.9 versus 164.1 μg/dL,p=0.0001) and was positively correlated with HDL-c (rs=0.398,p=0.044). In the control group, plasma copper was positively correlated with serum ceruloplasmin (rs=0.646,p<0.001), TC (rs=0.446,p=0.025), LDL-c (rs=0.445,p=0.029), and HDL-c (rs=0.479,p=0.015), and serum ceruloplasmin was positively correlated only with LDL-c (rs=0.407,p=0.043). In the case group, dietary copper intake (B=−0.373,p<0.001), plasma copper (B=−0.005,p=0.033), and TC (B=−0.312,p=0.001) were inversely associated with the functional status of patients with ALS. In contrast, serum ceruloplasmin (B=0.016,p=0.044), LDL-c (B=0.314,p=0.001), HDL-c (B=0.308,p=0.001), and TGL (B=0.062;p=0.001) were positively associated with their functional status. In conclusion, this study suggests a disturbance of copper status and its connection with the lipid profile in patients with ALS. Furthermore, copper status and lipid profile may influence the functional status of patients with ALS, standing out as potential biomarkers of disease severity.

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Statins and risk of amyotrophic lateral sclerosis: a systematic review and meta-analysis

Acta Neurologica Belgica ◽

10.1007/s13760-021-01753-8 ◽

2021 ◽

Author(s):

Fardin Nabizadeh ◽

Mohammad Balabandian ◽

Amir Mohammad Sharafi ◽

Ali Ghaderi ◽

Mohammad Reza Rostami ◽

...

Keyword(s):

Systematic Review ◽

Amyotrophic Lateral Sclerosis ◽

Meta Analysis ◽

Lateral Sclerosis

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Prevalence of pain in amyotrophic lateral sclerosis: a systematic review and meta-analysis

Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration ◽

10.1080/21678421.2021.1892765 ◽

2021 ◽

pp. 1-10

Author(s):

Naomi Hurwitz ◽

Ratko Radakovic ◽

Eleanor Boyce ◽

Guy Peryer

Keyword(s):

Systematic Review ◽

Amyotrophic Lateral Sclerosis ◽

Meta Analysis ◽

Prevalence Of Pain ◽

Lateral Sclerosis

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Improved Long-Term Survival with Edaravone Therapy in Patients with Amyotrophic Lateral Sclerosis: A Retrospective Single-Center Study in Japan

Pharmaceuticals ◽

10.3390/ph14080705 ◽

2021 ◽

Vol 14 (8) ◽

pp. 705

Author(s):

Hideki Houzen ◽

Takahiro Kano ◽

Kazuhiro Horiuchi ◽

Masahiro Wakita ◽

Azusa Nagai ◽

...

Keyword(s):

Amyotrophic Lateral Sclerosis ◽

Rank Test ◽

Positive Pressure ◽

Control Group ◽

Single Center ◽

Term Survival ◽

Long Term Survival ◽

Kaplan Meier ◽

Lateral Sclerosis

Reports on the long-term survival effect of edaravone, which was approved for the treatment of amyotrophic lateral sclerosis (ALS) in 2015 in Japan, are rare. Herein, we report our retrospective analysis of 45 consecutive patients with ALS who initially visited our hospital between 2013 and 2018. Of these, 22 patients were treated with edaravone for an average duration of 26.6 (range, 2–64) months, whereas the remaining patients were not treated with edaravone and comprised the control group. There were no differences in baseline demographics between the two groups. The primary endpoint was tracheostomy positive-pressure ventilation (TPPV) or death, and the follow-up period ended in December 2020. The survival rate was significantly better in the edaravone group than in the control group based on the Kaplan–Meier analysis, which revealed that the median survival durations were 49 (9–88) and 25 (8–41) months in the edaravone and control groups, respectively (p = 0.001, log-rank test). There were no serious edaravone-associated adverse effects during the study period. Overall, the findings of this single-center retrospective study suggest that edaravone might prolong survival in patients with ALS.

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A systematic review of non-motor symptom evaluation in clinical trials for amyotrophic lateral sclerosis

Journal of Neurology ◽

10.1007/s00415-021-10651-1 ◽

2021 ◽

Author(s):

Emily Beswick ◽

Deborah Forbes ◽

Zack Hassan ◽

Charis Wong ◽

Judith Newton ◽

...

Keyword(s):

Clinical Trials ◽

Amyotrophic Lateral Sclerosis ◽

Sleep Disturbances ◽

Neuropsychiatric Symptoms ◽

Behavioural Change ◽

Motor Symptom ◽

Motor Symptoms ◽

Behavioural Changes ◽

Non Motor Symptoms ◽

Lateral Sclerosis

Abstract Background Amyotrophic lateral sclerosis (ALS) is increasingly recognised as a multi-system disorder, presenting with common and impactful non-motor symptoms, such as neuropsychiatric symtpoms, cognitive and behavioural changes, pain, disordered sleep, fatigue and problematic saliva. Aim/hypothesis We aimed to systematically review 25 years of ALS clinical trials data to identify if non-motor features were evaluated, in addition to the traditional measures of motor functioning and survival, and where evaluated to describe the instruments used to assess. We hypothesised that assessment of non-motor symptoms has been largely neglected in trial design and not evaluated with ALS-suitable instruments. Methods We reviewed clinical trials of investigative medicinal products in ALS, since the licensing of riluzole in 1994. Trial registry databases including WHO International Trials Registry, European Clinical Trials Register, clinicaltrials.gov, and PubMed were systematically searched for Phase II, III or IV trials registered, completed or published between 01/01/1994 and 16/09/2020. No language restrictions were applied. Results 237 clinical trials, including over 29,222 participants, were investigated for their use of non-motor outcome measures. These trials evaluated neuropsychiatric symptoms (75, 32%), cognitive impairment (16, 6.8%), behavioural change (34, 14%), pain (55, 23%), sleep disturbances (12, 5%) and fatigue (18, 8%). Problematic saliva was assessed as part of composite ALS-FRS(R) scores in 184 trials (78%) but with no focus on this as an isolated symptom. 31 (13%) trials including 3585 participants did not include any assessment of non-motor symptoms. Conclusions Non-motor symptoms such as neuropsychiatric, cognitive and behavioural changes, pain, disordered sleep, fatigue, and problematic saliva have not been consistently evaluated in trials for people with ALS. Where evaluated, non-symptoms were primarily assessed using instruments and impairment thresholds that are not adapted for people with ALS. Future trials should include non-motor symptom assessments to evaluate the additional potential therapeutic benefit of candidate drugs. PROPSERO registration CRD42020223648.

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