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History of vigorous leisure-time physical activity and early onset amyotrophic lateral sclerosis (ALS), data from the national ALS registry: 2010-2018.

ABSTRACT: Background: Previous research has suggested that vigorous physical activity (VPA) during adolescence and early adulthood is associated with ALS. The National ALS Registry (Registry) collects physical activity data from persons with ALS. Objective: To examine the association between vigorous VPA and early onset ALS, defined as a diagnosis before age 60, among patients enrolled in the Registry. VPA was defined as engaging in dynamic exercise for at least 10 minutes in a session that caused heavy sweating or large increases in breathing or heart rate. Methods: A cross-sectional study was conducted of 5463 ALS patients with VPA history and 956 ALS patients who never engaged in VPA. Patient characteristics were collected via online surveys in the following areas: demographic, lifetime VPA history, and initial onset of symptoms. General linear modeling was used to estimate mean age of diagnosis and to compute 95% confidence intervals. Results: Patients who reported engaging in VPA at least moderately (three times a week) during early adulthood were more likely to have an ALS diagnosis earlier compared to patients who did not (p < 0.0001). After controlling for year of birth, statistically significant associations between those reporting VPA at age 15-24 and 25-34 and diagnosis of ALS earlier (p = 0.0009, p = 0.0144 respectively). Conclusion: Patients with ALS who had a history of VPA before age 35, were significantly more likely to be diagnosed with ALS before age 60 compared to patients with ALS who never engaged vigorously. More research is needed in the relationship between VPA and early onset ALS.

SUBMITTER: Raymond J

PROVIDER: S-EPMC8559906 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAmyotrophic lateral sclerosis (ALS) is a neurological disease of largely unknown etiology with no cure. The National ALS Registry is a voluntary online system that collects demographic and reproductive history (females only) data from patients with ALS. We will examine the association between demographic and reproductive history among female patients aged >18 years and various ages of onset for ALS.MethodsData from a cross-sectional study were collected and examined for 1,018 female ALS patients. Patient characteristics examined were demographics including race, BMI, and familial history of ALS. Among patients, information on reproductive history, including age at menopause, ever pregnant, and age at first pregnancy was collected. Unadjusted and adjusted logistic regression models were used to estimate OR and 95% CI in this study.ResultsWomen were more likely to be diagnosed with ALS before age 60 if they were nonwhite (p = 0.015), had attended college (p = 0.0012), had a normal BMI at age 40 (p < 0.0001), completed menopause before age 50 (p < 0.0001), and had never been pregnant (p = 0.046) in the univariate analysis. Women diagnosed with ALS before age 60 were also more likely to have limb site of onset (p < 0.0001). In the multivariate analysis, those who completed menopause before age 50 were more likely to be diagnosed with ALS before age 60 (OR = 1.8, 95% CI: 1.4-2.3) compared with women who completed menopause at or after age 50, after controlling for race, ever pregnant, age at first pregnancy, family history of ALS, education status, smoking history, and BMI at age 40. For women who were diagnosed with ALS before age 50, the odds of them entering menopause before age 50 climb to 48.7 (95% CI: 11.8, 200.9). The mean age of ALS diagnosis for women who completed menopause before age 50 was 58 years and 64 years for women who entered menopause after age 50 (p < 0.0001).ConclusionWomen who reported completing menopause before age 50 were significantly more likely to be diagnosed with ALS before age 60 compared with those who reported entering menopause after age 50. More research is needed to determine the relationship between female reproductive history, especially regarding endogenous estrogen exposure and early-onset ALS.

Project description:Thoughtful clinical trial design is critical for efficient therapeutic development, particularly in the field of amyotrophic lateral sclerosis (ALS), where trials often aim to detect modest treatment effects among a population with heterogeneous disease progression. Appropriate outcome measure selection is necessary for trials to provide decisive and informative results. Investigators must consider the outcome measure's reliability, responsiveness to detect change when change has actually occurred, clinical relevance, and psychometric performance. ALS clinical trials can also be performed more efficiently by utilizing statistical enrichment techniques. Innovations in ALS prediction models allow for selection of participants with less heterogeneity in disease progression rates without requiring a lead-in period, or participants can be stratified according to predicted progression. Statistical enrichment can reduce the needed sample size and improve study power, but investigators must find a balance between optimizing statistical efficiency and retaining generalizability of study findings to the broader ALS population. Additional progress is still needed for biomarker development and validation to confirm target engagement in ALS treatment trials. Selection of an appropriate biofluid biomarker depends on the treatment mechanism of interest, and biomarker studies should be incorporated into early phase trials. Inclusion of patients with ALS as advisors and advocates can strengthen clinical trial design and study retention, but more engagement efforts are needed to improve diversity and equity in ALS research studies. Another challenge for ALS therapeutic development is identifying ways to respect patient autonomy and improve access to experimental treatment, something that is strongly desired by many patients with ALS and ALS advocacy organizations. Expanded access programs that run concurrently to well-designed and adequately powered randomized controlled trials may provide an opportunity to broaden access to promising therapeutics without compromising scientific integrity or rushing regulatory approval of therapies without adequate proof of efficacy.

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History of vigorous leisure-time physical activity and early onset amyotrophic lateral sclerosis (ALS), data from the national ALS registry: 2010-2018.

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