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Cardiovascular Exercise - ClinicalTrials.gov

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Last Updated: 10 December 2021

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Randomized Controlled Study of the Effect of Cardiovascular Exercise in Uncontrolled Epilepsy: Efficacy, Side Effects and Quality of Life

Goals The main purpose of this research is to evaluate the impact of a 6-month course of standardized exercise, added to pre-existing steady AED therapy, on seizure frequency in patients with epilepsy aged 16 to 65. Prior to the treatment each topic will undergo an examination of cardiovascular fitness making use of the cycle ergometric test and his/her work level too criteria associated to seizure task. Month 6: Medical examination; body weight; fitness test, consisting of ECG and BP dimensions, seizure regularity; adverse impacts; information of concomitant treatment, mood evaluation by utilizing the Hospital Anxiety and Depression Scale-Anxiety; health and wellness relevant top quality of life, E4-data downloading, Any extra testing may be executed as taken into consideration clinically suggested by the dealing with doctor. Experience size and statistical analysis Assuming that 40% of patients in the intervention group vs. 20% of patients in the control team have a 50% or higher decrease in seizure frequency compared to baseline, 79 patients per group provide 80% power to recognize a difference in between groups at an importance degree of 0. 05. Per-protocol evaluation will exclude patients ceasing prematurely the study and patients with much less than 75% compliance with exercise demands. Before the research study, all patients will be notified regarding the goals and implications of the research, and will be asked to sign an educated approval type.

Source link: https://clinicaltrials.gov/ct2/show/NCT03570489

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions