Randomized Controlled Trial on Cardiovascular Exercise in Uncontrolled Epilepsy: (Epilepsy)
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|ClinicalTrials.gov Identifier: NCT03570489|
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : June 29, 2018
This is an open-label randomized controlled tria testing if an improvement in cardiovascular fitness can improve quality of Life and reduce seizure frequency in patients with refractory epilepsy.. Before the intervention each subject will undergo an evaluation of baseline cardiovascular fitness. Patients will be randomized into two groups One group will listen to a relaxation tape 5 days per week for 6 months and the other group will receive a ergometric cycle and perform a predetermined level of exercise per day , 5 days per week for 6 months. Randomization will be conducted an external randomization center based on a sequence of random numbers.
Changes in concomitant antiepileptic drugs (AED) treatment during the study will be minimized, and restricted to AED changes deemed to be necessary to address AED-related toxicity.
All subjects (N=100) in both groups will be provided with an Empatica E4 watch, which permits continuous monitoring of (i) blood volume pulse; (ii) inter beat interval time; (iii) electrodermal activity; (iv) movement as recorded by an accelerometer and (v) skin temperature. E4 measures will permit to check the level of the subject's physical activity (including compliance with exercise requirements) as well parameters related to seizure activity.
Medical examination; body weight; fitness test, including ECG and BP measurements, seizure frequency; adverse effects (unstructured interview); details of concomitant concomitant treatment, mood assessment by using the Hospital Anxiety and Depression Scale-Anxiety (HADS); health related quality of life (RAND-36), E4-data downloading, will be done at baseline and after 6 months
Primary endpoint: Proportion of patients with at least 50% seizure reduction
Secondary endpoints: Median percent reduction in seizure frequency, HADS score, RAND-36 score, fitness score; adverse events, changes in concomitant AED treatment, E4 data
|Condition or disease||Intervention/treatment||Phase|
|Refractory Epilepsy||Behavioral: Exercise Behavioral: Relaxation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open label randomized parallel design|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study of the Effect of Cardiovascular Exercise in Uncontrolled Epilepsy: Efficacy, Side Effects and Quality of Life|
|Estimated Study Start Date :||August 30, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Exercise
Use of an ergometric bicycle where patients will bicycle 5 Days a week for 20 minutes at a predetermine level
Patients will bicycle for 20 minutes per day for 5 days per week for 6 months
Other Name: cardiovascular fitness
Sham Comparator: Relaxation
Patients will listen to a relaxation exercise involving muscle relaxation. This takes about 20 minutes and will be performed 5 Days/week
Patients will listen to a relaxation tape 20 minutes per day 5 Days a week for 6 months
- Proportion of patients with at least 50% seizure reduction [ Time Frame: Change from baseline at 6months ]Determined by seizure diary
- Change in anxiety and depression ratings [ Time Frame: Change from Baseline at 6 months ]Reduction in Hospital Anxiety and Depression Scale (HAD) scores.The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3. A total score can be between 0 and 21 for either anxiety or depression. A lower score indicates less depression or anxiety: a cut-off point of 8/21 indicates the presence of anxiety or depression
- Change in Health-Related Quality of Life [ Time Frame: Change from Baseline at 6 months ]Improvement in "RAND-36 -Measure of Health Related Quality of Life" version called Item Health Survey (Version 1.0) score. There are 8 domains with 36 items in total. The eight health concepts are: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In a second step, items in the same scale are averaged together to create the 8 scale scores. Scores represent the percentage of total possible score achieved.
- Reduction in adverse event reporting [ Time Frame: Improvement from baseline at 6 months ]Subjective reporting by patient
- Median percent change in seizure frequency [ Time Frame: Change from Baseline at 6 months ]Seizure Counts by seizure diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570489
|Contact: Elinor Ben-Menachem, MD,PhDemail@example.com|
|Contact: Johan Zelano, MD,PhDfirstname.lastname@example.org|
|Principal Investigator:||Elinor Ben-Menachem, MD,PhD||University of Gothenburg, Department of Clincial Neuroscience, Sahlgrenska Academy|