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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
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label randomized parallel design
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercise
Use of an ergometric bicycle where patients will bicycle 5 Days a week for 20 minutes at a predetermine level
Behavioral: Exercise
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
Behavioral: Relaxation
Patients will listen to a relaxation tape 20 minutes per day 5 Days a week for 6 months




Primary Outcome Measures :
  1. Proportion of patients with at least 50% seizure reduction [ Time Frame: Change from baseline at 6months ]
    Determined by seizure diary


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Reduction in adverse event reporting [ Time Frame: Improvement from baseline at 6 months ]
    Subjective reporting by patient

  4. Median percent change in seizure frequency [ Time Frame: Change from Baseline at 6 months ]
    Seizure Counts by seizure diary



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 16 years to 65 years
  2. An established diagnosis of focal epilepsy
  3. A frequency of at least 3 focal seizures (including focal to bilateral tonic-clonic) during a 4 week-prospective baseline, despite ongoing treatment with one to 4 AEDs
  4. Stable AED treatment for at least 4 weeks, and no expected need to modify current AED treatment over the subsequent 6 months.
  5. Capability to follow instructions (or has a caretaker who will help) and keep a seizure calendar
  6. Ability to understand the purpose, procedures and potential risks and benefits associated with participation in the study;
  7. Willingness to give freely written informed consent

Exclusion Criteria:

  1. Any associated condition contraindicating non-competitive physical exercise
  2. Patients already engaged in regular daily physical exercise program;
  3. A history of seizures induced by exercise
  4. A history of psychogenic non-epileptic seizures
  5. Pregnancy or puerperium
  6. Alcohol or substance abuse
  7. Any condition (for example, an unstable or progressive medical condition) which, in the investigator's assessment, may interfere with the evaluation procedures or the objectives of the study

Information from the National Library of Medicine

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


Contacts
Contact: Elinor Ben-Menachem, MD,PhD +46733360588 ebm@neuro.gu.se
Contact: Johan Zelano, MD,PhD +46707730675 johan.zelano@neuro.gu.se

Sponsors and Collaborators
Vastra Gotaland Region
Investigators
Principal Investigator: Elinor Ben-Menachem, MD,PhD University of Gothenburg, Department of Clincial Neuroscience, Sahlgrenska Academy

Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03570489     History of Changes
Other Study ID Numbers: ALFGBG-818131
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The plan is to share but we are uncertain just now as to how

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vastra Gotaland Region:
Cardiovascular fitness, refractory epilepsy,

Additional relevant MeSH terms:
Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases