Randomized Controlled Trial on Cardiovascular Exercise in Uncontrolled Epilepsy:

NCT03570489 | Terminated

• 1 other identifier: ALFGBG-818131
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 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 .

Conditions

Refractory Epilepsy

Keywords

Cardiovascular fitness, refractory epilepsy,

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with at least 50% seizure reduction

  Determined by seizure diary

  Change from baseline at 6months

Secondary Outcomes (4)

• Change in anxiety and depression ratings

  Change from Baseline at 6 months

• Change in Health-Related Quality of Life

  Change from Baseline at 6 months

• Reduction in adverse event reporting

  Improvement from baseline at 6 months

• Median percent change in seizure frequency

  Change from Baseline at 6 months

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Use of an ergometric bicycle where patients will bicycle 5 Days a week for 20 minutes at a predetermine level

Behavioral: Exercise

Relaxation

SHAM COMPARATOR

Patients will listen to a relaxation exercise involving muscle relaxation. This takes about 20 minutes and will be performed 5 Days/week

Behavioral: Relaxation

Interventions

Exercise BEHAVIORAL

Patients will bicycle for 20 minutes per day for 5 days per week for 6 months

Also known as: cardiovascular fitness

Exercise

Relaxation BEHAVIORAL

Patients will listen to a relaxation tape 20 minutes per day 5 Days a week for 6 months

Relaxation

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16 years to 65 years
• An established diagnosis of focal epilepsy
• 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
• Stable AED treatment for at least 4 weeks, and no expected need to modify current AED treatment over the subsequent 6 months.
• Capability to follow instructions (or has a caretaker who will help) and keep a seizure calendar
• Ability to understand the purpose, procedures and potential risks and benefits associated with participation in the study;
• Willingness to give freely written informed consent

You may not qualify if:

• Any associated condition contraindicating non-competitive physical exercise
• Patients already engaged in regular daily physical exercise program;
• A history of seizures induced by exercise
• A history of psychogenic non-epileptic seizures
• Pregnancy or puerperium
• Alcohol or substance abuse
• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Elinor Ben-Menachem

Gothenburg, Västra Götaland County, 41345, Sweden

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elinor Ben-Menachem, MD,PhD

  University of Gothenburg, Department of Clincial Neuroscience, Sahlgrenska Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Open label randomized parallel design

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 27, 2018
• Study Start: November 30, 2018
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: November 15, 2021

Record last verified: 2019-10

Locations

SE (1)