A clinical trial to study the effects of lifestyle modification in obese epilepsy patients.
Phase 2
- Conditions
- Health Condition 1: null- Epilepsy & Obesity
- Registration Number
- CTRI/2014/10/005125
- Lead Sponsor
- ONE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Obese patients (BMI >29.9) with documented epilepsy
Exclusion Criteria
progressive neurological and/or systemic disorder, linguistic or cognitive inability, significant cardiovascular and/or pulmonary disorders, oncological ailments and musculoskeletal impairments for exercise. Persons where permission from the neurologist is cannot be obtained and patients with documented non-compliance to medication will also form exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body Mass Index (BMI). <br/ ><br>Girth Measurement. <br/ ><br>Body fat approximation. <br/ ><br>Resting haemodynamics and electrocardiogram. <br/ ><br>Peak expiratory flow rate / Pulmonary function testing. <br/ ><br>Supervised Six minute walk test. <br/ ><br>Timepoint: 3 months and 12 months
- Secondary Outcome Measures
Name Time Method Thyroid Profile. <br/ ><br>Lipid Profile. <br/ ><br>Fasting Blood Sugar. <br/ ><br>Quality of Life <br/ ><br>Health Enhancing Physical Activity Scores.Timepoint: 3 months and 12 months