The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
Keywords
Abstract
Dates
| Last Verified: | 06/30/2018 |
| First Submitted: | 05/27/2014 |
| Estimated Enrollment Submitted: | 05/27/2014 |
| First Posted: | 06/01/2014 |
| Last Update Submitted: | 07/27/2018 |
| Last Update Posted: | 07/30/2018 |
| Actual Study Start Date: | 11/30/2014 |
| Estimated Primary Completion Date: | 01/31/2016 |
| Estimated Study Completion Date: | 01/31/2016 |
Condition or disease
Intervention/treatment
Drug: Supervised Exercise Therapy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Supervised Exercise Therapy Standard treatment: Supervised Exercise Therapy during 12 weeks | Drug: Supervised Exercise Therapy 1000 mg of omega-3 fatty acid ethylesters, 2 times daily, for 4 weeks, followed by 12 weeks of supervised exercise therapy in combination with 2 times daily omega-3 fatty acid supplementation. |
| No Intervention: Controlled group |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Age ≥ 18 - Newly diagnosed intermittent claudication - Ankle Brachial Index < 0.8 at rest or > 0.15 decrease after exercise - Able to perform standardised treadmill walking test for 2 min - Written informed consent Exclusion Criteria: - Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language) - Heart failure or unstable cardiac status (angina pectoris class III or IV or recent myocardial infarction < 3 months) - Any illness with rapid evolution or a life expectancy < 3 months - Recent cerebrovascular accident (< 3 months) - Current use of fish oil supplements or > 2 times a week dietary fish - Pregnancy - Fish, soybean or peanut allergy - Contra indications for the use of omega-3 fatty acids - Use of oral anticoagulants (coumarin derivatives) |
Outcome
Primary Outcome Measures
1. Maximal walking distance with standardised treadmill test [After 12 weeks of supervised exercise therapy]
Secondary Outcome Measures
1. Hemorheological parameters [After 12 weeks of supervised exercise therapy]
2. Visceral fat mass [After 12 weeks of supervised exercise therapy]
3. Ex vivo cytokine production after stimulation with lipopolysaccharide [After 12 weeks of supervised exercise therapy]
4. Assessment of the microcirculation with side stream dark field technology [After 12 weeks of supervised exercise therapy]
Other Outcome Measures
1. Bloodpressure, heart rate, cholesterol, triglycerides, hemoglobin, leucocytes, C-reactive protein, ankle brachial index, [After 12 weeks of supervised exercise therapy]
