The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication

Study Overview
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Brief Summary
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Intermittent claudication (IC) is caused by peripheral arterial disease and has a high morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease. Primary treatment consists of cardiovascular risk management and improvement of functional capacity with supervised exercise therapy (SET). A potential additional therapy is the administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved hemorheological parameters such as erythrocyte deformability and aggregation, and a number of cardiovascular risk factors. Hemorheological parameters determine the blood flow in the microcirculation, which is of main importance in patients with IC since the macrocirculation is compromised. Inflammation is considered an important etiologic factor in the pathogenesis of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also have a strong anti-inflammatory effect, they might be effective in patients with IC by lowering the inflammatory response. In addition, visceral fat rather than obesity in general has been recognised as an etiologic and prognostic factor in atherosclerosis. We hypothesise that the administration of omega-3 PUFA's in patients with IC has a synergistic effect with SET and improves walking distance after SET, by improving hemorheological parameters resulting in a better microcirculation. Second, we hypothesise that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a decrease in visceral fat mass.

Official Title
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The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication

Conditions
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Intermittent Claudication

Intervention / Treatment
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* Drug: Omega-3 fatty acids


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supervised Exercise Therapy<br>Standard treatment: Supervised Exercise Therapy during 12 weeks | Drug: Omega-3 fatty acids<br>* 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.<br>* Other names: Fish oil supplements;|
| No Intervention: Controlled group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal walking distance with standardised treadmill test |  | After 12 weeks of supervised exercise therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorheological parameters |  | After 12 weeks of supervised exercise therapy | 
| Visceral fat mass |  | After 12 weeks of supervised exercise therapy | 
| Ex vivo cytokine production after stimulation with lipopolysaccharide |  | After 12 weeks of supervised exercise therapy | 
| Assessment of the microcirculation with side stream dark field technology |  | After 12 weeks of supervised exercise therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish oil supplements, Supervised Exercise Training, Walking distance, Hemorheological factors, Cardiovascular risk