Exercise Training in Individuals With Peripheral Arterial Disease

Study Overview
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Brief Summary
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In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.

Detailed Description
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Exercise training (walking) is a recommended therapeutic intervention for patients with peripheral arterial disease (PAD). Studies have shown that exercise training improves walking distance, pain-free walking distance, endothelial function and quality of life in these patients. However, to date the most effective exercise training option in terms of improvement of cardiovascular parameters has not been clearly identified. In this controlled trial, patients with PAD will be randomized to either maximal walking group, submaximal walking group, or usual care. The aim of the study is to compare the effect of maximal vs. submaximal walking training programmes on i) walking ability, ii) vascular function, iii) arrhythmogenic potential, iv) parameters of inflammation, hemostasis and heart failure severity, v) health-related quality of life in individuals with PAD.

Official Title
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Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Individuals With Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease, Intermittent Claudication

Intervention / Treatment
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* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed peripheral arterial disease, Fontaine stage II, not included in a cardiovascular rehabilitation programme for at least 3 months. Exclusion Criteria: contraindications for physical activity, uncontrolled dysrhythmias, uncontrolled heart failure (New York Heart Association (NYHA) stage IV), unstable coronary or other arterial disease, intellectual development disorder, pregnancy.

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: Maximal walking group<br>Patients to be randomized to the 'maximal walking group' will have exercise training sessions 3 times per week for a period of 12 weeks. They will undergo an exercise training programme consisting of 60 minutes of repetitive interval muscle training/walking up to the point of pain-free walking distance. | Other: Exercise training<br>* Patients to be randomized to the 'maximal walking group' or 'submaximal group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.<br>|
| Active Comparator: Submaximal walking group<br>Patients to be randomized to the 'submaximal walking group' will have exercise training sessions 3 times per week for a period of 12 weeks. They will undergo an exercise training programme consisting of 60 minutes of repetitive interval muscle training/walking up to 2/3 of pain-free walking distance. | Other: Exercise training<br>* Patients to be randomized to the 'maximal walking group' or 'submaximal group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.<br>|
| No Intervention: Usual care group<br>Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximum walking distance, measured in metres | Determined by treadmill walking test. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of flow-mediated dilatation of the brachial artery, measured in % |  | 3 months | 
| Change of the arterial stiffness coefficient |  | 3 months | 
| Change of the value of blood C-reactive protein, measured in mg/l |  | 3 months | 
| Change of the value of blood fibrinogen, measured in g/l |  | 3 months | 
| Change of the value of blood D-dimer, measured in microg/l |  | 3 months | 
| Change of the value of blood N terminal-proBNP, measured in ng/l |  | 3 months | 
| Change of from-the-questionnaire-obtained quality of life, measured in points |  | 3 months | 
| Change of the ECG waves | Estimated with digital high-resolution ECG | 3 months | 
| Change of the heart rate variability | Estimated with digital high-resolution ECG | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise training