Intermittent Claudication, Peripheral Arterial Disease
Conditions
Keywords
exercise training
Brief summary
In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.
Detailed description
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.
Interventions
OTHERExercise training
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.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of maximum walking distance, measured in metres | 3 months | Determined by treadmill walking test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 flow-mediated dilatation of the brachial artery, measured in % | 3 months | — |
| Change of from-the-questionnaire-obtained quality of life, measured in points | 3 months | — |
| Change of the ECG waves | 3 months | Estimated with digital high-resolution ECG |
| Change of the heart rate variability | 3 months | Estimated with digital high-resolution ECG |
| Change of the value of blood N terminal-proBNP, measured in ng/l | 3 months | — |
Countries
Slovenia
Outcome results
None listed