Exercise Training in Individuals With Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Interventions: Other: Exercise training

• Registration Number: NCT02642276
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-12-20
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-30
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maximal walking group	Exercise training	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.
Submaximal walking group	Exercise training	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.

Primary Outcome Measures

Name	Time	Method
Change of maximum walking distance, measured in metres	3 months	Determined by treadmill walking test.

Secondary Outcome Measures

Name	Time	Method
Change of flow-mediated dilatation of the brachial artery, measured in %	3 months
Change of the value of blood C-reactive protein, measured in mg/l	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 arterial stiffness coefficient	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 from-the-questionnaire-obtained quality of life, measured in points	3 months
Change of the value of blood N terminal-proBNP, measured in ng/l	3 months

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia