Exercise Training in Individuals With Peripheral Arterial Disease

University Medical Centre Ljubljana

Status: Completed

Conditions: Intermittent Claudication; Peripheral Arterial Disease

Treatments: Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02642276

UKCLRehab0022015

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Maximal walking group

Active Comparator group

Description:

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.

Treatment:

Other: Exercise training

Submaximal walking group

Active Comparator group

Description:

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.

Treatment:

Other: Exercise training

Usual care group

No Intervention group

Description:

Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.