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Completed

NCT Number: NCT02642276

Exercise Training in Individuals With Peripheral Arterial Disease

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

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.

Primary outcomes

  1. Change of maximum walking distance, measured in metres

    Time frame: 3 months

    Determined by treadmill walking test.

Secondary outcomes

  1. Change of flow-mediated dilatation of the brachial artery, measured in %

    Time frame: 3 months

  2. Change of the arterial stiffness coefficient

    Time frame: 3 months

  3. Change of the value of blood C-reactive protein, measured in mg/l

    Time frame: 3 months

  4. Change of the value of blood fibrinogen, measured in g/l

    Time frame: 3 months

  5. Change of the value of blood D-dimer, measured in microg/l

    Time frame: 3 months

  6. Change of the value of blood N terminal-proBNP, measured in ng/l

    Time frame: 3 months

  7. Change of from-the-questionnaire-obtained quality of life, measured in points

    Time frame: 3 months

  8. Change of the ECG waves

    Time frame: 3 months

    Estimated with digital high-resolution ECG

  9. Change of the heart rate variability

    Time frame: 3 months

    Estimated with digital high-resolution ECG

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2015
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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