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AzTrials

Peripheral Arterial DiseaseNCT02642276

Exercise Training in Individuals With Peripheral Arterial Disease

A study testing Exercise training in people with Peripheral Arterial Disease and Intermittent Claudication, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSlovenia
Study dates
Jun 2015to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosed peripheral arterial disease,
  • Fontaine stage II,
  • not included in a cardiovascular rehabilitation programme for at least 3 months.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Slovenia1 site

  • University Medical Centre Ljubljana

    Ljubljana

Other trials in Slovenia

About this study

Official title: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters 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.

Read the 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.

Being tested
Exercise training
Keywords
exercise training
Medical subject headings
Peripheral Arterial Disease, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise trainingOther

    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.

Study groups in NCT02642276
Study groupRoleWhat they receive
Maximal walking groupActive comparatorPatients 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.
Receives: Other: Exercise training
Submaximal walking groupActive comparatorPatients 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.
Receives: Other: Exercise training
Usual care groupNo interventionPatients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of maximum walking distance, measured in metres

    Determined by treadmill walking test.

    Measured: 3 months

Secondary outcomes (9)

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

    Measured: 3 months

  2. Change of the arterial stiffness coefficient

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

  8. Change of the ECG waves

    Estimated with digital high-resolution ECG

    Measured: 3 months

  9. Change of the heart rate variability

    Estimated with digital high-resolution ECG

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02642276
Sponsor's protocol ID
UKCLRehab0022015
Status last verified
Sep 2017
First submitted
20 Dec 2015
Last updated
21 Sep 2017
Results posted
No

Publications

  • Januszek R, Mika P, Konik A, Petriczek T, Nowobilski R, Nizankowski R. Effect of treadmill training on endothelial function and walking abilities in patients with peripheral arterial disease. J Cardiol. 2014 Aug;64(2):145-51. doi: 10.1016/j.jjcc.2013.12.002. Epub 2014 Jan 14.

    PubMed 24438856

  • Mika P, Konik A, Januszek R, Petriczek T, Mika A, Nowobilski R, Nizankowski R, Szczeklik A. Comparison of two treadmill training programs on walking ability and endothelial function in intermittent claudication. Int J Cardiol. 2013 Sep 30;168(2):838-42. doi: 10.1016/j.ijcard.2012.10.003. Epub 2012 Oct 30.

    PubMed 23117015

  • Delaney CL, Miller MD, Allan RB, Spark JI. The impact of different supervised exercise regimens on endothelial function in patients with intermittent claudication. Vascular. 2015 Dec;23(6):561-9. doi: 10.1177/1708538114558329. Epub 2014 Nov 18.

    PubMed 25406267

  • McDermott MM, Greenland P, Green D, Guralnik JM, Criqui MH, Liu K, Chan C, Pearce WH, Taylor L, Ridker PM, Schneider JR, Martin G, Rifai N, Quann M, Fornage M. D-dimer, inflammatory markers, and lower extremity functioning in patients with and without peripheral arterial disease. Circulation. 2003 Jul 1;107(25):3191-8. doi: 10.1161/01.CIR.0000074227.53616.CC. Epub 2003 Jun 16.

    PubMed 12810614

  • Mika P, Wilk B, Mika A, Marchewka A, Nizankowski R. The effect of pain-free treadmill training on fibrinogen, haematocrit, and lipid profile in patients with claudication. Eur J Cardiovasc Prev Rehabil. 2011 Oct;18(5):754-60. doi: 10.1177/1741826710389421. Epub 2011 Feb 9.

    PubMed 21450630

  • Schlager O, Hammer A, Giurgea A, Schuhfried O, Fialka-Moser V, Gschwandtner M, Koppensteiner R, Steiner S. Impact of exercise training on inflammation and platelet activation in patients with intermittent claudication. Swiss Med Wkly. 2012 Aug 14;142:w13623. doi: 10.4414/smw.2012.13623. eCollection 2012.

    PubMed 22893497

  • Parmenter BJ, Dieberg G, Phipps G, Smart NA. Exercise training for health-related quality of life in peripheral artery disease: a systematic review and meta-analysis. Vasc Med. 2015 Feb;20(1):30-40. doi: 10.1177/1358863X14559092. Epub 2014 Nov 28.

    PubMed 25432991

  • Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. doi: 10.1016/j.jvs.2005.05.049.

    PubMed 16242558

  • Novakovic M, Krevel B, Rajkovic U, Vizintin Cuderman T, Jansa Trontelj K, Fras Z, Jug B. Moderate-pain versus pain-free exercise, walking capacity, and cardiovascular health in patients with peripheral artery disease. J Vasc Surg. 2019 Jul;70(1):148-156. doi: 10.1016/j.jvs.2018.10.109. Epub 2019 Mar 25.

    PubMed 30922760

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Peripheral Arterial Disease and Intermittent Claudication, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of maximum walking distance, measured in metres (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02642276, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.

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