Clinical trial NCT02642276: Exercise Training in Individuals With Peripheral Arterial Disease
Official title: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Individuals With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Keywords: exercise training
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of maximum walking distance, measured in metres
timeFrame: 3 months
Secondary outcomes:
measure: Change of flow-mediated dilatation of the brachial artery, measured in %
timeFrame: 3 months
measure: Change of the arterial stiffness coefficient
timeFrame: 3 months
measure: Change of the value of blood C-reactive protein, measured in mg/l
timeFrame: 3 months
measure: Change of the value of blood fibrinogen, measured in g/l
timeFrame: 3 months
measure: Change of the value of blood D-dimer, measured in microg/l
timeFrame: 3 months
measure: Change of the value of blood N terminal-proBNP, measured in ng/l
timeFrame: 3 months
measure: Change of from-the-questionnaire-obtained quality of life, measured in points
timeFrame: 3 months
measure: Change of the ECG waves
timeFrame: 3 months
measure: Change of the heart rate variability
timeFrame: 3 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana, Slovenia
name: Borut Jug, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.