Exercise Training in Individuals With Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642276
• Other study ID #: UKCLRehab0022015
• Status: Completed
• Phase: N/A
• First received: December 20, 2015
• Last updated: September 19, 2017
• Start date: June 2015
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Exercise training
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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (8)

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. — View 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. — View 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. — View 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. Epub 2003 Jun 16. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of maximum walking distance, measured in metres	Determined by treadmill walking test.	3 months
Secondary	Change of flow-mediated dilatation of the brachial artery, measured in %		3 months
Secondary	Change of the arterial stiffness coefficient		3 months
Secondary	Change of the value of blood C-reactive protein, measured in mg/l		3 months
Secondary	Change of the value of blood fibrinogen, measured in g/l		3 months
Secondary	Change of the value of blood D-dimer, measured in microg/l		3 months
Secondary	Change of the value of blood N terminal-proBNP, measured in ng/l		3 months
Secondary	Change of from-the-questionnaire-obtained quality of life, measured in points		3 months
Secondary	Change of the ECG waves	Estimated with digital high-resolution ECG	3 months
Secondary	Change of the heart rate variability	Estimated with digital high-resolution ECG	3 months