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Exercise Training in Individuals With Peripheral Arterial Disease

NCT ID: NCT02642276

Last Updated: 2017-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Peripheral Arterial Disease Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maximal walking group

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.

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type 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.

Submaximal walking group

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.

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type 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.

Usual care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Borut Jug

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Borut Jug, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana, Slovenia

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type BACKGROUND
PMID: 24438856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23117015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25406267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12810614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21450630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22893497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25432991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16242558 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30922760 (View on PubMed)

Other Identifiers

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UKCLRehab0022015

Identifier Type: -

Identifier Source: org_study_id