NCT02642276

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

December 20, 2015

Last Update Submit

September 19, 2017

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Keywords

exercise training

Outcome Measures

Primary Outcomes (1)

  • Change of maximum walking distance, measured in metres

    Determined by treadmill walking test.

    3 months

Secondary Outcomes (9)

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

    3 months

  • Change of the arterial stiffness coefficient

    3 months

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

    3 months

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

    3 months

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

    3 months

  • +4 more secondary outcomes

Study Arms (3)

Maximal walking group

ACTIVE COMPARATOR

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.

Other: Exercise training

Submaximal walking group

ACTIVE COMPARATOR

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.

Other: Exercise training

Usual care group

NO INTERVENTION

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

Interventions

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.

Maximal walking groupSubmaximal walking group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Related Publications (9)

  • 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.

    PMID: 24438856BACKGROUND

  • 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.

    PMID: 23117015BACKGROUND

  • 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.

    PMID: 25406267BACKGROUND

  • 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.

    PMID: 12810614BACKGROUND

  • 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.

    PMID: 21450630BACKGROUND

  • 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.

    PMID: 22893497BACKGROUND

  • 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.

    PMID: 25432991BACKGROUND

  • 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.

    PMID: 16242558BACKGROUND

  • 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.

    PMID: 30922760DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Interventions

Exercise

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Borut Jug, MD, Ph.D.

    University Medical Centre Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 20, 2015

First Posted

December 30, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

SL(1)