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Exercise Training in Individuals With Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease, Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring exercise training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Centre Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Maximal walking group

Submaximal walking group

Usual care group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Change of maximum walking distance, measured in metres
Determined by treadmill walking test.

Secondary Outcome Measures

Change of flow-mediated dilatation of the brachial artery, measured in %
Change of the arterial stiffness coefficient
Change of the value of blood C-reactive protein, measured in mg/l
Change of the value of blood fibrinogen, measured in g/l
Change of the value of blood D-dimer, measured in microg/l
Change of the value of blood N terminal-proBNP, measured in ng/l
Change of from-the-questionnaire-obtained quality of life, measured in points
Change of the ECG waves
Estimated with digital high-resolution ECG
Change of the heart rate variability
Estimated with digital high-resolution ECG

Full Information

First Posted
December 20, 2015
Last Updated
September 19, 2017
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT02642276
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Intermittent Claudication
Keywords
exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maximal walking group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Submaximal walking group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of maximum walking distance, measured in metres
Description
Determined by treadmill walking test.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of flow-mediated dilatation of the brachial artery, measured in %
Time Frame
3 months
Title
Change of the arterial stiffness coefficient
Time Frame
3 months
Title
Change of the value of blood C-reactive protein, measured in mg/l
Time Frame
3 months
Title
Change of the value of blood fibrinogen, measured in g/l
Time Frame
3 months
Title
Change of the value of blood D-dimer, measured in microg/l
Time Frame
3 months
Title
Change of the value of blood N terminal-proBNP, measured in ng/l
Time Frame
3 months
Title
Change of from-the-questionnaire-obtained quality of life, measured in points
Time Frame
3 months
Title
Change of the ECG waves
Description
Estimated with digital high-resolution ECG
Time Frame
3 months
Title
Change of the heart rate variability
Description
Estimated with digital high-resolution ECG
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borut Jug, MD, Ph.D.
Organizational Affiliation
University Medical Centre Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24438856
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.
Results Reference
background
PubMed Identifier
23117015
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.
Results Reference
background
PubMed Identifier
25406267
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.
Results Reference
background
PubMed Identifier
12810614
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.
Results Reference
background
PubMed Identifier
21450630
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.
Results Reference
background
PubMed Identifier
22893497
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.
Results Reference
background
PubMed Identifier
25432991
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.
Results Reference
background
PubMed Identifier
16242558
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.
Results Reference
background
PubMed Identifier
30922760
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.
Results Reference
derived

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Exercise Training in Individuals With Peripheral Arterial Disease

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