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Effects of Exercise in the Functional Capacity, Central Artery and Rigidity Ankle Brachial Index

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Device: treadmill
Device: treadmill Train_Comb_aerobic
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of DAP and CI .
  • Stage I or II of Fontaine .
  • intermittent claudication symptoms for at least 3 months with ankle brachial index (ABI ) at rest ≤ 0.90 in 1 or 2 legs.

Exclusion Criteria:

  • Ischemia criticism in one of the lower limbs.
  • moderate or severe ulcers on one of the lower limbs.Orthopedic issues that prevent pratical of the exercises or conducting evaluations .
  • Participation in other studies with rehabilitation.
  • decompensated hypertension .
  • decompensated diabetes .
  • Cardiovascular events less than three months .
  • severe lung disease .

Sites / Locations

  • Hospital De Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device: treadmill

Device: treadmill Train_Comb_aerobic

Arm Description

Aerobic training on a treadmill continuously with speed and wave periodization. Frequency twice per week ( 2x ) for twelve weeks

strength training with free weights, followed by active recovery on a treadmill with fixed intervals of 60 to 120 seconds between each workforce of series.

Outcomes

Primary Outcome Measures

Cardiopulmonary test - 6 minute walk test
evaluation of functional capacity

Secondary Outcome Measures

Pulse wave velocity
One maximum repetition test
ankle brachial index
Edinburgh Claudication Questionnaire

Full Information

First Posted
February 18, 2016
Last Updated
March 31, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02729090
Brief Title
Effects of Exercise in the Functional Capacity, Central Artery and Rigidity Ankle Brachial Index
Official Title
Effects of Combined Force Training Aerobic Versus Aerobic in the Functional Capacity, Central Artery and Rigidity Ankle Brachial Index in Patients With Peripheral Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Peripheral Arterial Disease prevalence is around 3-10 % of the world population. Exercise plays an important role in treating these patients.
Detailed Description
Objective: To investigate the effects of training Combined Aerobic - Strength versus aerobic functional capacity, ankle brachial index (ABI ) and central arterial stiffness in patients with peripheral arterial disease

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device: treadmill
Arm Type
Experimental
Arm Description
Aerobic training on a treadmill continuously with speed and wave periodization. Frequency twice per week ( 2x ) for twelve weeks
Arm Title
Device: treadmill Train_Comb_aerobic
Arm Type
Active Comparator
Arm Description
strength training with free weights, followed by active recovery on a treadmill with fixed intervals of 60 to 120 seconds between each workforce of series.
Intervention Type
Other
Intervention Name(s)
Device: treadmill
Intervention Description
Aerobic training on a treadmill continuously with speed and wave periodization. Frequency twice per week ( 2x ) for twelve weeks. Device: treadmill.
Intervention Type
Other
Intervention Name(s)
Device: treadmill Train_Comb_aerobic
Intervention Description
Device: treadmill Train_Comb_aerobic. strength training with free weights, followed by active recovery on a treadmill with fixed intervals of 60 to 120 seconds between each workforce of series. Device: treadmill Train_Comb_aerobic
Primary Outcome Measure Information:
Title
Cardiopulmonary test - 6 minute walk test
Description
evaluation of functional capacity
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Pulse wave velocity
Time Frame
48 months
Title
One maximum repetition test
Time Frame
48 months
Title
ankle brachial index
Time Frame
48 months
Title
Edinburgh Claudication Questionnaire
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of DAP and CI . Stage I or II of Fontaine . intermittent claudication symptoms for at least 3 months with ankle brachial index (ABI ) at rest ≤ 0.90 in 1 or 2 legs. Exclusion Criteria: Ischemia criticism in one of the lower limbs. moderate or severe ulcers on one of the lower limbs.Orthopedic issues that prevent pratical of the exercises or conducting evaluations . Participation in other studies with rehabilitation. decompensated hypertension . decompensated diabetes . Cardiovascular events less than three months . severe lung disease .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo L. Garcia, MD
Phone
0555133597634
Email
rceduardogarcia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rosane M. Nery, PhD
Phone
0555133597634
Email
rosane.nery@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio C. Dos Santos, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital De Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo L. Garcia, MD
Phone
0555198418989
Email
rceduardogarcia@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15886666
Citation
Rehring TF, Sandhoff BG, Stolcpart RS, Merenich JA, Hollis HW Jr. Atherosclerotic risk factor control in patients with peripheral arterial disease. J Vasc Surg. 2005 May;41(5):816-22. doi: 10.1016/j.jvs.2005.01.047.
Results Reference
background
PubMed Identifier
21676966
Citation
Rabkin SW, Chan SH, Sweeney C. Ankle-brachial index as an indicator of arterial stiffness in patients without peripheral artery disease. Angiology. 2012 Feb;63(2):150-4. doi: 10.1177/0003319711410307. Epub 2011 Jun 15.
Results Reference
background
PubMed Identifier
11358934
Citation
Laurent S, Boutouyrie P, Asmar R, Gautier I, Laloux B, Guize L, Ducimetiere P, Benetos A. Aortic stiffness is an independent predictor of all-cause and cardiovascular mortality in hypertensive patients. Hypertension. 2001 May;37(5):1236-41. doi: 10.1161/01.hyp.37.5.1236.
Results Reference
background
PubMed Identifier
19141764
Citation
McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962. Erratum In: JAMA. 2012 Apr 25;307(16):1694.
Results Reference
background
PubMed Identifier
18505746
Citation
Wang J, Zhou S, Bronks R, Graham J, Myers S. Effects of supervised treadmill walking training on calf muscle capillarization in patients with intermittent claudication. Angiology. 2009 Feb-Mar;60(1):36-41. doi: 10.1177/0003319708317337. Epub 2008 May 27.
Results Reference
background
PubMed Identifier
14981444
Citation
Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. doi: 10.1016/j.jvs.2003.08.037.
Results Reference
background
PubMed Identifier
21540753
Citation
Figueroa A, Park SY, Seo DY, Sanchez-Gonzalez MA, Baek YH. Combined resistance and endurance exercise training improves arterial stiffness, blood pressure, and muscle strength in postmenopausal women. Menopause. 2011 Sep;18(9):980-4. doi: 10.1097/gme.0b013e3182135442.
Results Reference
background
PubMed Identifier
16730015
Citation
Brewer LC, Chai HS, Bailey KR, Kullo IJ. Measures of arterial stiffness and wave reflection are associated with walking distance in patients with peripheral arterial disease. Atherosclerosis. 2007 Apr;191(2):384-90. doi: 10.1016/j.atherosclerosis.2006.03.038. Epub 2006 May 26.
Results Reference
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Effects of Exercise in the Functional Capacity, Central Artery and Rigidity Ankle Brachial Index

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