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

NCT ID: NCT02729090

Last Updated: 2016-04-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-05-31

Brief Summary

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The Peripheral Arterial Disease prevalence is around 3-10 % of the world population. Exercise plays an important role in treating these patients.

Detailed Description

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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

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Device: treadmill

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

Group Type EXPERIMENTAL

Device: treadmill

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Device: treadmill Train_Comb_aerobic

Intervention Type OTHER

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

Interventions

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Device: treadmill

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

Intervention Type OTHER

Device: treadmill Train_Comb_aerobic

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

Intervention Type OTHER

Eligibility Criteria

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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 .
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio C. Dos Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital De Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Eduardo L. Garcia, MD

Role: CONTACT

0555133597634

Rosane M. Nery, PhD

Role: CONTACT

0555133597634

Facility Contacts

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Eduardo L. Garcia, MD

Role: primary

0555198418989

References

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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.

Reference Type BACKGROUND
PMID: 15886666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21676966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11358934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19141764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18505746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14981444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21540753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16730015 (View on PubMed)

Other Identifiers

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14-0381

Identifier Type: -

Identifier Source: org_study_id

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