Clinical trial NCT02729090: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease, exercise
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 .

Primary outcomes:
measure: Cardiopulmonary test - 6 minute walk test
timeFrame: 48 months
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: 48 months
measure: One maximum repetition test
timeFrame: 48 months
measure: ankle brachial index
timeFrame: 48 months
measure: Edinburgh Claudication Questionnaire
timeFrame: 48 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital De Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Antonio C. Dos Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.