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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02729090
• Other study ID #: 14-0381
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 31, 2016
• Start date: May 2015
• Est. completion date: May 2019

Study information

• Verified date: March 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Eduardo L. Garcia, MD
• Phone: 0555133597634
• Email: rceduardogarcia[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 .

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Device: treadmill
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
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

Locations

Country	Name	City	State
Brazil	Hospital De Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. Epub 2006 May 26. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary test - 6 minute walk test	evaluation of functional capacity	48 months	No
Secondary	Pulse wave velocity		48 months	No
Secondary	One maximum repetition test		48 months	No
Secondary	ankle brachial index		48 months	No
Secondary	Edinburgh Claudication Questionnaire		48 months	No