NCT02729090

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

February 18, 2016

Last Update Submit

March 31, 2016

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease, exercise

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary test - 6 minute walk test

    evaluation of functional capacity

    48 months

Secondary Outcomes (4)

  • Pulse wave velocity

    48 months

  • One maximum repetition test

    48 months

  • ankle brachial index

    48 months

  • Edinburgh Claudication Questionnaire

    48 months

Study Arms (2)

Device: treadmill

EXPERIMENTAL

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

Other: Device: treadmill

Device: treadmill Train_Comb_aerobic

ACTIVE COMPARATOR

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.

Other: Device: treadmill Train_Comb_aerobic

Interventions

Device: treadmillOTHER

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

Device: treadmill
Device: treadmill Train_Comb_aerobicOTHER

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

Device: treadmill Train_Comb_aerobic

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital De Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (8)

  • 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.

    PMID: 15886666BACKGROUND

  • 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.

    PMID: 21676966BACKGROUND

  • 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.

    PMID: 11358934BACKGROUND

  • 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.

    PMID: 19141764BACKGROUND

  • 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.

    PMID: 18505746BACKGROUND

  • 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.

    PMID: 14981444BACKGROUND

  • 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.

    PMID: 21540753BACKGROUND

  • 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.

    PMID: 16730015BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial DiseaseMotor Activity

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesBehavior

Study Officials

  • Antonio C. Dos Santos, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo L. Garcia, MD

CONTACT

0555133597634rceduardogarcia@gmail.com

Rosane M. Nery, PhD

CONTACT

0555133597634rosane.nery@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

April 6, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

April 6, 2016

Record last verified: 2016-03

Locations

BR(1)