Treatment of the lower limb pain, which arise during the walks, for lack of circulation. Through temporary circulation interruption of upper limbs.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7tf6tm
• Date of registration: 28/06/2012
• Primary sponsor: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - sao paulo , SP, Brazil
• Public title: Treatment of the lower limb pain, which arise during the walks, for lack of circulation. Through temporary circulation interruption of upper limbs.
• Scientific title: Remote ischemic preconditioning in patients with intermittent claudication - RIPCC: Remote ischemic preconditioning in patients with intermittent claudication
• Date of first enrolment: 05/01/2011
• Target sample size: 52
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7tf6tm/
• Study design: Trial, three-arms, controlled nonrandomized, open.

Countries of recruitment

Brazil

Contacts

• Name: Nelson Wolosker
• Affiliation: Hospital Israelita Albert Einstein

• Name: GLAUCO SAES
• Affiliation: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Key inclusion & exclusion criteria

Inclusion criteria: this study recruited patients complaining of typical intermitent claudication (IC) in one or both lower limbs, associated with absence or reduction of arterial pulses in the symptomatic member and/or ankle-brachial index < 0.90. Physical examination of the upper limbs was normal in all study participants.
Exclusion criteria: Arterial occlusion of both upper
Presence of critical ischemia of lower limbs, characterized by pain at rest or ischemic ulcerations existence of the same.
Inability to perform the treadmill test for reasons other than the intermittent claudication, as changes rheumatologic, orthopedic, neurological, cardiac or respiratory
Having used the following drugs in the last two hours before inclusion in the study: cilostazol, sildenafil, dipyridamole, glibenclamide, aminophylline, nicorandil, phenylephrine, angiotensin-converting enzyme inhibitors, angiotensin receptor blocker II, statins, alcohol, steroids, red wine.
Having consumed a quantity of coffee that means a caffeine intake ? 4mg/kg (approximately 400 ml of coffee brewed in coffee maker) in the last two hours prior to study entry


Age minimum: 0
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

I00-I99

Remote Ischemic Preconditioning Intermittent Claudication Peripheral Arterial Disease
I73.9

Intervention(s)

Fifty-two patients will be divided into three qrupos, respectively: A, B and C (control group).
In groups A and B will apply two tests on a treadmill with an interval of seven days between each test, which will be reported in the initial claudication distance and maximum distance traveled by patients.
One of the tests will be ninety minutes after completion of remote ischemic preconditioning and the other without the remote ischemic.
Many patients usually go over the second time that the treadmill test performed, by a learning effect. The A group will do the treadmill test on the first day without the remote ischemic preconditioning and the seventh day they will do the treadmill test after were submitted to the remote ischemic preconditioning. In group B the opposite will apply on the first day they will do remote ischemic pre-conditioning + treadmill test and on the seventh day only the treadmill test, without the remote ischemic preconditioning.
The patients in group C (control), will do only the treadmill tests, with an interval of 7 days between them, without remote ischemic pre-conditioning.
The procedure for remote ischemic preconditioning shall be performed according to the protocol already established in other publications. A blood pressure cuff will be maintained at a constant pressure of 200 mmHg in the proximal third of the non-dominant arm of the patient by an interval of 5 minutes. Next will be kept deflated for 5 minutes. This cycle of inflation and deflation is repeated 2 more times.
The treadmill test is performed according to the protocol described by Gardner. In which the patient walks on a treadmill at a fixed speed of 3.2 km / h, initially in the horizontal plane, whose inclination is being increased by 2% every 2 minutes test. This ends when the patient stops walking because of claudication pain intensity.
Will be measured initial claudication distance, when the patient begins to complain of the leg pain, and the maximum di

Primary Outcome(s)

The final analysis will be performed to compare the initial walk distance and total walk distance, in traedmill, observed before and after ischemic preconditioning, with each patient his own control.

Secondary Outcome(s)

Also will be investigated a correlation between the variations found in the claudication distances and ankle - brachial index of the patients

Secondary ID(s)

0853.0.015.000.07

1005/7

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo - São Paulo, SP, Brazil

Secondary Sponsor(s)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - sao paulo , SP, Brazil