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

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ClinicalTrials.gov Identifier: NCT02729090
Recruitment Status : Unknown
Verified March 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Device: treadmill Other: Device: treadmill Train_Comb_aerobic Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Device: treadmill
Aerobic training on a treadmill continuously with speed and wave periodization. Frequency twice per week ( 2x ) for twelve weeks
 Other: Device: treadmill
Aerobic training on a treadmill continuously with speed and wave periodization. Frequency twice per week ( 2x ) for twelve weeks. Device: treadmill.
Active Comparator: 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Cardiopulmonary test - 6 minute walk test [ Time Frame: 48 months ]
    evaluation of functional capacity


Secondary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: 48 months ]
  2. One maximum repetition test [ Time Frame: 48 months ]
  3. ankle brachial index [ Time Frame: 48 months ]
  4. Edinburgh Claudication Questionnaire [ Time Frame: 48 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729090


Contacts
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Contact: Eduardo L. Garcia, MD 0555133597634 rceduardogarcia@gmail.com
Contact: Rosane M. Nery, PhD 0555133597634 rosane.nery@gmail.com

Locations
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Brazil
Hospital De Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Eduardo L. Garcia, MD    0555198418989    rceduardogarcia@gmail.com   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Antonio C. Dos Santos, PhD Hospital de Clínicas de Porto Alegre
More Information
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Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02729090    
Other Study ID Numbers: 14-0381
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
Peripheral Arterial Disease, exercise
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases