Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity

Study Overview
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Brief Summary
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Introduction: the peripheral obstructive arterial disease is an condition that affects around 15% of the world population interfering in muscle strength, life quality and functional capacity of patients.

Detailed Description
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Study aim: to assess three methods of physical training (strength training, aerobic training and electrical stimulation training) in muscle strength, functional capacity and life quality of patients with peripheral obstructive arterial disease

Official Title
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Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity on Patients With Peripheral Artery Disease: a Randomized Clinical Trial

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Electrical Stimulation
* Other: Strength training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of PAD and IC. Age from 40 to 80 years. Stage I and II of Fontaine. Symptoms of Intermittent Claudication for at least 3 months with resting brachial index ≤ 0.90 in 1 or 2 legs Exclusion Criteria: Critical ischemia in one of the lower limbs. Moderate or severe ulcers in one of the lower limbs. Orthopedic problems that prevent exercise or evaluation. Participation in other studies with rehabilitation. Decreased arterial hypertension. Decompensated Diabetes

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical Stimulation<br>The training with electrostimulation will be performed with the following intensity: Medium frequency current: 2.500Hz Modulation frequency: up to 50Hz Time on / off: 1: 2 Average session time 10 to 15 min Being applied in the same muscle groups that will be trained in the group that will perform strength training. | Other: Electrical Stimulation<br>* electrical stimulation training<br>|
| Experimental: Strength training<br>There will be 10 exercises: upper limbs: Supine with dumbbells; High pulley pull; Alternating thread with dumbbells; Triceps dumbbell test; Lower limbs: knee extensor, squatting with body weight, plantar flexion, knee flexion and plantar dorsiflexion. The session time will be from 45 minutes to one hour 2 times weekly totaling at the end of the 12 weeks, 24 strength training sessions. | Other: Strength training<br>* strength training group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiopulmonary exercise test | assess functional capacity | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHOQOL Questionnaire | asses quality of life | 13 months | 
| Brachial ultrasonography | endothelial function | 13 months | 
| Analog scale of pain | assess pain intensity | 13 months | 
| Repetition maximum strength test (1RM) | assess Muscle strengh | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, training