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

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Electrical Stimulation
Strength training
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, training

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Electrical Stimulation

Strength training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

cardiopulmonary exercise test
assess functional capacity

Secondary Outcome Measures

WHOQOL Questionnaire
asses quality of life
Brachial ultrasonography
endothelial function
Analog scale of pain
assess pain intensity
Repetition maximum strength test (1RM)
assess Muscle strengh

Full Information

First Posted
March 21, 2017
Last Updated
March 21, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03092336
Brief Title
Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Arterial Disease, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Strength training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electrical Stimulation
Intervention Description
electrical stimulation training
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
strength training group
Primary Outcome Measure Information:
Title
cardiopulmonary exercise test
Description
assess functional capacity
Time Frame
13 months
Secondary Outcome Measure Information:
Title
WHOQOL Questionnaire
Description
asses quality of life
Time Frame
13 months
Title
Brachial ultrasonography
Description
endothelial function
Time Frame
13 months
Title
Analog scale of pain
Description
assess pain intensity
Time Frame
13 months
Title
Repetition maximum strength test (1RM)
Description
assess Muscle strengh
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Márcio Garcia, MD
Phone
05551597634
Email
mgmarciogarcia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rosane M Nery, PhD
Phone
0555133597634
Email
rosane.nery@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio C Santos, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90640030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Márcio Garcia, MD
Phone
0555133597434
Email
mgmarciogarcia@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosane M Nery, PhD
Phone
0555133597634
Email
rosane.nery@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonio C Santos, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity

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