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

March 21, 2017 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90640030
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio C Santos, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical Stimulation

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
electrical stimulation training
Experimental: 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.
Other: Strength training
strength training group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Antonio C Santos, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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