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Trial record 56 of 10364 for:    strength

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092336
Recruitment Status : Unknown
Verified March 2017 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Electrical Stimulation Other: Strength training Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. cardiopulmonary exercise test [ Time Frame: 13 months ]
    assess functional capacity


Secondary Outcome Measures :
  1. WHOQOL Questionnaire [ Time Frame: 13 months ]
    asses quality of life

  2. Brachial ultrasonography [ Time Frame: 13 months ]
    endothelial function

  3. Analog scale of pain [ Time Frame: 13 months ]
    assess pain intensity

  4. Repetition maximum strength test (1RM) [ Time Frame: 13 months ]
    assess Muscle strengh



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03092336


Contacts
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Contact: Márcio Garcia, MD 05551597634 mgmarciogarcia@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, 90640030
Contact: Márcio Garcia, MD    0555133597434    mgmarciogarcia@gmail.com   
Contact: Rosane M Nery, PhD    0555133597634    rosane.nery@gmail.com   
Principal Investigator: Antonio C Santos, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Antonio C Santos, PhD Hospital de Clínicas de Porto Alegre

Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03092336     History of Changes
Other Study ID Numbers: 11-0566
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Peripheral Arterial Disease, training
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases