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Effects of Respiratory Muscle Training and Respiratory Exercise in Exercise Tolerance, Performing Daily Life Activities and Quality of Life of Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01510041
Recruitment Status : Unknown
Verified January 2012 by Renata Pedrolongo Basso, Principal Investigator, Universidade Federal de Sao Carlos.
Recruitment status was:  Recruiting
First Posted : January 13, 2012
Last Update Posted : January 13, 2012
Sponsor:
Information provided by (Responsible Party):
Renata Pedrolongo Basso, Principal Investigator, Universidade Federal de Sao Carlos

Brief Summary:
In patients with chronic obstructive pulmonary disease (COPD) breaths at an abnormally high lung volume causes the inspiratory muscle to operate at non-optimal lengths, which reduce their maximal contractile forces. In addition, causes non thoraco abdominal synchronize, reduced inspiratory muscle strength and is associated with dyspnea and decreased exercise capacity. For these patients inspiratory muscle training (IMT) is a widely employed form of rehabilitation also targeting the respiratory muscle. In addition, patients often experience shortness of breath and a decline in exercise tolerance, resulting in disability in the performance of activities of daily living (ADL). The aims of this trial are to evaluate the effects of inspiratory muscle training associated with aerobic training on strength and endurance of inspiratory muscle, thoracic abdominal synchrony, exercise tolerance and quality of life patients with COPD. To compare the responses with the effects of aerobic training plus exercises of the trunk and upper limbs, and stretching of large muscle groups of the trunk. To compare difference in the perception of dyspnea during the ADL set (Borg Scale) with perception of dyspnea self-reported in the Medical Research Council (MRC), the London Chest Activity of Daily Living (LCADL) and the Pulmonary Functional Status and Dyspnea Questionnaire - Modified version (PFSDQ-M) before start the protocol. To investigate changes on perception of dyspnea (Borg scale), metabolic and ventilatory responses during a standard set of ADL tasks after a physical training and to evaluate and compare changes on perception of dyspnea. The hypothesis are that the ventilatory efficiency during the performance of ADL and the dyspnea reported from borg scale, the LCADL and the PFSDQ-M that quantifies the functional performance (change in activity levels) are improved during the IMT in conjunction with general exercise training in patients with COPD. The MIT increases the strength and endurance of inspiratory muscle, the exercise capacity and the quality of life compared to the general physical training. However, compared to the thorax abdominal synchronizes, higher modification is verified in the general physical training group with specific exercise to torso, limbs and stretching of the higher muscle group.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Inspiratory muscle training Other: Respiratory exercise Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Respiratory Muscle Training and Respiratory Exercise in Exercise Tolerance, Performing Daily Life Activities and Quality of Life of Patients With COPD.
Study Start Date : January 2011
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inspiratory muscle training group Other: Inspiratory muscle training
A group will be associated with inspiratory muscle training (GTMI). The inspiratory muscle strength training will be done in the POWERbreathe ®, and the patient will breathe for two minutes, seven times with one minute rest between them, with 15% MIP, the first week, then, increased 5-10% to reach 60% of the initial MIP after four weeks. After the first month, every fifteen days the charge will be adjusted to 60% of the new value of MIP. The breathing pattern will remain free

Experimental: Respiratory exercise group Other: Respiratory exercise
Specific exercise program for mobility and biomechanics of the rib cage, as exercises of the trunk and upper limbs, and stretching of large muscle groups of the trunk.





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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the patients with clinical diagnosis of COPD presenting FEV1/FVC < 70% and FEV1 < 80% predicted by pulmonary function observed and were classified as patients with moderate to very severe obstruction (RABE et al., 2008),
  • clinically stable with no history infection or exacerbation of the respiratory symptoms or
  • a change in medication for two months preceding the study.
  • the patients were non oxygen dependent, smokers or former smokers.

Exclusion Criteria:

  • patients with clinical diagnosis of COPD presenting FEV1/FVC ≥ 70% FEV1 ≥ 80% predicted (RABE et al., 2008)
  • who present respiratory, cardiac, rheumatic, musculoskeletal, orthopedic and neuromuscular disorders associated that may prevent them of the testing and intervention proposed,
  • that are experiencing swelling in lower limbs,
  • that change the type of medication during the study,
  • uncontrolled hypertension patients,
  • saturation below 90% at rest and
  • did not agree to sign the formal consent form proposed.

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): NCT01510041


Contacts
Contact: Renata P Basso, Msc 55-169771062 renata.fisio@gmail.com
Contact: Eloisa G Regueiro, Msc 55-1697110381 eloregueiro@yahoo.com.br

Locations
Brazil
Federal University of Sao Carlos Recruiting
Sao Carlos, Sao Paulo, Brazil, 13565-905
Contact: Renata P Basso, Ms    55-169777-1062    renata.fisio@gmail.com   
Contact: Eloisa G Regueiro, Ms    55-1697110381    eloregueiro@yahoo.com.br   
Principal Investigator: Renata P Basso, Ms         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
Principal Investigator: Renata P Basso, Ms Universidade Federal de Sao Carlos

Publications:
Samora GAR, Versiani LC. Diretrizes básicas da fisiologia do exercício para avaliação da capacidade funcional. In: Machado MGR. Bases da fisioterapia respiratória. Terapia intensiva e reabilitação. 1ª Edição, Rio de Janeiro, Guanabara-Koogan, 2008.
Neder JR, Nery LE. Fisiologia Clínica do Exercício. 1ª Edição, São Paulo, Artes Médicas, 2003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renata Pedrolongo Basso, Principal Investigator, Master Degree, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01510041     History of Changes
Other Study ID Numbers: RBV-123-ER
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Renata Pedrolongo Basso, Principal Investigator, Universidade Federal de Sao Carlos:
Chronic obstructive pulmonary disease
Physical therapy
Dyspnea
Inspiratory muscle training
Activities of daily living

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases