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

NCT01510041 | Unknown DMC

• 1 other identifier: RBV-123-ER
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Physical therapy; Dyspnea; Inspiratory muscle training; Activities of daily living

Study Arms (2)

Inspiratory muscle training group

EXPERIMENTAL

Other: Inspiratory muscle training

Respiratory exercise group

EXPERIMENTAL

Other: Respiratory exercise

Interventions

Inspiratory muscle training OTHER

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

Inspiratory muscle training group

Respiratory exercise OTHER

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.

Respiratory exercise group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Federal University of Sao Carlos

São Carlos, São Paulo, 13565-905, Brazil

RECRUITING

Related Publications (10)

• Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

  PMID: 17507545 BACKGROUND

• Fiz JA, Romero P, Gomez R, Hernandez MC, Ruiz J, Izquierdo J, Coll R, Morera J. Indices of respiratory muscle endurance in healthy subjects. Respiration. 1998;65(1):21-7. doi: 10.1159/000029223.

  PMID: 9523364 BACKGROUND

• Ramirez-Sarmiento A, Orozco-Levi M, Guell R, Barreiro E, Hernandez N, Mota S, Sangenis M, Broquetas JM, Casan P, Gea J. Inspiratory muscle training in patients with chronic obstructive pulmonary disease: structural adaptation and physiologic outcomes. Am J Respir Crit Care Med. 2002 Dec 1;166(11):1491-7. doi: 10.1164/rccm.200202-075OC. Epub 2002 Jul 19.

  PMID: 12406842 BACKGROUND

• 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.

  BACKGROUND

• Clarenbach CF, Senn O, Brack T, Kohler M, Bloch KE. Monitoring of ventilation during exercise by a portable respiratory inductive plethysmograph. Chest. 2005 Sep;128(3):1282-90. doi: 10.1378/chest.128.3.1282.

  PMID: 16162719 BACKGROUND

• Parreira VF, Tomich GM, Britto RR, Sampaio RF. Assessment of tidal volume and thoracoabdominal motion using volume and flow-oriented incentive spirometers in healthy subjects. Braz J Med Biol Res. 2005 Jul;38(7):1105-12. doi: 10.1590/s0100-879x2005000700014. Epub 2005 Jul 4.

  PMID: 16007282 BACKGROUND

• Hill K, Jenkins SC, Philippe DL, Shepherd KL, Hillman DR, Eastwood PR. Comparison of incremental and constant load tests of inspiratory muscle endurance in COPD. Eur Respir J. 2007 Sep;30(3):479-86. doi: 10.1183/09031936.00095406. Epub 2007 May 15.

  PMID: 17504795 BACKGROUND

• Neder JR, Nery LE. Fisiologia Clínica do Exercício. 1ª Edição, São Paulo, Artes Médicas, 2003.

  BACKGROUND

• Sociedade Brasileira de Cardiologia. [Standardization of techniques and devices for ergometric and ergospirometric exams]. Arq Bras Cardiol. 2003 Apr;80(4):457-64. Epub 2003 Apr 29. No abstract available. Portuguese.

  PMID: 12754567 BACKGROUND

• Basso-Vanelli RP, Di Lorenzo VA, Labadessa IG, Regueiro EM, Jamami M, Gomes EL, Costa D. Effects of Inspiratory Muscle Training and Calisthenics-and-Breathing Exercises in COPD With and Without Respiratory Muscle Weakness. Respir Care. 2016 Jan;61(1):50-60. doi: 10.4187/respcare.03947. Epub 2015 Nov 10.

  PMID: 26556894 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Renata P Basso, Ms

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renata P Basso, Msc

CONTACT

55-169771062; renata.fisio@gmail.com

Eloisa G Regueiro, Msc

CONTACT

55-1697110381; eloregueiro@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 13, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2013
• Last Updated: January 13, 2012

Record last verified: 2012-01

Locations

BR (1)