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| Name | Class |
|---|---|
| Hospital de Clinicas de Porto Alegre | OTHER |
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This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory muscle metaboreflex through the decrease of calf vascular resistance and increase of calf blood flow in Chronic Obstructive Pulmonary Disease (COPD).
Patients will be selected from the Hospital de Clinicas de Porto Alegre's COPD ambulatory, by convenience. Afterwards, patients will be submitted to pulmonary function test (spirometry) and cardiopulmonary exercise tests (incremental and submaximal), maximal inspiratory pressure evaluation and induction of the inspiratory muscle metaboreflex through venous occlusion plethysmography. Disease specific health related quality of life questionnaire (Saint George Respiratory Questionnaire) and daily life dyspnea questionnaire (Baseline Dyspnea Index and Transitional Dyspnea Index) will be administered at the first and last visit of each subject. Patients will undergo inspiratory muscle training for 30 minutes per day, 7 times a week, for 8 weeks, with Inspiratory Muscle Trainer device (PowerBreath Inc.). There will be a weekly follow up at the institution's Clinical Research Center, where maximal inspiratory pressure (PImax) and inspiratory training techniques will be reevaluated. After this period, tests of pulmonary function, questionnaires exercise tolerance and induction of the inspiratory muscle metaboreflex will be reevaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Patients from the inspiratory muscle training group will utilize a linear pressoric resistance equipment with an inspiratory charge of 30% of maximum inspiratory pressure (adjusted weekly), during 7 days of the week, session duration of 30 minutes, during 8 weeks. |
|
| Sham IMT | Placebo Comparator | Patients in the placebo group will be submitted to inspiratory muscle training with the same equipment as the intervention group, however without a resistance generating spring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training | Other | Patients will receive IMT for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.). During training, patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Inspiratory load was set at 30% of maximal static inspiratory pressure, and weekly training loads were adjusted to maintain 30% of the PImax. Each week, six training sessions were performed at home and one training session was supervised at the hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Calf blood flow | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to exercise tolerance (tlim) | Exercise time during high intensity submaximal Cardiopulmonary exercise testing | 8 weeks |
| Maximum Inspiratory Pressure | 8 weeks |
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Inclusion Criteria:
Selection of subjects will be made through the Hospital de Clinicas de Porto Alegre Pneumology Service's COPD ambulatory. The inclusion criteria consist of -patients with COPD with functional confirmation through spirometry as by previously defined criteria.
Those selected must be classified as GOLD II-IV, with moderate to severe expiratory flow obstruction.
Exclusion Criteria:
Patients will be considered ineligible for this study if they
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| Name | Affiliation | Role |
|---|---|---|
| Danilo C Berton, PhD | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17507545 | Background | 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. | |
| 18678622 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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|
| SHAM | Other | Patients will receive SHAM training for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.) without load. Patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Each week, six training sessions were performed at home and one training session was supervised at the hospital. |
|
| The St George's Respiratory Questionnaire | 8 weeks |
| Baseline Dyspnea Index/Transitional Dyspnea Index | 8 weeks |
| Calf vascular resistance | Calf blood flow/mean arterial pressure | 8 weeks |
| Background |
| Aliverti A, Macklem PT. The major limitation to exercise performance in COPD is inadequate energy supply to the respiratory and locomotor muscles. J Appl Physiol (1985). 2008 Aug;105(2):749-51; discussion 755-7. doi: 10.1152/japplphysiol.90336.2008. Epub 2008 Mar 20. No abstract available. |
| 18678623 | Background | Debigare R, Maltais F. The major limitation to exercise performance in COPD is lower limb muscle dysfunction. J Appl Physiol (1985). 2008 Aug;105(2):751-3; discussion 755-7. doi: 10.1152/japplphysiol.90336.2008a. No abstract available. |
| 18678624 | Background | O'Donnell DE, Webb KA. The major limitation to exercise performance in COPD is dynamic hyperinflation. J Appl Physiol (1985). 2008 Aug;105(2):753-5; discussion 755-7. doi: 10.1152/japplphysiol.90336.2008b. No abstract available. |
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| 16760357 | Background | Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, MacIntyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T; ATS/ERS Pulmonary Rehabilitation Writing Committee. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413. doi: 10.1164/rccm.200508-1211ST. No abstract available. |
| Background | Gayan-Ramirez G, Koulouris N, Roca J, Decramer M. Respiratory and skeletal muscles in chronic obstructive pulmonary disease. Eur Respir Mon 2006; 38: 201-223. |
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| 18492743 | Background | Borghi-Silva A, Oliveira CC, Carrascosa C, Maia J, Berton DC, Queiroga F Jr, Ferreira EM, Almeida DR, Nery LE, Neder JA. Respiratory muscle unloading improves leg muscle oxygenation during exercise in patients with COPD. Thorax. 2008 Oct;63(10):910-5. doi: 10.1136/thx.2007.090167. Epub 2008 May 20. |
| 19299497 | Background | Chiappa GR, Queiroga F Jr, Meda E, Ferreira LF, Diefenthaeler F, Nunes M, Vaz MA, Machado MC, Nery LE, Neder JA. Heliox improves oxygen delivery and utilization during dynamic exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Jun 1;179(11):1004-10. doi: 10.1164/rccm.200811-1793OC. Epub 2009 Mar 19. |
| 20627914 | Background | Berton DC, Barbosa PB, Takara LS, Chiappa GR, Siqueira AC, Bravo DM, Ferreira LF, Neder JA. Bronchodilators accelerate the dynamics of muscle O2 delivery and utilisation during exercise in COPD. Thorax. 2010 Jul;65(7):588-93. doi: 10.1136/thx.2009.120857. |
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| 10588589 | Background | O'Donnell DE, D'Arsigny C, Raj S, Abdollah H, Webb KA. Ventilatory assistance improves exercise endurance in stable congestive heart failure. Am J Respir Crit Care Med. 1999 Dec;160(6):1804-11. doi: 10.1164/ajrccm.160.6.9808134. |
| 18436118 | Background | Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045. |
| 16973699 | Background | McConnell AK, Lomax M. The influence of inspiratory muscle work history and specific inspiratory muscle training upon human limb muscle fatigue. J Physiol. 2006 Nov 15;577(Pt 1):445-57. doi: 10.1113/jphysiol.2006.117614. Epub 2006 Sep 14. |
| 17855758 | Background | Witt JD, Guenette JA, Rupert JL, McKenzie DC, Sheel AW. Inspiratory muscle training attenuates the human respiratory muscle metaboreflex. J Physiol. 2007 Nov 1;584(Pt 3):1019-28. doi: 10.1113/jphysiol.2007.140855. Epub 2007 Sep 13. |
| 15235292 | Background | Troosters T, Gosselink R, Decramer M. Chronic obstructive pulmonary disease and chronic heart failure: two muscle diseases? J Cardiopulm Rehabil. 2004 May-Jun;24(3):137-45. doi: 10.1097/00008483-200405000-00001. |
| 18035433 | Background | Muthumala A. Chronic heart failure and chronic obstructive pulmonary disease: one problem, one solution? Int J Cardiol. 2008 Mar 28;125(1):1-3. doi: 10.1016/j.ijcard.2007.07.160. Epub 2007 Nov 26. |
| 21282809 | Background | Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810. |
| 16487841 | Background | Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26. |
| 16055882 | Background | Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available. |
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| 11633911 | Background | Orsted HC, Baerentsen K, Jensen VG, Kofod H, Thorn NA, Trolle D. [On the origin and benefits of amniotic fluid. [Reprint of 1797 edition]. Published with comments and notes by the Danish society of the history of pharmacy. With historical contributions by K. Baerentsen, V. G. Jensen, H. Kofod, N. A. Thorn, D. Trolle]. Theriaca. 1977;18:1-107. No abstract available. Danish. |
| 10412549 | Background | Neder JA, Andreoni S, Castelo-Filho A, Nery LE. Reference values for lung function tests. I. Static volumes. Braz J Med Biol Res. 1999 Jun;32(6):703-17. doi: 10.1590/s0100-879x1999000600006. |
| 10412551 | Background | Neder JA, Andreoni S, Peres C, Nery LE. Reference values for lung function tests. III. Carbon monoxide diffusing capacity (transfer factor). Braz J Med Biol Res. 1999 Jun;32(6):729-37. doi: 10.1590/s0100-879x1999000600008. |
| 10412550 | Background | Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |