Chronic Disease Obstructive Pulmonary Clinical Trial
Official title:
Effects of a Protocol Of Rehabilitation in Patients With Chronic Disease Obstructive Pulmonary (COPD) Improvement Modulation Autonomic Heart Rate, Oxidative Stress, Quality of Life and Function
NCT number | NCT02783326 |
Other study ID # | 1322578 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | June 2017 |
Verified date | November 2018 |
Source | Universidade Metodista de Piracicaba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic obstructive pulmonary disease (COPD) is a condition in which the lung is in chronic state due to an inflammatory response that leads to limitation in lung function of the individual, providing symptoms such as dyspnea, nutritional changes, decreased strength respiratory muscle, low capacity to exercise, dynamic insufflation and altered autonomic function with decreased heart rate variability. Have objective to evaluate and compare the effects of a rehabilitation protocol on autonomic modulation of heart rate. Participate in the study, 10 volunteers with COPD and 10 apparently healthy individuals, of both sexes, between 50 and 70 years old. Data collection and application of the Protocol will take place at the Clinical School of Physiotherapy and Occupational Therapy at the University of the Amazon (UNAMA). Between January and February 2015.
Status | Completed |
Enrollment | 26 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: - individuals who have been diagnosed with COPD , stage II and III disease - are undergoing treatment at the hospital João de Barros Barreto in the period January and February 2016 - both sexes - 50 to 70 years of age - hemodynamically stable Exclusion Criteria: - were not diagnosed with COPD - present associated diseases that may interfere with cardiac autonomic control, - had less than 50 years or over 70 years old - are in stage I of the COPD - in intensive care unit - present muscle skeletal deformities - hemodynamic instability - make use of pacemakers - in need of supplemental O2 - who do not tolerate the practice of exercises |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital João de Barros Barretos | Belém | Pará |
Lead Sponsor | Collaborator |
---|---|
Universidade Metodista de Piracicaba |
Brazil,
Borghi-Silva A, Arena R, Castello V, Simões RP, Martins LE, Catai AM, Costa D. Aerobic exercise training improves autonomic nervous control in patients with COPD. Respir Med. 2009 Oct;103(10):1503-10. doi: 10.1016/j.rmed.2009.04.015. Epub 2009 May 22. — View Citation
Decramer M. Response of the respiratory muscles to rehabilitation in COPD. J Appl Physiol (1985). 2009 Sep;107(3):971-6. doi: 10.1152/japplphysiol.91459.2008. Epub 2009 Apr 2. Review. — View Citation
Eisner MD, Blanc PD, Sidney S, Yelin EH, Lathon PV, Katz PP, Tolstykh I, Ackerson L, Iribarren C. Body composition and functional limitation in COPD. Respir Res. 2007 Jan 29;8:7. — View Citation
Fischer BM, Pavlisko E, Voynow JA. Pathogenic triad in COPD: oxidative stress, protease-antiprotease imbalance, and inflammation. Int J Chron Obstruct Pulmon Dis. 2011;6:413-21. doi: 10.2147/COPD.S10770. Epub 2011 Aug 5. Review. — View Citation
Pelegrino NR, Lucheta PA, Sanchez FF, Faganello MM, Ferrari R, Godoy Id. Influence of lean body mass on cardiopulmonary repercussions during the six-minute walk test in patients with COPD. J Bras Pneumol. 2009 Jan;35(1):20-6. English, Portuguese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rate variability modulation | Heart rate variability evaluation | Change from baseline autonomic modulation at 2 months |