Rehabilitation Cardiorrespiratory Improvement in Patients With Chronic Disease Obstructive Pulmonary

NCT02783326 | Completed DMC

• 1 other identifier: 1322578
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Disease Obstructive Pulmonary

Keywords

Chronic Disease Obstructive Pulmonary; Rehabilitation; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Heart rate variability modulation

  Heart rate variability evaluation

  Change from baseline autonomic modulation at 2 months

Study Arms (2)

COPD Group

EXPERIMENTAL

Evaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application

Other: Rehabilitation

Control Group

ACTIVE COMPARATOR

Evaluation of oxidative stress, heart rate variability, quality of life with AQ20 questionary, function with TC6 before the application of rehabilitation protocol, after 10 weeks during protocol application and 2 months after protocol application

Other: Rehabilitation

Interventions

Rehabilitation OTHER

Pulmonary rehabilitation, exercise in COPD individuals and health individuals

COPD Group; Control Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• to 70 years of age
• hemodynamically stable

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead

Study Sites (1)

Hospital João de Barros Barretos

Belém, Pará, 66073-000, Brazil

Location

Related Publications (5)

• Borghi-Silva A, Arena R, Castello V, Simoes 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.

  PMID: 19464865 RESULT

• 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.

  PMID: 21857781 RESULT

• 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.

  PMID: 19342436 RESULT

• 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. doi: 10.1590/s1806-37132009000100004. English, Portuguese.

  PMID: 19219327 RESULT

• 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(1):7. doi: 10.1186/1465-9921-8-7.

  PMID: 17261190 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rodrigo S Rocha, Master

  Universidade Metodista de Piracicaba

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: May 26, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)