Effects of Pulmonary Rehabilitation on Respiratory, and Cardiovascular Functional Capacity in COPD

NCT02393469 | Unknown

• 1 other identifier: RP_01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The Chronic Obstructive Pulmonary Disease (COPD) has shown a progressive increase of morbidity and mortality, suggesting that the lung as a single therapeutic target, has not contributed in the past 20 years, significant changes to the natural evolution of the disease. Direct treatment for systemic changes and comorbidities, in fact, the most responsible for high rates of treatment failure could mean a new hope of life for individuals with COPD. This research project characterized as interdisciplinary and multidisciplinary program will be headquartered in Pulmonary Rehabilitation of the Santa Cruz Hospital which has partnerships with local companies . Its main objective will be to analyze cardiorespiratory and functional capacity in COPD patients not rehabilitated and rehabilitated after the period from 02 to 12 months of treatment in a Pulmonary Rehabilitation program in the municipality of Santa Cruz do Sul - Rio Grande do Sul. Will be included in this survey of COPD patients who were referred to a rehabilitation program with a clinical diagnosis of disease. In research activities to assess cardiorespiratory and functional capacity of COPD, pre and post-program (02 and 12 months) are provided for Pulmonary Rehabilitation. The research subjects will also be subjected to physical exercise protocol as recommended by the GOLD (2009), a period of eight weeks, often 2x / week, where their vital signs are measured before, during and after each session. Thus, it is believed that it will be possible to refine the knowledge of mechanisms by which the judicious use of pulmonary rehabilitation can control the progression of COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Functional capacity in COPD patients

  Will initially be evaluated after ten months.

Secondary Outcomes (12)

• Ankle brachial index

  Will be assessed after the admission of patients to pulmonary rehabilitation program. will be held after admission, subsequently after two and ten months

• Window in ischemic lower limbs

  will be evaluated after functional testing submaximal. will be held after admission, subsequently after two and ten months

• walk test six minutes

  will be conducted to evaluate rates of ischemic window by ankle brachial index, will be held after admission, subsequently after two and ten months

• heart rate variability

  will be held Durantes three tests: Shuttle Walk Test, test and six-minute walk incremental protocol in cycle rgometer. will be held after admission, subsequently after two and ten months

• Shuttle Walk Test

  Will be conducted to evaluate the functional capacity of the study participants. will be held after admission, subsequently after two and ten months

Study Arms (3)

Group phase 1

PLACEBO COMPARATOR

Two months of education and self-management for COPD where patients know their disease, pathophysiology, treatment, exacerbation of symptoms, and better ways pharmacological treatment education will be conducted through a system of multidisciplinary lessons with professional Physiotherapists, Psychologists, Dieticians, Pharmacists , Physical Education Professionals and Doctors

Other: Education and self-management for COPD

Group phase 2

EXPERIMENTAL

Pulmonary rehabilitation for two months: The same patients enter phase 1 phase 2 performing this two months of pulmonary rehabilitation are also included new patients who participate directly in phase 2

Other: pulmonary rehabilitation

Group phase 3

EXPERIMENTAL

Pulmonary rehabilitation for ten months: Participate participants of phases 1 + 2 and 2, as well as new participants enter directly in phase 3

Other: pulmonary rehabilitation

Interventions

pulmonary rehabilitation OTHER

Exercises breathing exercises are performed on a cycle ergometer for 30 minutes, monitored by 50% of your maximum heart frequency, strengthening exercises for major muscle groups of the upper and lower limbs with charges based on 70% of one repetition maximum, muscle stretching test, and in expiratory pattern

Group phase 2; Group phase 3

Education and self-management for COPD OTHER

Two months of continuous and self management for COPD where patients know their disease, pathophysiology, treatment, exacerbation of symptoms, and better ways pharmacological treatment education will be conducted through a system of multidisciplinary lessons with professional Physiotherapists, Psychologists, Dieticians, Pharmacists , Physical Education Professionals and Doctors

Group phase 1

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD patients with a clinical diagnosis

You may not qualify if:

• Motor sequelae of stroke, patients undergoing treatment for infectious diseases, musculoskeletal disorders that impede ambulation

Sponsors & Collaborators

• University of Santa Cruz do Sul: lead

Study Sites (1)

Universidade de Santa Cruz do Sul

Santa Cruz do Sul, Rio Grande do Sul, 96815-900, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status; Self-Management

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)

Socioeconomic Factors; Population Characteristics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andrea L Gonçalves da Silva, Doctor

  University of Santa Cruz do Sul

  PRINCIPAL INVESTIGATOR

• Dulciane N Paiva, Doctor

  University of Santa Cruz do Sul

  STUDY DIRECTOR

• Dannuey M Cardoso, Ms

  University of Santa Cruz do Sul

  STUDY CHAIR

• Diogo F Bordin, Academic

  University of Santa Cruz do Sul

  STUDY CHAIR

• Ricardo Gass, Academic

  University of Santa Cruz do Sul

  STUDY CHAIR

• Cássia L Goulart, Academic

  University of Santa Cruz do Sul

  STUDY CHAIR

• Natacha Angélica M da Fonseca, Academic

  University of Santa Cruz do Sul

  STUDY CHAIR

• Camila da C Niedermeyer, Academic

  University of Santa Cruz do Sul

  STUDY CHAIR

• Lisiane L Carvalho, Msc

  University of Santa Cruz do Sul

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: March 19, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

BR (1)