Effects of Pulmonary Rehabilitation on Function Cardiovascular, Respiratory and Functional Capacity of People With Chronic Obstructive Pulmonary Disease in the Municipality of Santa Cruz do Sul - Rio Grande do Sul.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Functional capacity in COPD patients
研究概览
简要总结
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.
详细描述
Selection of project participants
COPD, duly diagnosed with proof of spirometric lung function, who are receiving outpatient care at the Hospital Santa Cruz (HSC) to compose the control group will be selected. For Rehabilitation Pulmonary Group fase 01 (GRP1) and Rehabilitation Pulmonary Group fase 02 (GRP2) will be selected COPD patients who participate in the program Rehabilitation Pulmonary occurring within the HSC, in the municipality of Santa Cruz do Sul - Rio Grande do Sul. The sample size calculation is performed according to the primary endpoint of the study.
All individuals involved in the project have signed a term of informed consent and answer a questionnaire of personal health, containing demographic information, exposure to radiation and drugs, as well as eating habits and consumption of alcohol and cigarettes.
Methodological procedures
The methodological steps of the study will consist of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD patients with a clinical diagnosis
排除标准
- •Motor sequelae of stroke, patients undergoing treatment for infectious diseases, musculoskeletal disorders that impede ambulation
研究组 & 干预措施
Group phase 2
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
干预措施: pulmonary rehabilitation (Other)
Group phase 3
Pulmonary rehabilitation for ten months: Participate participants of phases 1 + 2 and 2, as well as new participants enter directly in phase 3
干预措施: pulmonary rehabilitation (Other)
Group phase 1
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
干预措施: Education and self-management for COPD (Other)
结局指标
主要结局
Functional capacity in COPD patients
时间窗: Will initially be evaluated after ten months.
次要结局
- 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)
- Window in ischemic lower limbs(will be evaluated after functional testing submaximal. will be held after admission, subsequently after two and ten months)
- assessment of lung function(will be held after the admission of patients to the project, will be held after admission, subsequently after two and ten months)
- assessment of the economic and social level(will be evaluated only once)
- classification of patients as BODE index(Will be assessed at baseline (start of pulmonary rehabilitation) and after 10 months (final evaluation))
- 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)
- assessment of quality of life(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)
- assessment of respiratory muscle strength(will be held after admission, subsequently after two and ten months)
- assessment of handgrip strength(will be held after admission, subsequently after two and ten months)
- Incremental protocol in cycle ergometer (Astrand Treadmill test)(will be held in conjunction with analysis of the lactate curve to assess the ability of resistance to fatigue of the participants, will be held after admission, subsequently after two and ten months)
研究者
Andrea Lucia Gonçalves da Silva
Doctor
University of Santa Cruz do Sul