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临床试验/NCT03386604
NCT03386604已完成不适用

Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease in Pulmonary Rehabilitation With and Without Supplementation of Whey

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Physical capacity through the maximum distance traveled

研究概览

简要总结

Chronic obstructive pulmonary disease is characterized by obstruction to pulmonary airflow and dyspnea. These characteristics are a consequence of exposure to harmful gases and particles that lead to oxidative stress in the lungs together with an exaggerated inflammatory response. In addition to respiratory impairment, chronic obstructive pulmonary disease has systemic manifestations, nutritional alterations, and exercise limitation. Pulmonary rehabilitation is one of the most effective interventions in the treatment of chronic obstructive pulmonary disease, with one goal being to improve patient capacity. Whey protein supplementation, concomitant with physical activity for patients with chronic obstructive pulmonary disease, aims to stimulate protein synthesis and decrease muscle catabolism that may be caused by exercise. The investigators aimed to evaluate the effects of whey protein supplementation supplementation on the physical capacity, body composition and tissue functionality of patients with chronic obstructive pulmonary disease in a pulmonary rehabilitation program.

详细描述

A randomized clinical study will be carried out with 62 patients (31 patients per group) with chronic obstructive pulmonary disease who came from specialized departments of the Pulmonology Service of the Hospital de Clínicas of Porto Alegre and were referred to the pulmonary rehabilitation program of this institution. Patients will be evaluated in relation to anthropometry, body composition, blood biochemistry, phase angle, dietary intake, physical capacity, muscle strength and lung function. The data will be processed in the statistical program SPSS version 17.0 and for statistical analysis they will be tested for their normality by the Kolmogorov-Smirnoff test and after this definition will be applied specific tests for parametric or non-parametric data, being they presented in the form of mean and standard deviation or median, minimum and maximum, according to their distribution. The differences will be considered significant for values of p <0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have been referred for pulmonary rehabilitation for chronic obstructive pulmonary disease diagnosis;
  • Stable for the last 3 months and have no contraindications to exercise (no infection, acute myocardial infarction, malignant neoplasms, renal or hepatic disease, ascites / edema or neuromuscular disease);
  • Be 40 years or older;
  • Being literate;

排除标准

  • Being a vegetarian;
  • Make use of continuous oxygen;
  • Present cognitive or functional changes that limit the execution of any of the proposed tests.
  • Body mass index <21.0 kg / m² and ≥ 35.0 kg / m².

结局指标

主要结局

Physical capacity through the maximum distance traveled

时间窗: 8 weeks

The test will be performed during 6 minutes on a previously measured surface with a distance of 30m, without additional oxygen support.

次要结局

  • Body composition (amount of muscle mass) wiht absorptiometry by dual emission of X-ray(8 weeks)
  • Tissue functionality through phase angle(8 weeks)
  • Muscle strength through manual grip strength of dominant and non-dominant limbs(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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