跳至主要内容
临床试验/NCT05986448
NCT05986448已完成不适用

Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and Malnutrition: a Multicenter Randomized Controlled Trial

Houmei SHEN1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
BODE index

研究概览

简要总结

The goal of this clinical trial is to learn about the therapeutic effect of Chinese traditional exercise Tai Chi in elderly acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with malnutrition. The main questions it aims to answer are:

  1. Improvement of pulmonary function in patients with Tai Chi exercise;
  2. Improvement of pulmonary function in patients with Tai Chi exercise.

The patients in control group were given routine nursing care model, including:

  1. Providing basic nursing care and protection for patients according to their needs, paying attention to the care of patients' airways, and providing relevant protection and auxiliary interventions according to the needs of patients when carrying out nebulized inhalation interventions;
  2. Customized nutritional supplementation recipes by specialists in clinical nutrition, giving high-protein and low-carbohydrate diets, and giving enteral or parenteral nutritional support to those who have insufficient food intake through the mouth;
  3. Carrying out health education and psychological care to alleviate the patients' psychological burdens.

On the basis of the routine care model of the control group, a Tai Chi training program was developed in Tai Chi group. Tai Chi training lasted for a total of 6 months, with 4 training sessions scheduled per week, each session lasting about 40 minutes. Experts from Anqing Tai Chi Association were invited to guide the training. The training program consists of a 5-minute pre-training warm-up, a 30-minute Tai Chi exercise, and a 5-minute post-training stretching session. The Tai Chi training was done at a moderate intensity, with the heart rate limited to 60%~80% of the maximal heart rate, where:

maximal heart rate=220-age. Accelerometers were worn for each member to record heart rate changes during training, and when the heart rate exceeded the standard range, the exercise intensity could be adjusted to keep the heart rate within a reasonable range.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥60 and ≤85 years of age;
  • Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria;
  • Patients admitted to the hospital for treatment of chronic, repetitive coughing and severe dyspnea;
  • NRS-2002 Nutritional Risk Screening Scale score ≧3, suggesting malnutrition;
  • Conscious, able to perform normal verbal communication and without motor dysfunction

排除标准

  • People with impaired consciousness or invasive mechanical ventilation who were unable to fully understand and cooperate with the experiment;
  • People with active tuberculosis, lung cancer, asthma and other diseases limiting ventilation;
  • People with impaired motor function;
  • People with serious life-threatening diseases of other systems and malignant tumors;
  • People with heart failure (NYHA stage IV).

结局指标

主要结局

BODE index

时间窗: Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.

Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)

Plasma total protein

时间窗: Measurements of plasma total protein will be taken prior to the start of the trial and at 6 months after the start of the trial.

次要结局

  • Plasma albumin(Measurements of plasma albumin will be taken prior to the start of the trial and at 6 months after the start of the trial.)
  • Plasma prealbumin(Measurements of plasma prealbumin will be taken prior to the start of the trial and at 6 months after the start of the trial.)

研究者

发起方
Houmei SHEN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Houmei SHEN

Senior nursing officer, Department of Emergency Medicine, Anqing Hospital Affiliated to Anhui Medical University, China

Anhui Medical University

研究点 (1)

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