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临床试验/NCT04076085
NCT04076085Unknown不适用

Effect of Unsupported Upper Extremity Exercise Versus Lower Extremity Exercise in Individuals With Chronic Obstructive Disease (COPD) on Dyspnea and Peak Flow Rate

King Khalid University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Airway Questionnaire 20

研究概览

简要总结

Objective: is to find out the effect of unsupported upper extremity exercise versus lower extremity exercise on dyspnea and lung function

Methodology:

Sample and design: 60 patients with Randomized study design will be included in three groups.

Duration of intervention: Treatment will continue for 4 weeks. Outcome: Borgs scale and Medical Research Council scale (MRC) for dyspnea will be used to quantify the dyspnea. Lung function tests measure by PEFR, chronic obstructive pulmonary disease assessment test (CAT) will be used pre-post.

Discussion: We will compare three groups (UPPER EXTREMITY EXCERCISE (UEx), LOWER EXTREMITY EXERCISE (LEx), CONTROL (CON)) with COPD using interventional exercises for upper and lower extremities randomly assigned to three groups on the dyspnea symptoms and quantify and grade them pre-post the intervention. We will also use the CAT questionnaire pre-post to measure the changes in symptoms and functions.

详细描述

Background: Chronic Obstructive Pulmonary Disease (COPD) is one of the most common respiratory disorder affecting middle age group with progressing of symptoms worsening over time. The respiratory symptoms are persistent with compromised airflow due to small airway disorders or parenchymal abnormalities. The morbidity rate of COPD is about 251 million cases and mortality of 3.17 million per year globally with expected inflation in the future. The disease and death rate are well associated with dysfunction of skeletal muscle and cachexia. The amount of reduction in muscle strength of limbs is directly proportional to the severity of the disease. Dyspnea and decrement in endurance capacity will negatively affect the functional capability and quality of life in people suffering from COPD. Unsupported upper limb endurance training and lower limb endurance training showed significant improvement in Six-minute walk test and Quality of life.

Purpose: To determine the effect of Unsupported upper extremity endurance training and Unsupported lower extremity endurance training on dyspnea, lung function and quality of life.

Methodology: Study design: Randomized study design Study population: The people suffering from COPD referred by pulmonologist will be contacted for consent after oral explanation and answering all questions. After all the informed consents had been collected, randomization will be performed. The participants are randomly allocated to the Unsupported upper extremity endurance training (Experimental group-1), Unsupported lower extremity endurance training (Experimental group-2) and Conventional (Control group) prior to the first baseline assessment. The intensity of Exercise will be checked by the Original Borgs scale and Medical Research Council scale (MRC) for dyspnea.

Outcome measures: Lung function tests measures using PEFR, Airway Questionnaire 20 pre-post to measure the changes in symptoms and functions

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)

盲法说明

An employee outside the research team will feed data into the computer in separate datasheets so that the researchers can analyze data without having access to information about the allocation

入排标准

年龄范围
10 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed cases of COPD
  • COPD secondary to any disease
  • Age 10-70 years
  • COPD in any stage according to GOLD classification

排除标准

  • Taking any other form of alternative therapies
  • The neurological deficit with the inability to understand of following instructions
  • Recent Cardiovascular surgery patients
  • Unstable angina patients
  • Patients with musculoskeletal deficits

结局指标

主要结局

Airway Questionnaire 20

时间窗: Change is being evaluated from Baseline and at 4 wk

The Airway Questionnaire 20 (AQ20) was developed for patients with asthma and chronic obstructive pulmonary disease (COPD). It contains 20 items, with scores ranging from 0 to 20 - high scores indicate poor QOL. It takes only a few minutes to complete and has been validated in asthma and COPD patients.

Borg's scale and Medical Research Council scale (MRC) for dyspnea

时间窗: Change is being evaluated from Baseline and at 4 wk

The Borg Rating of Perceived Exertion (RPE) scale will help you estimate how hard you're working (your activity intensity). Perceived exertion is how hard you think your body is exercising. Ratings on this scale are related to heart rate (how hard your heart is working to move blood through your body). Scale Range 6-20. Medical Research Council Scale of Breathlessness : The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). It can be self-administered by asking subjects to choose a phrase that best describes their condition, e.g. 'I only get breathless with strenuous exertion' (Grade 1) or 'I am too breathless to leave the house' (Grade 5).

次要结局

  • Peak Expiratory Flow Rates (PEFR)(Change is being evaluated from Baseline and at 4 wk)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Snehil Dixit

Assistant Professor , Department of Medical Rehabilitation

King Khalid University

研究点 (1)

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