跳至主要内容
临床试验/NCT05632120
NCT05632120Enrolling By Invitation不适用

Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions According to the ICF Framework in Chronic Obstructive Pulmonary Diseases

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
Activities-Specific Balance Confidence scale

研究概览

简要总结

This cross-sectional study aims to investigate to the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in Chronic Obstructive Pulmonary Diseases (COPD) patients.

详细描述

To investigate the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in patients with COPD, fifty patients with COPD will be included.

The Modified Medical Research Council Dyspnea (MMRC) scale and Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. Isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. The level of dyspnea during daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale. The global impacts of COPD symptoms on overall health status will be evaluated by The COPD Assessment Test (CAT). Pulmonary function data will be retrieved from the last 1-month clinical records of the COPD patients. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 21.0. Descriptive statistics of continuous variables will be presented with mean, standard deviation (SD), confidence interval (CI) values, and descriptive statistics of categorical variables will be presented with frequency and percentage values. The conformity of the data to the normal distribution will be evaluated with the "Shapiro Wilk Test". According to the results of the analysis, "Pearson correlation test" or "Spearman correlation test" will be used to determine the relationship between dependent variables. The significance level will be set as p<0.05.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stable disease (no severe exacerbations in the prior 3 months)
  • ability to walk independently
  • ability to read and write in Turkish
  • able to follow simple instructions
  • no pathology in visual ability and hearing

排除标准

  • a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder)
  • severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
  • use of medication(s) that may increase the risk of falls
  • participate in pulmonary rehabilitation in the lasts six months

结局指标

主要结局

Activities-Specific Balance Confidence scale

时间窗: Baseline

Activities-Specific Balance Confidence (ABC) scale will be used for evaluating the confidence in maintaining the balance in activities daily living. It provides information on the level of concern about falls during16 community-based and home-based activities. Scale scores between 0 (unsafe) to 100 (completely safe) and the total score (0-1600) is divided by 16 to obtain an individual's ABC score, with higher scores indicating greater balance confidence. In patients with COPD, the ABC scale has demonstrated construct validity as well as criterion validity for falls. In addition, the participants will be also questioned concerning the occurrence of falls and the risk of falling during the activity in each item of the ABC scale.

次要结局

  • London Chest Activity of Daily Living scale(Baseline)
  • The COPD Assessment Test(Baseline)
  • The strength of quadriceps femoris(Baseline)
  • The Modified Medical Research Council Dyspnea scale(Baseline)
  • Six-Minute Walking Test (6MWT)(Baseline)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tansu Birinci

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (1)

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