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临床试验/NCT04841005
NCT04841005已完成不适用

Investigation of the Effect of Square-Step Exercise Applied by Telerehabilitation on Cognitive Functions, Balance and Quality of Life in COPD Patients

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Measurement of change in postural stability

研究概览

简要总结

COPD is a progressive disease associated with systemic inflammation, with many extrapulmonary outcomes such as cognitive impairment. Most of the daily activities involve doing several tasks at the same time, such as walking while talking or avoiding obstacles.

详细描述

The most prominent independent risk factor for cognitive impairment in COPD patients is reduced oxygen availability as a result of lung dysfunction. The prevalence of cognitive impairment in COPD patients ranges from 10% to 61%. A wide variety of tools have been developed for screening cognitive functions. The most widely used tests covering multiple cognitive domains are the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA).

When two tasks are performed at the same time, they compete for sources of attention, resulting in decreased performance on one or two tasks. Balance or postural control is a complex skill required for independent mobility and preventing falls. Balance performance naturally decreases with age; however, certain conditions are associated with more pronounced and rapid declines. Balance problems and fall risk are increased in COPD patients.From this perspective aim of this study is to assess the effect of square-step exercise and strengthening exercise applied with telerehabilitation on cognitive status and balance in patients with COPD.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • •Being diagnosed with mild / moderate COPD by Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Chest Diseases.
  • •Mini mental score is 23 or higher
  • •Being between the ages of 50-80
  • •Spirometric evaluation result is forced expiratory volume at one second / Forced vital capacity <70% and airflow restriction is 50% forced expiratory volume at one second <80% (expected) degree compared to post-bronchodilator forced expiratory volume at one second.
  • •No drug change or antibiotic use due to acute exacerbation for at least three weeks

排除标准

  • •Individuals who need continuous oxygen support
  • •Individuals with partial pressure of carbon dioxide≥70 mmHg
  • •Having a history of uncontrolled illness that may affect cognitive skills
  • •Have uncorrected vision and hearing impairment
  • •Having kyphoscoliosis and/or severe postural impairment
  • •Having additional risk factors (stroke, neurological disease, dementia, depression, postural hypotension, diaphragm dysfunction)

研究组 & 干预措施

Square-Step Exercise group

Experimental

Square-step exercise for 8 weeks will be applied under the supervision of a physiotherapist.

干预措施: The Square-Step Exercise Training (Other)

Strengthening Exercise Group

Experimental

Strengthening exercise for 8 weeks will be applied under the supervision of a physiotherapist.

干预措施: Strengthening Exercise Training (Other)

结局指标

主要结局

Measurement of change in postural stability

时间窗: Two measurements: At the beginning and after eight weeks

Postural stability is assessed using the Biodex Balance System. It consists of a mobile platform with 20 degrees of inclination in all directions and 12 levels of difficulty. With this system, balance is evaluated thanks to circular platforms that can oscillate simultaneously in the general, front-rear and left-right axes. The right-left stability indices are derived from the platform angular displacement in the frontal plane, while the anteroposterior angular displacement represents the platform displacement in the sagittal plane.

Change of the point in the cognitive test

时间窗: Two measurements: At the beginning and after eight weeks

Montreal Cognitive Assessment will be used to evaluate cognitive impairment. The application time of the single-page scale is approximately 10 minutes and includes 6 cognitive functions.Cognitive functions evaluated in the scale are as follows: 1. Memory 2. Visual-spatial skills 3. Executive functions, 4. Attention, concentration and working memory tasks, 5. Language, 6. Orientation. The lowest score that can be obtained from the scale is 0, the highest score is 30.

Measuring change in quality of life

时间窗: Two measurements: At the beginning and after eight weeks

St George's Respiratory Questionnaire (SGRQ) has been the most widely used quality of life measurement designed to evaluate the quality of life in lung diseases. SGRQ has distinctive (able to distinguish between different severity levels between patients) and descriptive (can detect disease progression and changes with treatment). The score range ranges from 0 (excellent health) to 100 (most severe disease) and the minimum clinically significant change is considered to be 4 units. This survey has good reproducibility in the short term. It consists of 50 questions in total. The numerical evaluation of the questionnaire is calculated in 4 separate sections as symptom score, activity score, impact score and total score.

Measurement of change in functional balance

时间窗: Two measurements: At the beginning and after eight weeks

The Balance Evaluation Systems Test (BESTest) will be used to evaluate functional balance. BESTest examines the balance in 6 sections in order to reveal whether the special balance control systems, which are defined as biomechanical structures, stability limits / verticality, intuitive postural adjustments, postural responses, sensory orientation and walking stability, function adequately. Since some of the tasks of BESTest have two subtitles, right side and left side, the patient is evaluated under 36 titles in total. In a sequential scale where each title is scored at 4 levels, 0 represents the worst performance, 3: the best performance. The total score of the test, which has a maximum of 108 points, can be calculated separately by calculating the percentage at the end of each section, as well as calculating the percentage of the total score.

Hospital Anxiety and Depression Scale

时间窗: At the enrollment process

It was developed to screen mood disorders in groups with a medical illness. It is a scale filled by the patient. It consists of 14 items. Substances contain 4 properties. Depression and anxiety are tried to be evaluated with the help of two subscales. The 7-item depression subscale has a scoring system between 0 and 21. The threshold value indicates "Normal" between 0-7, "Mild" between 8-10, "Moderate" between 11-14, "Severe" between 15-21.

次要结局

  • Assessment of comorbidities(At the enrollment process)
  • 1 Minute Sit and Stand Test(Two measurements: At the beginning and after eight weeks)
  • Evaluation of shortness of breath(At the enrollment process)
  • Forced vital capacity(At the enrollment process)
  • Forced expiratory volume in the first second(At the enrollment process)
  • Assessment of the COPD(At the enrollment process)
  • Mini mental test(At the enrollment process)
  • The ratio of FEV1 to FVC(At the enrollment process)

研究者

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

Alp Ozel

MSc,Research assistant

Abant Izzet Baysal University

研究点 (1)

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