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临床试验/NCT04173689
NCT04173689已完成不适用

The Effect of Inspiratory Muscle Training and Breathing Exercises Combined With Upper Extremity and Trunk in Patients With Sarcoidosis

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年1月15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
发起方
入组人数
24
试验地点
1
主要终点
Hospital Anxiety Scale

研究概览

简要总结

This is an educational work. Thirty patients with pulmonary sarcoidosis will be included in the study and randomly selected into two training groups.One group will receive home inspiratory muscle training (IMT) for 15 minutes, twice a day, 7 days a week with the resh Threshold IMT 'device. In the IMT group, the initial training intensity will be determined by measuring the maximal inspiratory muscle strength (MIP) with the intraoral pressure measuring device, 30% of the measured (MIP) value will be started at the first evaluation and the new training intensity will be determined by calculating 30% of the measured value by repeating the MIP measurement every week. The other group will perform upper extremity and trunk exercises combined with respiratory exercises at home for 7 days, twice a day for 15 minutes.Patients will be evaluated before the training program and 8 weeks after the training. In the first evaluation, demographic information and clinical characteristics of the patients will be noted.In this study, upper and lower extremity exercise capacity, respiratory functions, peripheral muscle strength, dyspnea, fatigue, sleep quality, cognitive function, daily living activities, physical activity level, anxiety, depression, upper extremity and trunk exercises combined with inspiratory muscle training in patients with sarcoidosis and the impact on quality of life.

详细描述

Patients who are in stage II-III with sarcoidosis diagnosed pulmonary involvement who are admitted to the Department of Chest Diseases of Cerrahpaşa Medical Faculty Hospital of Istanbul University will be included in the 30-70 age group 6 months after systemic treatment or no treatment. Patients with stages I and IV, malignancy, heart failure, orthopedic problems and who have to undergo systemic sarcoidosis treatment during the study will not be included in the study. Thirty-four patients who meet the inclusion criteria will be included in the study by signing the informed consent form. In the first evaluation, demographic information and clinical characteristics of the patients will be noted. Lower and upper extremity functional capacities of the patients before and after training will be evaluated with 6-minute walk test (6MWT), 6-minute step test (6DST), 6-minute pegboard ring test (6DPBRT) and 30-second sit-down test. Percentage values of FVC, FEV1, FEV1 / FVC, PEF, FEF (25-75%) parameters according to measured and expected values will be recorded by performing pulmonary function test. Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MRP) and maximal expiratory pressure (MEP) with the intraoral pressure gauge. Dyspnea sensation Modified Borg and Modified Medical Research Council (MMRC) scale, fatigue state Fatigue Severity Scale (FSS), peripheral muscle strength hand dynamometer, quality of life George Respiratory Diseases Questionnaire (SGRQ), anxiety and depression status Hospital Anxiety and Depression Scale (HAD), physical activity level International Physical Activity Questionnaire-Short form (IPAQ-S), cognitive function Montreal Cognitive Assessment Scale (MOCA), daily living activities London Chest Daily Living Activities Scale and sleep quality will be evaluated with Epworth Sleepiness Scale (ESS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

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

入选标准

  • •The study was conducted in Istanbul University Cerrahpaşa Medical Faculty Hospital Pulmonary Diseases Department with sarcoidosis diagnosed with pulmonary involvement in stage II-III,
  • •6 months after receiving systemic treatment or no treatment.

排除标准

  • •Patients with stage I and IV,
  • •malignancy,
  • •heart failure,
  • •orthopedic problems
  • •who had to undergo systemic sarcoidosis treatment during the study

研究组 & 干预措施

Inspiratuar muscle training group

Active Comparator

This group will be given inspiratory muscle training (IMT) at home for 15 minutes twice a day for 7 days a week with the resh Threshold IMT 'device. In the IMT group, the initial training intensity will be determined by measuring the maximal inspiratory muscle strength (MRP) with the intraoral pressure measuring device, 30% of the measured MRP value will be started at the first evaluation and the new training intensity will be determined by calculating 30% of the measured value by repeating the MRP measurement every week.

干预措施: Threshold IMT (Device)

Exercise group

Active Comparator

This group will perform upper extremity and trunk exercises combined with breathing exercises at home for 7 days, twice a day for 15 minutes. Patients in both groups will perform a single 15-minute session once a week at the hospital under the supervision of a physiotherapist.

干预措施: breathing exercises combined with upper extremity and trunk (Other)

结局指标

主要结局

Hospital Anxiety Scale

时间窗: 8 week

anxiety 0-21 .high score shows deterioration

Montreal Cognitive Assessment Scale

时间窗: 8 week

assess cognitive functions of individuals.0-30. high score indicates improvement

Fatigue severity scale

时间窗: 8 week

0-7. high score shows deterioration. \<2,8 no fatigue. \>6,1 chronic fatigue syndrome

6 minute walk test

时间窗: 8 week

Increased walking distance in 6 minutes

Epworth sleepiness scale

时间窗: 8 week

0-30. high score shows deterioration

Hospital Depression Scale

时间窗: 8 week

depression 0-21. high score shows deterioration

Medical Research Council Dyspnea Scale

时间窗: 8 week

0-4. high score shows deterioration

Respiratory assesment

时间窗: 8 week

measure respiratory muscle strength

London Chest Daily Living Activities Scale

时间窗: 8 week

Measuring daily living activities. high score shows deterioration. 0-75

次要结局

未报告次要终点

研究者

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

Esma Yildiz

Physiotherapist

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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