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临床试验/NCT03335891
NCT03335891已完成不适用

The Effects of Core Stabilization Training on Dynamic Balance and Pulmonary Parameters Among Patients With Asthma: A Randomized Controlled Trial

Yeditepe University0 个研究点目标入组 51 人开始时间: 2015年11月最近更新:
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
51
主要终点
Maximum Inspiratory Pressure

研究概览

简要总结

Objective: To investigate the effectiveness of core stabilization exercises combined with the patient education program (AEP) and breathing exercises in patients with asthma.

Design: A randomized controlled study Setting: Chest diseases clinic of a university hospital. Subjects: The study sample consists of 26-68 years old asthma patients who were diagnosed at least 6 month prior to the study.

Interventions: All subjects were included in the asthma education program (AEP) and both groups were trained for diaphragmatic and pursed lip breathing exercises (2times/wk. 6-week duration at clinic). The core stabilization program was applied twice a week for a duration of 6 weeks in TG.

Main Measures: Spirometry, maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), International Physical Activity Questionnaire Short Form (IPAQ), Hospital Anxiety and Depression Scale(HADS), Asthma Quality of Life Questionnaire(AQOL), Six-minute walking test(6MWT), Prokin PK200, Italy were used to evaluate feasibility of interventions.

详细描述

All volunteers received an asthma education program (AEP) and trained for diaphragmatic and pursed lip breathing exercises. Additionally, the TG participated in the core stabilization exercises program combined with AEP and breathing exercises. Data were collected from all the patients at baseline and post interventions (6 week) by the same physiotherapist who also supervised the exercise sessions.

All subjects were included in the asthma education program (AEP). AEP was performed at least once for approximately 20 minutes via face to face interviews. Education topics covered description of asthma, physiological changes of lungs, risk factors, treatment methods, relaxation positions to reduce dyspnea and usage of a specific inhaler. Breathing exercises were comprised of instructing breathing control, diaphragmatic breathing and pursed lip breathing exercises. Participants attended breathing exercises training for 2 days at the clinic under the supervision of a physiotherapist and 3 days at home as a home-exercise program. Total duration of breathing exercises lasted for 6 weeks. TG performed core stabilization exercises combined with breathing control for 2 days/a week for the duration of 6 weeks under the supervision of a physiotherapist at the clinic. Basic knowledges on spine, muscles of core stabilization and working principle of diaphragm and biofeedback unit (SPB) (Chattanooga Stabilizer Pressure Biofeedback, USA) were explained before the training. The SPB consists of an inflation pump and a cell like sphygmomanometer, which reflects body spinal movement in terms of mmHg by changing pressure in air filled cells. The SPB was placed under the lumbar 5th vertebra and patients attempted to maintain their core stability performing neutral zones at the settled level of 40 mmHg pressure. Furthermore, physiotherapist tried to improve thoracolumbar awareness by following changes from SPB and volunteers assured a constant lumbar position during upper and lower extremity movements combined with diaphragmatic movements. The 6 week exercise protocol emphasized core muscle co-contraction in hook-lying position with a flat cushion between two knees to provide integration between the pelvic floor muscles and diaphragm. Subsequently, exercises progressed as diaphragmatic breathing, flexion of both shoulder with breathing control and extending knees bilaterally with breathing control. Moreover, the hold time and the number of repetitions were increased from 5 repeats x 1 set to 5 repeats x 4 sets and each session lasted 20 minutes.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participating to the study in a voluntary basis.
  • Being 18 years old and upper
  • Getting diagnosed with asthma at least 6 months before.

排除标准

  • Having an asthma attack in last 2 weeks.
  • Having physical and/or mental disability.
  • Having visual, hearing and/or verbal impairments.

研究组 & 干预措施

Training Group

Experimental

Asthma Education Program Breathing Exercises Core Stabilization Exercises

干预措施: Core Stabilization Exercises (Procedure)

Training Group

Experimental

Asthma Education Program Breathing Exercises Core Stabilization Exercises

干预措施: Control (Procedure)

Control Group

Active Comparator

Asthma Education Program Breathing Exercises

干预措施: Control (Procedure)

结局指标

主要结局

Maximum Inspiratory Pressure

时间窗: Six Weeks

The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength

Functional Capacity Test

时间窗: Six Weeks

The Six Minute Walking Test was used to evaluate functional capacity of volunteers. 6MWT was performed on a 30 meter corridor in the clinic according to American Thoracic Society guidelines. Walking distance was calculated.

Forced vital capacity in 1 second (FEV1)

时间窗: Six Weeks

Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

Quality of life

时间窗: Six Weeks

Asthma Quality of Life Scale (AQOL) was utilized to assess quality of life of participants over two weeks prior to the interview which was validated for the Turkish population.l

Maximum Expiratory Pressure

时间窗: Six Weeks

The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength

Functional Vital Capacity (FVC)

时间窗: Six Weeks

Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

Tiffeneau Ratio (FEV1/FVC)

时间窗: Six Weeks

Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

Forced Expiratory Flow from 25 % to 75 % of Vital Capacity (FEF25-75)

时间窗: Six Weeks

Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

次要结局

  • Physical Activity(Six Weeks)
  • Depression level(Six Weeks)
  • Anxiety level(Six Weeks)
  • Dynamic balance(Six Weeks)

研究者

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

Elif Develi

Teaching Assistant

Yeditepe University

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