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临床试验/NCT04084405
NCT04084405已完成不适用

Effect of Inspiratory Muscle Training on Balance During PR in Chronic Obstructive Pulmonary Disease Patients (COPD)

Faculty of Medicine, Sousse2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Timed Up and Go (TUG)

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress. Physiopathological features of COPD suggest that people who suffer from this disease have many risk factors for falls that have been identified in older individuals.

The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme (PRP) is uncertain. The investigators aimed to demonstrate that,in chronic obstructive pulmonary disease (COPD) patients, IMT performed during a PRP is associated with an improvement of Balance.

详细描述

Chronic obstructive pulmonary disease COPD is a preventable and treatable disease(GOLD, 2017). According to the WHO, COPD would be the third leading cause of death by 2030 (WHO, 2017). This disease is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases(GOLD, 2017). However, emerging data showed that COPD patients demonstrate important deficits in balance and control which associated to a high risk of fall ( Butcher et al, 2004 ; Smith et al, 2009 ; Beauchamp et al, 2009 ; Beauchamp et al, 2010). Inspiratory muscle training (IMT) has been shown to be an effective modality for COPD patients for improving the maximal inspiratory muscle strength, the dyspnea and health-related quality of life (GI COPD, 2016). However, the effect of inspiratory muscle training on balance is not studying. The purpose of this study is to evaluate the effect of the inspiratory muscles training on balance in COPD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Were COPD diagnosed by pulmonary function testing
  • clinically stable
  • abscence of other obstructive diseases
  • signed written consert.

排除标准

  • Were previous pneumonectomy or lobectomy in the past 6 months
  • spontaneous risk of pneumothorax or rib fracture
  • incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
  • the absence of written informed consent.

结局指标

主要结局

Timed Up and Go (TUG)

时间窗: Baseline, 2 months follow up

The test requires the patient to rise from a standard armchair, walk 3 m at a comfortable pace, walk back to the chair, and sit down

Inspiratory muscle strengh

时间窗: Baseline, 2 months follow up

The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure

ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC)

时间窗: Baseline, 2 months follow up

The ABC scale requires patients to indicate their confidence in performing 16 activities without losing their balance or becoming unsteady on an 11-point scale (0%-100%).Higher scores indicates higher balance confidence and lower scores indicates poor balance confidence

Berg Balance Scale (BBS)

时间窗: Baseline, 2 months follow up

The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.

Single Leg Stance (SLS)

时间窗: Baseline, 2 months follow up

Patients selected the leg on which they they preferred to stand for the test. They were instructed to keep their legs from touching and to maintain a unipedal stance for as long as possible

次要结局

  • The six minutes walk test (6MWT)(Baseline, 2 months follow up)

研究者

发起方
Faculty of Medicine, Sousse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bilel Tounsi

PhD student

Faculty of Medicine, Sousse

研究点 (2)

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