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临床试验/NCT04952363
NCT04952363已完成不适用

The Effect of Whole Body Vibration Training on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年12月22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
26
试验地点
1
主要终点
FVC(% pred)

研究概览

简要总结

Although whole body vibration (WBV) is mainly designed to promote neuromuscular function, however, because of its vibration characteristics, whether it can provide additional effects on the sputum clearance for chronic obstructive pulmonary (COPD) disease patients, thereby improving the quality of life, and exercise capacity is still unknown.

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, Investigator)

入排标准

年龄范围
35 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Confirmed diagnosis of COPD at the outpatient thoracic medicine clinic
  • •Need HFCWO as judged by the doctor

排除标准

  • •Acute COPD exacerbation within the previous 4 weeks,
  • •Contraindication for WBVT (e.g., artificial joint replacement, a history of deep vein thrombosis, or known aortic aneurysm)
  • •Inability to perform squatting exercises
  • •Acute disc disease
  • •Inability to complete the 6MWT

研究组 & 干预措施

HFCWO+WBVT

Experimental

Subjects received HFCWO+WBVT intervention twice a week for a period of 8 weeks

干预措施: A vertical vibration platform PowerVibe Zen Pro 5900 (Device)

HFCWO+WBVT

Experimental

Subjects received HFCWO+WBVT intervention twice a week for a period of 8 weeks

干预措施: HFCWO (Device)

HFCWO only

Active Comparator

Subjects received HFCWO intervention twice a week for a period of 8 weeks

干预措施: HFCWO (Device)

结局指标

主要结局

FVC(% pred)

时间窗: 8 weeks

percentage of predicted FVC value (% pred)

chronic obstructive pulmonary disease assessment test (CAT)

时间窗: 8 weeks

questionnaire of COPD symptoms, scores ranging from 0 to 40, higher scores indicating more severe impact of COPD on their life

1 min STST

时间窗: 8 weeks

the number of repetitions performed in the 1-min sit-to-stand test (rep.)

FVC

时间窗: 8 weeks

forced vital capacity tested in pulmonary function test (Liters)

Distance-Saturation Product (DSP)

时间窗: 8 weeks

the product of distance walked and lowest oxygen saturation during the 6-min walk test (m%)

FEV1/FVC

时间窗: 8 weeks

forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test (%)

Predicted distance

时间窗: 8 weeks

percentage of the predicted 6 minute walk test distance (%pred)

5-rep STST

时间窗: 8 weeks

the complete time for the 5-repetition sit-to-stand test (sec)

Muscle strength test2

时间窗: 8 weeks

maximal force output for quadriceps muscle (lbs)

X-ray score

时间窗: 8 weeks

the evaluation of the chest radiography based on the sputum impaction score, scores ranging from 0 to 18. A decrease in score represented an improvement in sputum in each area.

modified Medical Research Council (mMRC)

时间窗: 8 weeks

questionnaire of dyspnea, scores ranging from 0 (low degree of dyspnea) to 4 (high degree of dyspnea)

Saint George Respiratory Questionnaire (SGRQ)

时间窗: 8 weeks

questionnaire of overall health, daily life, and perceived well-being, scores ranging from 0 (no health impairment) to 100 (maximum health impairment)

FEV1

时间窗: 8 weeks

forced expiratory volume in 1 second in pulmonary function test (Liters)

FEV1(% pred)

时间窗: 8 weeks

percentage of predicted FEV1 value (% pred)

6 min walk distance

时间窗: 8 weeks

the distance walked in 6 minutes (m)

Muscle strength test1

时间窗: 8 weeks

Maximal force output for biceps femoris muscle (lbs)

Sputum self-assessment scale

时间窗: 8 weeks

questionnaire of sputum volume, it contained three items (0-25 mL/d, 25-50 mL/d, and 50-100 mL/d) as a checklist

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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