Whole-body Vibration on Mucus Clearance, the Quality of Life, and Exercise Capacity for Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Device: A vertical vibration platform PowerVibe Zen Pro 5900
* Device: HFCWO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of COPD at the outpatient thoracic medicine clinic Need HFCWO as judged by the doctor Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFCWO+WBVT<br>Subjects received HFCWO+WBVT intervention twice a week for a period of 8 weeks | Device: A vertical vibration platform PowerVibe Zen Pro 5900<br>* Subjects received the interventions twice a week for 8 weeks. HFCWO+WBVT group received additional 30 minutes WBVT treatment. In every WBVT session, three rounds of 3 minutes of vibration (amplitude: 2 mm; frequency: 20 Hz) were provided, with a 60-second rest between rounds.<br>Device: HFCWO<br>* Subjects received the interventions twice a week for 8 weeks. The HFCWO was delivered by a respiratory therapist using a percussive vest at 10-13 Hz oscillating frequency and at a pressure setting of 2 cm H2O. The treatment duration was 25 minutes, and the participants remained in a sitting position.<br>|
| Active Comparator: HFCWO only<br>Subjects received HFCWO intervention twice a week for a period of 8 weeks | Device: HFCWO<br>* Subjects received the interventions twice a week for 8 weeks. The HFCWO was delivered by a respiratory therapist using a percussive vest at 10-13 Hz oscillating frequency and at a pressure setting of 2 cm H2O. The treatment duration was 25 minutes, and the participants remained in a sitting position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC | forced vital capacity tested in pulmonary function test (Liters) | 8 weeks | 
| FEV1 | forced expiratory volume in 1 second in pulmonary function test (Liters) | 8 weeks | 
| FEV1/FVC | forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test (%) | 8 weeks | 
| FVC(% pred) | percentage of predicted FVC value (% pred) | 8 weeks | 
| FEV1(% pred) | percentage of predicted FEV1 value (% pred) | 8 weeks | 
| 6 min walk distance | the distance walked in 6 minutes (m) | 8 weeks | 
| Predicted distance | percentage of the predicted 6 minute walk test distance (%pred) | 8 weeks | 
| Distance-Saturation Product (DSP) | the product of distance walked and lowest oxygen saturation during the 6-min walk test (m%) | 8 weeks | 
| 1 min STST | the number of repetitions performed in the 1-min sit-to-stand test (rep.) | 8 weeks | 
| 5-rep STST | the complete time for the 5-repetition sit-to-stand test (sec) | 8 weeks | 
| Muscle strength test1 | Maximal force output for biceps femoris muscle (lbs) | 8 weeks | 
| Muscle strength test2 | maximal force output for quadriceps muscle (lbs) | 8 weeks | 
| Sputum self-assessment scale | questionnaire of sputum volume, it contained three items (0-25 mL/d, 25-50 mL/d, and 50-100 mL/d) as a checklist | 8 weeks | 
| X-ray score | 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. | 8 weeks | 
| modified Medical Research Council (mMRC) | questionnaire of dyspnea, scores ranging from 0 (low degree of dyspnea) to 4 (high degree of dyspnea) | 8 weeks | 
| chronic obstructive pulmonary disease assessment test (CAT) | questionnaire of COPD symptoms, scores ranging from 0 to 40, higher scores indicating more severe impact of COPD on their life | 8 weeks | 
| Saint George Respiratory Questionnaire (SGRQ) | questionnaire of overall health, daily life, and perceived well-being, scores ranging from 0 (no health impairment) to 100 (maximum health impairment) | 8 weeks |