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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: A vertical vibration platform PowerVibe Zen Pro 5900; Device: HFCWO

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFCWO+WBVT; Subjects received HFCWO+WBVT intervention twice a week for a period of 8 weeks	Device: A vertical vibration platform PowerVibe Zen Pro 5900; 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.; Device: HFCWO; 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.
Active Comparator: HFCWO only; Subjects received HFCWO intervention twice a week for a period of 8 weeks	Device: HFCWO; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: KMUHIRB-E(Ⅱ)-20170267

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes