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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952363
• Other study ID #: KMUHIRB-E(?)-20170267
• Status: Completed
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: June 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVC	forced vital capacity tested in pulmonary function test (Liters)	8 weeks
Primary	FEV1	forced expiratory volume in 1 second in pulmonary function test (Liters)	8 weeks
Primary	FEV1/FVC	forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test (%)	8 weeks
Primary	FVC(% pred)	percentage of predicted FVC value (% pred)	8 weeks
Primary	FEV1(% pred)	percentage of predicted FEV1 value (% pred)	8 weeks
Primary	6 min walk distance	the distance walked in 6 minutes (m)	8 weeks
Primary	Predicted distance	percentage of the predicted 6 minute walk test distance (%pred)	8 weeks
Primary	Distance-Saturation Product (DSP)	the product of distance walked and lowest oxygen saturation during the 6-min walk test (m%)	8 weeks
Primary	1 min STST	the number of repetitions performed in the 1-min sit-to-stand test (rep.)	8 weeks
Primary	5-rep STST	the complete time for the 5-repetition sit-to-stand test (sec)	8 weeks
Primary	Muscle strength test1	Maximal force output for biceps femoris muscle (lbs)	8 weeks
Primary	Muscle strength test2	maximal force output for quadriceps muscle (lbs)	8 weeks
Primary	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
Primary	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
Primary	modified Medical Research Council (mMRC)	questionnaire of dyspnea, scores ranging from 0 (low degree of dyspnea) to 4 (high degree of dyspnea)	8 weeks
Primary	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
Primary	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