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

NCT04952363 | Completed FDA Device

• 1 other identifier: KMUHIRB-E(Ⅱ)-20170267
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (17)

• 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

Study Arms (2)

HFCWO+WBVT

EXPERIMENTAL

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

Device: A vertical vibration platform PowerVibe Zen Pro 5900; Device: HFCWO

HFCWO only

ACTIVE COMPARATOR

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

Device: HFCWO

Interventions

A vertical vibration platform PowerVibe Zen Pro 5900 DEVICE

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+WBVT

HFCWO DEVICE

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.

HFCWO only; HFCWO+WBVT

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 7, 2021
• Study Start: December 22, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 19, 2021

Record last verified: 2021-06

Locations

TW (1)