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

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
A vertical vibration platform PowerVibe Zen Pro 5900
HFCWO
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HFCWO+WBVT

HFCWO only

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 24, 2021
Last Updated
August 17, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04952363
Brief Title
Whole-body Vibration on Mucus Clearance, the Quality of Life, and Exercise Capacity for Patients With Chronic Obstructive Pulmonary Disease
Official Title
The Effect of Whole Body Vibration Training on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFCWO+WBVT
Arm Type
Experimental
Arm Description
Subjects received HFCWO+WBVT intervention twice a week for a period of 8 weeks
Arm Title
HFCWO only
Arm Type
Active Comparator
Arm Description
Subjects received HFCWO intervention twice a week for a period of 8 weeks
Intervention Type
Device
Intervention Name(s)
A vertical vibration platform PowerVibe Zen Pro 5900
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HFCWO
Intervention Description
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.
Primary Outcome Measure Information:
Title
FVC
Description
forced vital capacity tested in pulmonary function test (Liters)
Time Frame
8 weeks
Title
FEV1
Description
forced expiratory volume in 1 second in pulmonary function test (Liters)
Time Frame
8 weeks
Title
FEV1/FVC
Description
forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test (%)
Time Frame
8 weeks
Title
FVC(% pred)
Description
percentage of predicted FVC value (% pred)
Time Frame
8 weeks
Title
FEV1(% pred)
Description
percentage of predicted FEV1 value (% pred)
Time Frame
8 weeks
Title
6 min walk distance
Description
the distance walked in 6 minutes (m)
Time Frame
8 weeks
Title
Predicted distance
Description
percentage of the predicted 6 minute walk test distance (%pred)
Time Frame
8 weeks
Title
Distance-Saturation Product (DSP)
Description
the product of distance walked and lowest oxygen saturation during the 6-min walk test (m%)
Time Frame
8 weeks
Title
1 min STST
Description
the number of repetitions performed in the 1-min sit-to-stand test (rep.)
Time Frame
8 weeks
Title
5-rep STST
Description
the complete time for the 5-repetition sit-to-stand test (sec)
Time Frame
8 weeks
Title
Muscle strength test1
Description
Maximal force output for biceps femoris muscle (lbs)
Time Frame
8 weeks
Title
Muscle strength test2
Description
maximal force output for quadriceps muscle (lbs)
Time Frame
8 weeks
Title
Sputum self-assessment scale
Description
questionnaire of sputum volume, it contained three items (0-25 mL/d, 25-50 mL/d, and 50-100 mL/d) as a checklist
Time Frame
8 weeks
Title
X-ray score
Description
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.
Time Frame
8 weeks
Title
modified Medical Research Council (mMRC)
Description
questionnaire of dyspnea, scores ranging from 0 (low degree of dyspnea) to 4 (high degree of dyspnea)
Time Frame
8 weeks
Title
chronic obstructive pulmonary disease assessment test (CAT)
Description
questionnaire of COPD symptoms, scores ranging from 0 to 40, higher scores indicating more severe impact of COPD on their life
Time Frame
8 weeks
Title
Saint George Respiratory Questionnaire (SGRQ)
Description
questionnaire of overall health, daily life, and perceived well-being, scores ranging from 0 (no health impairment) to 100 (maximum health impairment)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan

12. IPD Sharing Statement

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

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