COPDNCT04952363
Whole-body Vibration on Mucus Clearance, the Quality of Life, and Exercise Capacity for Patients With Chronic Obstructive Pulmonary Disease
A study testing A vertical vibration platform PowerVibe Zen Pro 5900 and HFCWO in people with COPD, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- A vertical vibration platform PowerVibe Zen Pro 5900 and HFCWO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Dec 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of COPD at the outpatient thoracic medicine clinic
- Need HFCWO as judged by the doctor
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COPD
- Being tested
- A vertical vibration platform PowerVibe Zen Pro 5900, HFCWO
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A vertical vibration platform PowerVibe Zen Pro 5900Device
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.
HFCWODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HFCWO+WBVT | Experimental | Subjects received HFCWO+WBVT intervention twice a week for a period of 8 weeks Receives: 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 Receives: Device: HFCWO |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC
forced vital capacity tested in pulmonary function test (Liters)
Measured: 8 weeks
FEV1
forced expiratory volume in 1 second in pulmonary function test (Liters)
Measured: 8 weeks
FEV1/FVC
forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test (%)
Measured: 8 weeks
FVC(% pred)
percentage of predicted FVC value (% pred)
Measured: 8 weeks
FEV1(% pred)
percentage of predicted FEV1 value (% pred)
Measured: 8 weeks
6 min walk distance
the distance walked in 6 minutes (m)
Measured: 8 weeks
Predicted distance
percentage of the predicted 6 minute walk test distance (%pred)
Measured: 8 weeks
Distance-Saturation Product (DSP)
the product of distance walked and lowest oxygen saturation during the 6-min walk test (m%)
Measured: 8 weeks
1 min STST
the number of repetitions performed in the 1-min sit-to-stand test (rep.)
Measured: 8 weeks
5-rep STST
the complete time for the 5-repetition sit-to-stand test (sec)
Measured: 8 weeks
Muscle strength test1
Maximal force output for biceps femoris muscle (lbs)
Measured: 8 weeks
Muscle strength test2
maximal force output for quadriceps muscle (lbs)
Measured: 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
Measured: 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.
Measured: 8 weeks
modified Medical Research Council (mMRC)
questionnaire of dyspnea, scores ranging from 0 (low degree of dyspnea) to 4 (high degree of dyspnea)
Measured: 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
Measured: 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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start22 Dec 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952363
- Sponsor's protocol ID
- KMUHIRB-E(Ⅱ)-20170267
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration Training on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04952363
- Acronym / sponsor ID
- KMUHIRB-E(Ⅱ)-20170267
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFCWO+WBVT | Experimental | Device: A vertical vibration platform PowerVibe Zen Pro 5900, Device: HFCWOSubjects received HFCWO+WBVT intervention twice a week for a period of 8 weeks |
| HFCWO only | Active comparator | Device: HFCWOSubjects received HFCWO intervention twice a week for a period of 8 weeks |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of COPD at the outpatient thoracic medicine clinic
- Need HFCWO as judged by the doctor
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A vertical vibration platform PowerVibe Zen Pro 5900Subjects 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+WBVT |
| HFCWOSubjects 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. | Device | HFCWO only, HFCWO+WBVT |
Primary outcome
FVC
Time frame: 8 weeks
forced vital capacity tested in pulmonary function test (Liters)
FEV1
Time frame: 8 weeks
forced expiratory volume in 1 second in pulmonary function test (Liters)
FEV1/FVC
Time frame: 8 weeks
forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test (%)
FVC(% pred)
Time frame: 8 weeks
percentage of predicted FVC value (% pred)
FEV1(% pred)
Time frame: 8 weeks
percentage of predicted FEV1 value (% pred)
6 min walk distance
Time frame: 8 weeks
the distance walked in 6 minutes (m)
Predicted distance
Time frame: 8 weeks
percentage of the predicted 6 minute walk test distance (%pred)
Distance-Saturation Product (DSP)
Time frame: 8 weeks
the product of distance walked and lowest oxygen saturation during the 6-min walk test (m%)
1 min STST
Time frame: 8 weeks
the number of repetitions performed in the 1-min sit-to-stand test (rep.)
5-rep STST
Time frame: 8 weeks
the complete time for the 5-repetition sit-to-stand test (sec)
Muscle strength test1
Time frame: 8 weeks
Maximal force output for biceps femoris muscle (lbs)
Muscle strength test2
Time frame: 8 weeks
maximal force output for quadriceps muscle (lbs)
Sputum self-assessment scale
Time frame: 8 weeks
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
Time frame: 8 weeks
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)
Time frame: 8 weeks
questionnaire of dyspnea, scores ranging from 0 (low degree of dyspnea) to 4 (high degree of dyspnea)
chronic obstructive pulmonary disease assessment test (CAT)
Time frame: 8 weeks
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)
Time frame: 8 weeks
questionnaire of overall health, daily life, and perceived well-being, scores ranging from 0 (no health impairment) to 100 (maximum health impairment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A vertical vibration platform PowerVibe Zen Pro 5900 and HFCWO in people with COPD, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC (time frame: 8 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.