COPDNCT06413524
The Effects of Different Vibration Exercises on COPD Patients
A study testing Whole-body Vibration Therapy and Local Vibration Therapy in people with COPD and COPD Chronic Obstructive Pulmonary Disease, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Pulmonary rehabilitation is effective in improving exercise tolerance, dyspnea, and fatigue in patients with COPD, and exercise training is an important component of pulmonary rehabilitation. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- COPD, COPD Chronic Obstructive Pulmonary Disease, Vibration Therapy
- What is being tested?
- Whole-body Vibration Therapy and Local Vibration Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Aug 2024to 13 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40.
- Diagnosis of chronic obstructive pulmonary disease (COPD) based on the criteria established by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- Disease Severity: FEV1 \< 50% or COPD patients who have used systemic corticosteroids due to an acute exacerbation of COPD within the past year and are currently in a stable condition.
- Willingness to participate in vibration exercise intervention and ability to comply with the study activities, including signing the informed consent form.
- Clear consciousness, normal cognitive function, and ability to communicate in Mandarin or Taiwanese for understanding experimental procedures and relevant instructions.
Who cannot join
- Engages in regular physical activity, exercising at least 3 times a week for over 30 minutes, with a Borg Scale rating of 3 for breathlessness after exercise.
- The interval since the last pulmonary rehabilitation is less than three months.
- Contraindications to vibration therapy: pregnancy, cardiovascular diseases (with a pacemaker or stent), intervertebral disc diseases, tendinitis, arthritis, hernia, presence of tumors, orthopedic or trauma-related conditions, epilepsy, history of deep vein thrombosis, patients with internal implants.
- Inability to undergo training or walk due to physical factors, such as being bedridden for an extended period, relying on a ventilator for an extended period, prone to dizziness, central nervous system disorders, etc.
- Underwent lower limb-related surgery within the past year or is in the recovery period post-surgery.
- Currently diagnosed with cancer or undergoing cancer treatment.
- Participation in other research studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University WanFang Hospital
Taipei, Wenshan Dist, 116
XUANYU LIAO, Master student, 0229307930 ext. 2968, cherry85420@gmail.com
About this study
Official title: The Effects of Different Vibration Exercises on the Strength of Lower Extremity Muscles, Exercise Endurance, and Quality of Life Among COPD Patients
Pulmonary rehabilitation is effective in improving exercise tolerance, dyspnea, and fatigue in patients with COPD, and exercise training is an important component of pulmonary rehabilitation. Vibration training can be used as a supplement or alternative to traditional exercise and is a short, safe rehabilitation training.
COPD patients will be recruited and randomly assigned to the control group, whole-body vibration training group, or local vibration training group. The study aims to confirm the rehabilitative benefits of enhancing lower limb muscle strength, exercise endurance, and the quality of life related to COPD in patients.
Read the detailed description
Background Pulmonary rehabilitation is effective in improving exercise tolerance, dyspnea, and fatigue in patients with COPD, and exercise training is an important component of pulmonary rehabilitation. Vibration training can be used as a supplement or alternative to traditional exercise and is a short, safe rehabilitation training.
Purpose To enhance the effectiveness of pulmonary rehabilitation, the vibration rehabilitation system will be applied on COPD patients to validate the effectiveness of direct and indirect vibration interventions on lower extremity muscle strength and functional performance in COPD patients, and test the effectiveness of vibration in improving lower extremity muscle strength, exercise tolerance, and COPD- related quality of life in COPD patients.
Methods COPD patients will be recruited and randomly assigned to the control group, whole-body vibration training group, or local vibration training group. The study aims to confirm the rehabilitative benefits of enhancing lower limb muscle strength, exercise endurance, and the quality of life related to COPD in patients.
Expected outcome To establish an optimal model for lower extremity vibration and to validate the effectiveness of direct vibration on the lower extremities and whole body vibration in COPD patients undergoing pulmonary rehabilitation.
- Being tested
- Whole-body Vibration Therapy, Local Vibration Therapy
- 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.
Whole-body Vibration TherapyDevice
Each session includes six series, each lasting 2 minutes, with a frequency of 35 Hz and an amplitude of 2 mm, with a 60-second rest interval between series. For the starting position, the patient stands relaxed on the platform, holding the WBV platform handles.
Local Vibration TherapyDevice
Each session includes six series, each lasting 2 minutes, with a frequency of 35 Hz and an amplitude of 2 mm, with a 60-second rest interval between series. After the warm-up exercise, the researcher helps the patient wear the localized vibration instrument. During the vibration, participants will hold onto the handle to ensure balance stability.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body Vibration Training Group | Experimental | Receive whole-body vibration twice a week for 12 weeks. Receives: Device: Whole-body Vibration Therapy |
| Local Vibration Training Group | Experimental | Receive local vibration twice a week for 12 weeks. Receives: Device: Local Vibration Therapy |
| Control Group | No intervention | Receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walking Test
This test measures how far the patient can walk in 6 minutes, with a greater distance indicating better performance.
Measured: Base line, Week12, Week16
Maximal voluntary contraction force
The readings from the digital dynamometer can be converted into kilograms, with higher values indicating greater muscle strength.
Measured: Base line, Week12, Week16
Secondary outcomes (4)
Five Times Sit to Stand Test (FTSST)
Score is the amount of time it takes for an patient to transfer from a seated position to standing position and back to sitting five times. A shorter time indicates better performance.
Measured: Base line, Week12, Week16
Clinical COPD Questionnaire score, CCQ
The scale ranges from 0 to 6, where higher scores reflect more severe conditions.
Score Range:
0: No impact or impairment. 6: Severe impact or impairment.
Measured: Base line, Week12, Week16
COPD assessment Test, CAT
CAT has a scoring range of zero to 40; higher scores indicate a greater severity of COPD's impact on a patient's life.
Measured: Base line, Week12, Week16
mMRC dyspnea scale, mMRC
The scale ranges from 0 to 4, with higher scores representing more severe conditions.
Measured: Base line, Week12, Week16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start8 Aug 2024
- Primary completion21 Apr 2025 (estimated)
- Study completion13 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413524
- Sponsor's protocol ID
- N202403010
- Status last verified
- Jan 2025
- First submitted
- 9 May 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DadeMatthews OO, Agostinelli PJ, Neal FK, Oladipupo SO, Hirschhorn RM, Wilson AE, Sefton JM. Systematic review and meta-analyses on the effects of whole-body vibration on bone health. Complement Ther Med. 2022 May;65:102811. doi: 10.1016/j.ctim.2022.102811. Epub 2022 Jan 29.
PubMed 35093509Iodice P, Bellomo RG, Gialluca G, Fano G, Saggini R. Acute and cumulative effects of focused high-frequency vibrations on the endocrine system and muscle strength. Eur J Appl Physiol. 2011 Jun;111(6):897-904. doi: 10.1007/s00421-010-1677-2. Epub 2010 Nov 10.
PubMed 21063726Gupta N, Pinto LM, Morogan A, Bourbeau J. The COPD assessment test: a systematic review. Eur Respir J. 2014 Oct;44(4):873-84. doi: 10.1183/09031936.00025214. Epub 2014 Jul 3.
PubMed 24993906Djibo DA, Goldstein J, Ford JG. Prevalence of disability among adults with chronic obstructive pulmonary disease, Behavioral Risk Factor Surveillance System 2016-2017. PLoS One. 2020 Feb 27;15(2):e0229404. doi: 10.1371/journal.pone.0229404. eCollection 2020.
PubMed 32106254Berner K, Albertyn SCS, Dawnarain S, Hendricks LJ, Johnson J, Landman A, Burger M. The effectiveness of combined lower limb strengthening and whole-body vibration, compared to strengthening alone, for improving patient-centred outcomes in adults with COPD: A systematic review. S Afr J Physiother. 2020 Jun 11;76(1):1412. doi: 10.4102/sajp.v76i1.1412. eCollection 2020.
PubMed 32671277
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Vibration Exercises on the Strength of Lower Extremity Muscles, Exercise Endurance, and Quality of Life Among COPD Patients
- ClinicalTrials.gov ID
- NCT06413524
- Acronym / sponsor ID
- N202403010
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 21 Apr 2025 (estimated)
- Study completion
- 13 Jun 2025 (estimated)
- First posted
- 14 May 2024 (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.
Pulmonary rehabilitation is effective in improving exercise tolerance, dyspnea, and fatigue in patients with COPD, and exercise training is an important component of pulmonary rehabilitation. Vibration training can be used as a supplement or alternative to traditional exercise and is a short, safe rehabilitation training.
COPD patients will be recruited and randomly assigned to the control group, whole-body vibration training group, or local vibration training group. The study aims to confirm the rehabilitative benefits of enhancing lower limb muscle strength, exercise endurance, and the quality of life related to COPD in patients.
Detailed description
Background Pulmonary rehabilitation is effective in improving exercise tolerance, dyspnea, and fatigue in patients with COPD, and exercise training is an important component of pulmonary rehabilitation. Vibration training can be used as a supplement or alternative to traditional exercise and is a short, safe rehabilitation training.
Purpose To enhance the effectiveness of pulmonary rehabilitation, the vibration rehabilitation system will be applied on COPD patients to validate the effectiveness of direct and indirect vibration interventions on lower extremity muscle strength and functional performance in COPD patients, and test the effectiveness of vibration in improving lower extremity muscle strength, exercise tolerance, and COPD- related quality of life in COPD patients.
Methods COPD patients will be recruited and randomly assigned to the control group, whole-body vibration training group, or local vibration training group. The study aims to confirm the rehabilitative benefits of enhancing lower limb muscle strength, exercise endurance, and the quality of life related to COPD in patients.
Expected outcome To establish an optimal model for lower extremity vibration and to validate the effectiveness of direct vibration on the lower extremities and whole body vibration in COPD patients undergoing pulmonary rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole-body Vibration Training Group | Experimental | Device: Whole-body Vibration TherapyReceive whole-body vibration twice a week for 12 weeks. |
| Local Vibration Training Group | Experimental | Device: Local Vibration TherapyReceive local vibration twice a week for 12 weeks. |
| Control Group | No intervention | –Receive no intervention |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 40.
- Diagnosis of chronic obstructive pulmonary disease (COPD) based on the criteria established by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- Disease Severity: FEV1 \< 50% or COPD patients who have used systemic corticosteroids due to an acute exacerbation of COPD within the past year and are currently in a stable condition.
- Willingness to participate in vibration exercise intervention and ability to comply with the study activities, including signing the informed consent form.
- Clear consciousness, normal cognitive function, and ability to communicate in Mandarin or Taiwanese for understanding experimental procedures and relevant instructions.
Key exclusion criteria (7 listed)
- Engages in regular physical activity, exercising at least 3 times a week for over 30 minutes, with a Borg Scale rating of 3 for breathlessness after exercise.
- The interval since the last pulmonary rehabilitation is less than three months.
- Contraindications to vibration therapy: pregnancy, cardiovascular diseases (with a pacemaker or stent), intervertebral disc diseases, tendinitis, arthritis, hernia, presence of tumors, orthopedic or trauma-related conditions, epilepsy, history of deep vein thrombosis, patients with internal implants.
- Inability to undergo training or walk due to physical factors, such as being bedridden for an extended period, relying on a ventilator for an extended period, prone to dizziness, central nervous system disorders, etc.
- Underwent lower limb-related surgery within the past year or is in the recovery period post-surgery.
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 |
|---|---|---|
| Whole-body Vibration TherapyEach session includes six series, each lasting 2 minutes, with a frequency of 35 Hz and an amplitude of 2 mm, with a 60-second rest interval between series. For the starting position, the patient stands relaxed on the platform, holding the WBV platform handles. | Device | Whole-body Vibration Training Group |
| Local Vibration TherapyEach session includes six series, each lasting 2 minutes, with a frequency of 35 Hz and an amplitude of 2 mm, with a 60-second rest interval between series. After the warm-up exercise, the researcher helps the patient wear the localized vibration instrument. During the vibration, participants will hold onto the handle to ensure balance stability. | Device | Local Vibration Training Group |
Primary outcome
6 Minute Walking Test
Time frame: Base line, Week12, Week16
This test measures how far the patient can walk in 6 minutes, with a greater distance indicating better performance.
Maximal voluntary contraction force
Time frame: Base line, Week12, Week16
The readings from the digital dynamometer can be converted into kilograms, with higher values indicating greater muscle strength.
4 secondary outcomes
Five Times Sit to Stand Test (FTSST)
Time frame: Base line, Week12, Week16
Clinical COPD Questionnaire score, CCQ
Time frame: Base line, Week12, Week16
COPD assessment Test, CAT
Time frame: Base line, Week12, Week16
mMRC dyspnea scale, mMRC
Time frame: Base line, Week12, Week16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 35093509DadeMatthews OO, Agostinelli PJ, Neal FK, Oladipupo SO, Hirschhorn RM, Wilson AE, Sefton JM. Systematic review and meta-analyses on the effects of whole-body vibration on bone health. Complement Ther Med. 2022 May;65:102811. doi: 10.1016/j.ctim.2022.102811. Epub 2022 Jan 29.
- Background: PubMed 21063726Iodice P, Bellomo RG, Gialluca G, Fano G, Saggini R. Acute and cumulative effects of focused high-frequency vibrations on the endocrine system and muscle strength. Eur J Appl Physiol. 2011 Jun;111(6):897-904. doi: 10.1007/s00421-010-1677-2. Epub 2010 Nov 10.
- Background: PubMed 24993906Gupta N, Pinto LM, Morogan A, Bourbeau J. The COPD assessment test: a systematic review. Eur Respir J. 2014 Oct;44(4):873-84. doi: 10.1183/09031936.00025214. Epub 2014 Jul 3.
- Background: PubMed 32106254Djibo DA, Goldstein J, Ford JG. Prevalence of disability among adults with chronic obstructive pulmonary disease, Behavioral Risk Factor Surveillance System 2016-2017. PLoS One. 2020 Feb 27;15(2):e0229404. doi: 10.1371/journal.pone.0229404. eCollection 2020.
- Background: PubMed 32671277Berner K, Albertyn SCS, Dawnarain S, Hendricks LJ, Johnson J, Landman A, Burger M. The effectiveness of combined lower limb strengthening and whole-body vibration, compared to strengthening alone, for improving patient-centred outcomes in adults with COPD: A systematic review. S Afr J Physiother. 2020 Jun 11;76(1):1412. doi: 10.4102/sajp.v76i1.1412. eCollection 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body Vibration Therapy and Local Vibration Therapy in people with COPD and COPD Chronic Obstructive Pulmonary Disease, run by Taipei Medical University 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Huei Lin, Associate professor (0227361661 ext. 3620, gracelin@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walking Test (time frame: Base line, Week12, Week16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06413524, which also lists 5 linked publications.
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 16 Jan 2025.