About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Whole-body Vibration Therapy
DeviceEach 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 Therapy
DeviceEach 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.
Treatment groups
Trial outcomes
Primary outcomes
6 Minute Walking Test
This test measures how far the patient can walk in 6 minutes, with a greater distance indicating better performance.
Maximal voluntary contraction force
The readings from the digital dynamometer can be converted into kilograms, with higher values indicating greater muscle strength.
Secondary outcomes
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.
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.
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.
mMRC dyspnea scale, mMRC
The scale ranges from 0 to 4, with higher scores representing more severe conditions.
Sponsors and contacts
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Taipei Medical University
Lead sponsor
Taipei Medical University WanFang Hospital
Collaborator