Chronic Obstructive Pulmonary Disease (COPD), Whole Body Vibration
Conditions
Brief summary
Chronic obstructive pulmonary disease (COPD) is an irreversible disorder characterized by persistent airflow limitation and increased lung compliance. It leads to dyspnea, skeletal muscle dysfunction, impaired functional capacity, and reduced quality of life. Physical inactivity is considered a major contributor to symptom deterioration, the development of a vicious cycle, and ultimately increased mortality. According to the American College of Sports Medicine (ACSM), the American Thoracic Society (ATS), and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), pulmonary rehabilitation should include aerobic and resistance exercise for at least 20 minutes per session, performed three to five times per week for a minimum of 12 weeks. Exercise intensity should be progressively increased to exceed 60% of peak oxygen uptake (VO₂peak), and patients are encouraged to maintain long-term exercise habits. However, there is still no consensus regarding the optimal initial intensity, progression strategy, and exercise duration. Previous studies have demonstrated that whole-body vibration (WBV) can improve lower extremity muscle strength, functional capacity, and quality of life in patients with COPD. However, its effects on lung function and the optimal training dose remain unclear. In addition, COPD also affects respiratory muscles, upper extremity strength and flexibility, as well as cardiac autonomic function. Therefore, the aim of this study is to investigate the effects of different WBV frequencies on lung function, respiratory muscle function, upper extremity strength and flexibility, and cardiac autonomic function, in order to determine the optimal training dose.
Interventions
All participants will receive three different frequencies of WBV (15, 25, and 35 Hz) in a block-randomized order, with a washout period of at least 7 days between conditions. Subsequently, participants will undergo three additional sessions at the final randomized frequency over one week to evaluate the cumulative effects.
Sponsors
Study design
Eligibility
Inclusion criteria
Healthy individuals Inclusion Criteria: * No prior experience with whole-body vibration therapy or exposure to vibration-related occupations or sports. * Aged between 18 and 65 years.
Exclusion criteria
* Pregnancy. * Acute thrombosis. * Severe cardiovascular disease. * Presence of a cardiac pacemaker. * Recent wounds due to injury or surgery. * Hip or knee implants. * Acute hernia, intervertebral disc degeneration, or spondylolysis. * Severe diabetes mellitus. * Epilepsy. * Recent infection. * Severe migraine. * Tumor. * Recently implanted intrauterine device, metal pins, or metal plates. * Kidney stones. * Organ failure. * Presence of musculoskeletal, respiratory, neurological, cardiovascular conditions, or any form of acute or chronic pain. * Participation in other research studies concurrently. * Regular exercise habits (engaging in moderate-intensity exercise ≥3 times per week). COPD Inclusion Criteria: * Clinically diagnosed with chronic obstructive pulmonary disease (COPD) and classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II, III, or IV. * No history of hospitalization within the past two months. * No participation in any rehabilitation program within the past two months. * Able to comply with the exercise training program. * Aged 18 years or older.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function test | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Pulmonary function test is examined by spirometry, which measures the ability to inhale and exhale air over time. The results include forced vital capacity (FVC in L), forced exploratory volume in the first second (FEV1 in L), and the FVC/FEV1 ratio. |
| Diaphragm excursion and thickness | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Diaphragm excursion (unit: mm) and thickness (unit: mm) are examined by diaphragmatic ultrasound when a participant performs maximal inspiration and expiration. |
| Respiratory muscle strength | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Respiratory muscle strength is measured using a manometer, which records both maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in cmH₂O |
| cardiopulmonary response | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | A cardiopulmonary exercise test collects gases (including measures of oxygen consumption, carbon dioxide production in ml/kg/min) and records heart rate (beat/min), which can be used to estimate cardiopulmonary response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper limb muscle strength | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Maximal voluntary contraction of upper limbs muscles. (unit: N) |
| Handgrip strength | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Maximal voluntary handgrip strength. (unit: N) |
| Upper limb flexibility | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Flexibility is examined by scratch test (unit: cm) |
| Heart rate variability (Standard Deviation of Normal-to Normal intervals, SDNN) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Heart rate variability (HRV) is examined to assess the automatic nervous system. Standard deviation of normal-to-normal (SDNN in ms) reflects overall heart rate variability and automatic function |
| Heart rate variability (Root mean square of successive differences, RMSSD) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Root mean square of successive differences (RMSSD in ms) represents short-term HRV and parasympathetic activity |
| Heart rate variability (Low frequency, LF) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | Low frequency power (LF in ms2) reflects both sympathetic and parasympathetic modulation. |
| Heart rate variability (High frequency power, HF) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | High frequency power (HF in ms2) reflects parasympathetic (vagal) activity. |
| Heart rate variability (LF/HF ratio) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | LF/HF ratio represents sympathovagal balance. |
| St. George's Respiratory Questionnaire (SGRQ) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | The St. George's Respiratory Questionnaire (SGRQ) is a standardized self-administered tool designed to measure the impact of chronic respiratory diseases, such as COPD and asthma, on a patient's health-related quality of life. It consists of 50 items divided into three domains-Symptoms, Activity, and Impacts-with scores ranging from 0 to 100, where a higher score indicates greater impairment. In clinical research and practice, a decrease of 4 points is typically recognized as the Minimal Clinically Important Difference (MCID), signifying a meaningful improvement in the patient's well-being. |
| COPD Assessment Test (CAT) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | The COPD Assessment Test (CAT) is a concise, 8-item self-administered questionnaire designed to provide a simple and reliable measure of the health status of patients with Chronic Obstructive Pulmonary Disease (COPD). Unlike more complex tools, it evaluates a broad range of symptoms-including cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep, and energy levels-using a 6-point scale (0-5) for each item. The total score ranges from 0 to 40, where a score of 10 or higher typically indicates a significant impact of the disease on daily life, making it a highly practical instrument for routine clinical monitoring and patient management. |
| Fatigue Severity Scale (FSS) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | The fatigue severity scale (FSS) is a 7-point scale questionnaire that measures the patients's level of fatigue. It contains 9 questions, and a total score of 36 points or higher indicates that the patient may be experiencing clinically significant fatigue and requires further evaluation. |
| Modified Medical Research Council (mMRC) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | The modified medical research council (mMRC) dyspnea scale consists of 4 levels that describe respiratory difficulty during daily activities, higher levels indicate more severe symptoms |
| Short Form-36 (SF-36) | Changes from baseline (week 0) to the three WBV frequency conditions (weeks 1-3) and the cumulative effects after three additional sessions at the final randomized frequency (week 6) will be assessed. | The short form-36 (SF-36) measures physical and social health status, with higher scores representing better overall health |
Countries
Taiwan
Contacts
Department of Physical Therapy, National Cheng Kung University