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NCT Number: NCT07509606

Acute Effect of Different Frequency of Whole Body Vibration (WBV) on Healthy and Chronic Obstructive Pulmonary Disease (COPD)

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Whole Body Vibration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 701, Taiwan

Location status: Recruiting

Location contact

Kun-Ling Tasi, PhD

CONTACT

[email protected]

062353535 Ext. 6219

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Severe respiratory diseases (e.g., bronchiectasis, pulmonary fibrosis, asthma, or tuberculosis).
  • Current smokers.
  • Hip or knee implants.
  • Severe joint disease or history of lower extremity surgery.
  • History of vitreous hemorrhage.
  • Dependence on supplemental oxygen.
  • Severe alcohol abuse (>80 g/day).
  • Severe malnutrition (BMI < 19 kg/m²).
  • Pregnancy.
  • Acute thrombosis.
  • Presence of a cardiac pacemaker.
  • Recent wounds due to injury or surgery.
  • 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.
  • Altered consciousness or inability to comply with assessments.
  • Participation in other research studies concurrently

Treatment and study plan

Whole Body Vibration

Behavioral

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.

Primary outcomes

  1. Pulmonary function test

    Time frame: 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.

  2. Diaphragm excursion and thickness

    Time frame: 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.

  3. Respiratory muscle strength

    Time frame: 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

  4. cardiopulmonary response

    Time frame: 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 outcomes

  1. Upper limb muscle strength

    Time frame: 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)

  2. Handgrip strength

    Time frame: 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)

  3. Upper limb flexibility

    Time frame: 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)

  4. Heart rate variability (Standard Deviation of Normal-to Normal intervals, SDNN)

    Time frame: 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

  5. Heart rate variability (Root mean square of successive differences, RMSSD)

    Time frame: 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

  6. Heart rate variability (Low frequency, LF)

    Time frame: 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.

  7. Heart rate variability (High frequency power, HF)

    Time frame: 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.

  8. Heart rate variability (LF/HF ratio)

    Time frame: 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.

  9. St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 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.

  10. COPD Assessment Test (CAT)

    Time frame: 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.

  11. Fatigue Severity Scale (FSS)

    Time frame: 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.

  12. Modified Medical Research Council (mMRC)

    Time frame: 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

  13. Short Form-36 (SF-36)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kun-Ling Tasi, PhD

CONTACT

[email protected]

886-6-2353535 Ext.5078

Ting-Ying Wu, B.S

CONTACT

[email protected]

886-6-2353535 Ext.5078

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

Acute Effect of Different Frequency of Whole Body Vibration (WBV) on Lung Function, Respiratory Function, Upper Extremity Strength and Flexibility, Cardiac Automatic Function and Quality of Life in Healthy and Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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