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

Официальное название

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)

Обзор

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.

Вмешательства

• Поведенческое Whole body vibration
  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.

Первичные конечные точки

• Pulmonary function test [Срок оценки: 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 and thickness [Срок оценки: 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 [Срок оценки: 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.]
• cardiopulmonary response [Срок оценки: 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.]

Вторичные конечные точки (12)

• Upper limb muscle strength [Срок оценки: 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.]
• Handgrip strength [Срок оценки: 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.]
• Upper limb flexibility [Срок оценки: 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 (Standard Deviation of Normal-to Normal intervals, SDNN) [Срок оценки: 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 (Root mean square of successive differences, RMSSD) [Срок оценки: 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 (Low frequency, LF) [Срок оценки: 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 (High frequency power, HF) [Срок оценки: 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 (LF/HF ratio) [Срок оценки: 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.]
• St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: 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.]
• COPD Assessment Test (CAT) [Срок оценки: 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.]
• Fatigue Severity Scale (FSS) [Срок оценки: 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.]
• Modified Medical Research Council (mMRC) [Срок оценки: 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.]

Критерии участия

Healthy individuals

Критерии включения

• No prior experience with whole-body vibration therapy or exposure to vibration-related occupations or sports.
• Aged between 18 and 65 years.

Критерии исключения

• 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

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• National Cheng Kung University Hospital — Tainan

Идентификаторы

NCT: NCT07509606 · A-ER-114-109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗