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临床试验/NCT06413524
NCT06413524招募中不适用

The Effects of Different Vibration Exercises on the Strength of Lower Extremity Muscles, Exercise Endurance, and Quality of Life Among COPD Patients

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
2
主要终点
6 Minute Walking Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

6 Minute Walking Test

时间窗: 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

时间窗: Base line, Week12, Week16

The readings from the digital dynamometer can be converted into kilograms, with higher values indicating greater muscle strength.

次要结局

  • Five Times Sit to Stand Test (FTSST)(Base line, Week12, Week16)
  • Clinical COPD Questionnaire score, CCQ(Base line, Week12, Week16)
  • COPD assessment Test, CAT(Base line, Week12, Week16)
  • mMRC dyspnea scale, mMRC(Base line, Week12, Week16)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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