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NCT Number: NCT06413524

The Effects of Different Vibration Exercises on COPD Patients

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.

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Key information

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University WanFang Hospital

Taipei, Wenshan Dist, 116, Taiwan

Location status: Recruiting

Location contact

XUANYU LIAO, Master student

CONTACT

[email protected]

0229307930 ext. 2968

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • Clear consciousness, normal cognitive function, and ability to communicate in Mandarin or Taiwanese for understanding experimental procedures and relevant instructions.

Exclusion criteria

  • 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.

Treatment and study plan

Whole-body Vibration Therapy

Device

Each 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

Device

Each 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.

Primary outcomes

  1. 6 Minute Walking Test

    Time frame: Base line, Week12, Week16

    This test measures how far the patient can walk in 6 minutes, with a greater distance indicating better performance.

  2. Maximal voluntary contraction force

    Time frame: Base line, Week12, Week16

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

Secondary outcomes

  1. Five Times Sit to Stand Test (FTSST)

    Time frame: Base line, Week12, Week16

    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.

  2. Clinical COPD Questionnaire score, CCQ

    Time frame: Base line, Week12, Week16

    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.

  3. COPD assessment Test, CAT

    Time frame: Base line, Week12, Week16

    CAT has a scoring range of zero to 40; higher scores indicate a greater severity of COPD's impact on a patient's life.

  4. mMRC dyspnea scale, mMRC

    Time frame: Base line, Week12, Week16

    The scale ranges from 0 to 4, with higher scores representing more severe conditions.

Study contacts

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

Yu-Huei Lin, Associate professor

CONTACT

[email protected]

0227361661 ext. 3620

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • Taipei Medical University WanFang Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 14, 2024
Registry last updated
Jan 16, 2025

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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