The Effects of Different Vibration Exercises on COPD Patients

May 9, 2024 updated by: Taipei Medical University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yu-Huei Lin, Associate professor
  • Phone Number: 3620 0227361661
  • Email: gracelin@tmu.edu.tw

Study Locations

  • Taiwan
    • Wenshan Dist
      • Taipei City, Wenshan Dist, Taiwan, 116
        • Taipei Medical University WanFang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 40.
  2. Diagnosis of chronic obstructive pulmonary disease (COPD) based on the criteria established by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
  3. 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.
  4. Willingness to participate in vibration exercise intervention and ability to comply with the study activities, including signing the informed consent form.
  5. Clear consciousness, normal cognitive function, and ability to communicate in Mandarin or Taiwanese for understanding experimental procedures and relevant instructions.

Exclusion Criteria:

  1. 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.
  2. The interval since the last pulmonary rehabilitation is less than three months.
  3. 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.
  4. 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.
  5. Underwent lower limb-related surgery within the past year or is in the recovery period post-surgery.
  6. Currently diagnosed with cancer or undergoing cancer treatment.
  7. Participation in other research studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control Group
Device: Sham Comparator
Patients are instructed to perform squatting and standing exercises at home without vibration equipment. Health education is provided at the time of enrollment, and patients are instructed to perform the exercises twice a week at home, with follow-up via telephone to check compliance. Each session consists of 10 minutes of warm-up exercises for the upper limbs, lower limbs, and spine, six sets of squatting and standing exercises, and a final 10-minute stretching exercise. Each session includes six series, each lasting 2 minutes, with a 60-second rest interval between series. After the warm-up exercises, participants should hold onto large household furniture or walls and squat and stand at a steady pace until the two minutes are up.
Experimental: Whole-body Vibration Training Group
Device: Whole-body Vibration Therapy
Each session consists of 10 minutes of warm-up exercises for the upper limbs, lower limbs, and spine, six sets of vibration training, and 10 minutes of stretching exercises at the end. 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. After vibration starts, the patient squat and stand at a steady pace until the two minutes are over.
Experimental: Local Vibration Training Group
Device: Local Vibration Therapy
Each session consists of 10 minutes of warm-up exercises for the upper limbs, lower limbs, and spine, six sets of vibration training, and a final 10-minute stretching exercise. 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. After the vibration begins, the patient squat and stand at a steady pace until the two minutes are over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 Minute Walking Test
Time Frame: Base line, Week12, Week16
Base line, Week12, Week16
Maximal voluntary contraction force
Time Frame: Base line, Week12, Week16
Base line, Week12, Week16

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Collaborators

Taipei Medical University WanFang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 21, 2024

Primary Completion (Estimated)

April 21, 2025

Study Completion (Estimated)

June 13, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202403010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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