The Effects of Different Vibration Exercises on COPD Patients

Not Applicable

Recruiting

• Conditions: COPD; COPD Chronic Obstructive Pulmonary Disease; Vibration Therapy
• Interventions: Device: Sham Comparator; Device: Whole-body Vibration Therapy; Device: Local Vibration Therapy

• Registration Number: NCT06413524
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-14
• Study Start: 2024-08-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-04-21
• Study Completion: 2025-06-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Sham Comparator	-
Whole-body Vibration Training Group	Whole-body Vibration Therapy	-
Local Vibration Training Group	Local Vibration Therapy	-

Primary Outcome Measures

Name	Time	Method
6 Minute Walking Test	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	Base line, Week12, Week16	The readings from the digital dynamometer can be converted into kilograms, with higher values indicating greater muscle strength.

Secondary Outcome Measures

Name	Time	Method
Five Times Sit to Stand Test (FTSST)	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.
Clinical COPD Questionnaire score, CCQ	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.
COPD assessment Test, CAT	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.
mMRC dyspnea scale, mMRC	Base line, Week12, Week16	The scale ranges from 0 to 4, with higher scores representing more severe conditions.

Trial Locations

Locations (1)

Taipei Medical University WanFang Hospital; 🇨🇳 Taipei City, Wenshan Dist, Taiwan