The Effects of Different Vibration Exercises on COPD Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413524
• Other study ID #: N202403010
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 21, 2024
• Est. completion date: June 13, 2025

Study information

• Verified date: May 2024
• Source: Taipei Medical University
• Contact: Yu-Huei Lin, Associate professor
• Phone: 0227361661
• Email: gracelin[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: June 13, 2025
• Est. primary completion date: April 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• COPD Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Vibration Therapy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University WanFang Hospital	Taipei City	Wenshan Dist

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Berner K, Albertyn SCS, Dawnarain S, Hendricks LJ, Johnson J, Landman A, Burger M. The effectiveness of combined lower limb strengthening and whole-body vibration, compared to strengthening alone, for improving patient-centred outcomes in adults with COPD — View Citation

DadeMatthews OO, Agostinelli PJ, Neal FK, Oladipupo SO, Hirschhorn RM, Wilson AE, Sefton JM. Systematic review and meta-analyses on the effects of whole-body vibration on bone health. Complement Ther Med. 2022 May;65:102811. doi: 10.1016/j.ctim.2022.10281 — View Citation

Djibo DA, Goldstein J, Ford JG. Prevalence of disability among adults with chronic obstructive pulmonary disease, Behavioral Risk Factor Surveillance System 2016-2017. PLoS One. 2020 Feb 27;15(2):e0229404. doi: 10.1371/journal.pone.0229404. eCollection 20 — View Citation

Gupta N, Pinto LM, Morogan A, Bourbeau J. The COPD assessment test: a systematic review. Eur Respir J. 2014 Oct;44(4):873-84. doi: 10.1183/09031936.00025214. Epub 2014 Jul 3. — View Citation

Iodice P, Bellomo RG, Gialluca G, Fano G, Saggini R. Acute and cumulative effects of focused high-frequency vibrations on the endocrine system and muscle strength. Eur J Appl Physiol. 2011 Jun;111(6):897-904. doi: 10.1007/s00421-010-1677-2. Epub 2010 Nov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walking Test		Base line, Week12, Week16
Primary	Maximal voluntary contraction force		Base line, Week12, Week16
Secondary	Five Times Sit to Stand Test (FTSST)		Base line, Week12, Week16
Secondary	Clinical COPD Questionnaire score, CCQ		Base line, Week12, Week16
Secondary	COPD assessment Test, CAT		Base line, Week12, Week16
Secondary	mMRC dyspnea scale, mMRC		Base line, Week12, Week16