The Effects of Different Vibration Exercises on COPD Patients

NCT06413524 | Recruiting

• 1 other identifier: N202403010
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; COPD Chronic Obstructive Pulmonary Disease; Vibration Therapy

Outcome Measures

Primary Outcomes (2)

• 6 Minute Walking Test

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

  Base line, Week12, Week16

• Maximal voluntary contraction force

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

  Base line, Week12, Week16

Secondary Outcomes (4)

• 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

Study Arms (3)

Whole-body Vibration Training Group

EXPERIMENTAL

Receive whole-body vibration twice a week for 12 weeks.

Device: Whole-body Vibration Therapy

Local Vibration Training Group

EXPERIMENTAL

Receive local vibration twice a week for 12 weeks.

Device: Local Vibration Therapy

Control Group

NO INTERVENTION

Receive no intervention

Interventions

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.

Whole-body Vibration Training Group

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.

Local Vibration Training Group

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead
• Taipei Medical University WanFang Hospital: collaborator

Study Sites (1)

Taipei Medical University WanFang Hospital

Taipei, Wenshan Dist, 116, Taiwan

RECRUITING

Related Publications (5)

• 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.2022.102811. Epub 2022 Jan 29.

  PMID: 35093509 BACKGROUND

• 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 10.

  PMID: 21063726 BACKGROUND

• 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.

  PMID: 24993906 BACKGROUND

• 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 2020.

  PMID: 32106254 BACKGROUND

• 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: A systematic review. S Afr J Physiother. 2020 Jun 11;76(1):1412. doi: 10.4102/sajp.v76i1.1412. eCollection 2020.

  PMID: 32671277 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu-Huei Lin, Associate professor

CONTACT

0227361661; gracelin@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: August 8, 2024
• Primary Completion: April 21, 2025
• Study Completion: June 13, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)