## Protocol Section
### Identification Module
**NCT ID:** NCT06413524

**Brief Title:** The Effects of Different Vibration Exercises on COPD Patients

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

#### Organization Study ID Info
**ID:** N202403010
#### Organization
**Class:** OTHER
**Full Name:** Taipei Medical University
### Status Module
#### Completion Date
**Date:** 2025-06-13

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-21

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Taipei Medical University WanFang Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Taipei Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- COPD

- COPD Chronic Obstructive Pulmonary Disease

- Vibration Therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 18

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Whole-body Vibration Therapy

**Label:** Whole-body Vibration Training Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Device: Local Vibration Therapy

**Label:** Local Vibration Training Group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Device: Sham Comparator

**Label:** Control Group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Whole-body Vibration Training Group

**Description:** 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.

**Name:** Whole-body Vibration Therapy

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Local Vibration Training Group

**Description:** 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.

**Name:** Local Vibration Therapy

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Control Group

**Description:** 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.

**Name:** Sham Comparator

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** 6 Minute Walking Test

**Time Frame:** Base line, Week12, Week16

**Measure:** Maximal voluntary contraction force

**Time Frame:** Base line, Week12, Week16

#### Secondary Outcomes

**Measure:** Five Times Sit to Stand Test (FTSST)

**Time Frame:** Base line, Week12, Week16

**Measure:** Clinical COPD Questionnaire score, CCQ

**Time Frame:** Base line, Week12, Week16

**Measure:** COPD assessment Test, CAT

**Time Frame:** Base line, Week12, Week16

**Measure:** mMRC dyspnea scale, mMRC

**Time Frame:** Base line, Week12, Week16

### Eligibility Module

**Eligibility Criteria:** 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 \&lt; 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.

**Maximum Age:** 99 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gracelin@tmu.edu.tw

**Name:** Yu-Huei Lin, Associate professor

**Phone:** 0227361661

**Phone Ext:** 3620

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Taipei City

**Contacts:**

***Contact 1:***

- **Email:** cherry85420@gmail.com

- **Name:** XUANYU LIAO, Master student

- **Phone:** 0229307930

- **Phone Ext:** 2968

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Taipei Medical University WanFang Hospital

**State:** Wenshan Dist

**Zip:** 116

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.2022.102811. Epub 2022 Jan 29.

**PMID:** 35093509

**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 10. Erratum In: Eur J Appl Physiol. 2013 Nov;113(11):2871.

**PMID:** 21063726

**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.

**PMID:** 24993906

**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 2020.

**PMID:** 32106254

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

- ID: D000008173

- Term: Lung Diseases, Obstructive

### Misc Info Module

- Version Holder: 2024-05-31
