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Completed

NCT Number: NCT04952363

Whole-body Vibration on Mucus Clearance, the Quality of Life, and Exercise Capacity for Patients With Chronic Obstructive Pulmonary Disease

Although whole body vibration (WBV) is mainly designed to promote neuromuscular function, however, because of its vibration characteristics, whether it can provide additional effects on the sputum clearance for chronic obstructive pulmonary (COPD) disease patients, thereby improving the quality of life, and exercise capacity is still unknown.

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Key information

Conditions

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

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of COPD at the outpatient thoracic medicine clinic
  • Need HFCWO as judged by the doctor

Exclusion criteria

  • Acute COPD exacerbation within the previous 4 weeks,
  • Contraindication for WBVT (e.g., artificial joint replacement, a history of deep vein thrombosis, or known aortic aneurysm)
  • Inability to perform squatting exercises
  • Acute disc disease
  • Inability to complete the 6MWT

Treatment and study plan

A vertical vibration platform PowerVibe Zen Pro 5900

Device

Subjects received the interventions twice a week for 8 weeks. HFCWO+WBVT group received additional 30 minutes WBVT treatment. In every WBVT session, three rounds of 3 minutes of vibration (amplitude: 2 mm; frequency: 20 Hz) were provided, with a 60-second rest between rounds.

HFCWO

Device

Subjects received the interventions twice a week for 8 weeks. The HFCWO was delivered by a respiratory therapist using a percussive vest at 10-13 Hz oscillating frequency and at a pressure setting of 2 cm H2O. The treatment duration was 25 minutes, and the participants remained in a sitting position.

Primary outcomes

  1. FVC

    Time frame: 8 weeks

    forced vital capacity tested in pulmonary function test (Liters)

  2. FEV1

    Time frame: 8 weeks

    forced expiratory volume in 1 second in pulmonary function test (Liters)

  3. FEV1/FVC

    Time frame: 8 weeks

    forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test (%)

  4. FVC(% pred)

    Time frame: 8 weeks

    percentage of predicted FVC value (% pred)

  5. FEV1(% pred)

    Time frame: 8 weeks

    percentage of predicted FEV1 value (% pred)

  6. 6 min walk distance

    Time frame: 8 weeks

    the distance walked in 6 minutes (m)

  7. Predicted distance

    Time frame: 8 weeks

    percentage of the predicted 6 minute walk test distance (%pred)

  8. Distance-Saturation Product (DSP)

    Time frame: 8 weeks

    the product of distance walked and lowest oxygen saturation during the 6-min walk test (m%)

  9. 1 min STST

    Time frame: 8 weeks

    the number of repetitions performed in the 1-min sit-to-stand test (rep.)

  10. 5-rep STST

    Time frame: 8 weeks

    the complete time for the 5-repetition sit-to-stand test (sec)

  11. Muscle strength test1

    Time frame: 8 weeks

    Maximal force output for biceps femoris muscle (lbs)

  12. Muscle strength test2

    Time frame: 8 weeks

    maximal force output for quadriceps muscle (lbs)

  13. Sputum self-assessment scale

    Time frame: 8 weeks

    questionnaire of sputum volume, it contained three items (0-25 mL/d, 25-50 mL/d, and 50-100 mL/d) as a checklist

  14. X-ray score

    Time frame: 8 weeks

    the evaluation of the chest radiography based on the sputum impaction score, scores ranging from 0 to 18. A decrease in score represented an improvement in sputum in each area.

  15. modified Medical Research Council (mMRC)

    Time frame: 8 weeks

    questionnaire of dyspnea, scores ranging from 0 (low degree of dyspnea) to 4 (high degree of dyspnea)

  16. chronic obstructive pulmonary disease assessment test (CAT)

    Time frame: 8 weeks

    questionnaire of COPD symptoms, scores ranging from 0 to 40, higher scores indicating more severe impact of COPD on their life

  17. Saint George Respiratory Questionnaire (SGRQ)

    Time frame: 8 weeks

    questionnaire of overall health, daily life, and perceived well-being, scores ranging from 0 (no health impairment) to 100 (maximum health impairment)

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

The Effect of Whole Body Vibration Training on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2021
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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