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Completed

NCT Number: NCT02679677

Evaluation of the Effects of Whole Body Vibration on the Lung Function of Patients With Stable COPD

The typical clinical progression of COPD usually results in a decreased level of tolerable physical exertion for the patient. The avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. Recent research has shown that whole body vibration has the potential to improve physical fitness of participants, including such measures as the 6 minute walking distance. However, information concerning lung function is lacking.

The goal of the study is to test whether the use of whole body vibration training has an effect on the lung function of patients with stable COPD, or if the previously observed effects can be attributed to either pharmaceutical therapy or physical therapy interventions.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stable COPD (Gold II-IV)
  • Signed understanding of participation
  • The patients must be able to understand and follow the requirements of participation (Understanding of the German language)

Exclusion criteria

  • Acute thrombosis
  • Hemoptysis
  • Implants in the targeted training regions (joint implants)
  • Acute joint inflammation, active arthrosis or arthropathy.
  • Rheumatoid arthritis
  • Acute tendinopathy in the targeted training regions
  • Acute hernia
  • Acute discopathy
  • Fresh fracture in the targeted training regions
  • Gall or kidney stones
  • Wounds still in the process of healing
  • Epilepsy
  • Severe neurologic disorders (apoplexy, paralysis of upper and lower extremities)
  • Severe circulatory disorders (Cardiac insufficiency NYHA > or = III, myocardial infarct less than one month prior, circulatory relevant rhythm disorders, idiopathic syncope)
  • Tension pneumothorax
  • Acute internal bleeding
  • Current therapy with fluoroquinolone
  • Alcohol/drug/medication abuse

Treatment and study plan

Whole Body Vibration

Device

The principle of the Galileo vibration platform is a side alternating motion similar to a childrens seesaw. Both the amplitude of movement and the frequency of movement may be altered. Frequency may be controlled on the device and settings range from 5Hz to 30Hz. Amplitude of movement is set by spreading one's legs further apart from the midline. Control arm participants remain fixed at 5Hz through the 6 week training period, while intervention arm participants steadily increase their frequency to a maximum of 28Hz.

Other names: Galileo, Galileo Platform Novotec Medical

Primary outcomes

  1. FEV1

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

Secondary outcomes

  1. SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  2. mMRC: Modified British Medical Research Council

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  3. CAT: COPD Assessment Test

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  4. PHQ-9 (Brief Patient Health Questionnaire

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  5. SF-12: Short Form (12) Health Questionnaire

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  6. 6 Minute Walking Test

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  7. Chair Rising Test

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  8. Handheld Dynamometry Strength Testing of Extremities

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  9. Diffusion capacity for oxygen

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

  10. Maximal inspiratory pressure

    Time frame: Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2)

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • National Center for Tumor Diseases, Heidelberg

Registry information

Official study title

Evaluation of the Effects of Whole Body Vibration Training With the Galileo Training Device on the Lung Function of Patients With Stable COPD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2016
Registry last updated
Sep 2, 2022

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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