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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: Whole Body Vibration

• Registration Number: NCT02679677
• Lead Sponsor: Heidelberg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-02-07
• Study First Posted: 2016-02-10
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Whole Body Vibration	Whole body vibration training (12 Hz up to 30 Hz) 3 times a week, 3x2 minutes, for 6 weeks.
Control	Whole Body Vibration	Whole body vibration training as sham procedure (5Hz) 3 times a week, 3x2 minutes, for 6 weeks.

Primary Outcome Measures

Name	Time	Method
FEV1	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 Outcome Measures

Name	Time	Method
SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients	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)
Maximal inspiratory pressure	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)
Handheld Dynamometry Strength Testing of Extremities	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)
Diffusion capacity for oxygen	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)
SF-12: Short Form (12) Health Questionnaire	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)
CAT: COPD Assessment Test	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)
mMRC: Modified British Medical Research Council	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 Minute Walking Test	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)
Chair Rising Test	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)
PHQ-9 (Brief Patient Health Questionnaire	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)

Trial Locations

Locations (2)

Thoraxklinik at Heidelberg University Hospital; 🇩🇪 Heidelberg, Germany

University Clinic Gießen and Marburg GmbH, Marburg Campus; 🇩🇪 Marburg, Germany