Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Aim of this study is to compare the effects of whole-body Vibration Training versus conventional Balance Training on Balance performance, gait quality and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. On top of a standardized endurance and strength Training program (5 days per week) patients in both groups will perform an additional Balance Training (on 3 days per week). Patients in both Groups will perform the same 4 different Balance exercises (2x1 Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg stance but on a different surface. The Vibration Training Group will perform the exercises on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the control Group will perform exercises on instable objects like Balance pads. The degree of difficulty in both Groups will be individually adjusted and will be progressively increased, if possible.

Official Title
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Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Balance Training on a vibration platform
* Other: Conventional Balance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD stage III or IV according to the global initiative for chronic obstructive lung disease impaired exercise capacity (6 Minute walk distance of less than 70% of the reference value from Troosters et al.) Exclusion Criteria: current acute exacerbation of COPD carbon dioxide pressure of more than 45 mmHg at rest any contraindication for vibration Training (e.g. acute deep vein thrombosis)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole Body Vibration training<br>Balance Training on a Vibration platform | Other: Balance Training on a vibration platform<br>* n=24 patients with severe chronic obstructive pulmonary disease. Exercises will be performed on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz.<br>|
| Active Comparator: Conventional Balance training<br>Balance Training on a Balance board | Other: Conventional Balance training<br>* n=24 patients with COPD, Exercises will be performed on a Balance pad<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Balance Performance during semi Tandem stance | patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force. | measurement on Day 1 and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle power during counter movement jump | patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight | measurement on Day 1 and 21 | 
| Change in performance of the 5-Repetition-Raise-Test | Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible | measurement on Day 1 and 21 | 
| Change in performance of the 1-Minute-Chair-Rise-Test | Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute | measurement on Day 1 and 21 | 
| Change in Peak muscle strength of the knee Extension muscles | isometric peak torque of the knee extensor muscles are measured in 90° knee angle | measurement on Day 1 and 21 | 
| Change in Peak muscle strength of the knee Flexion muscles | isometric peak torque of the knee flexor muscles are measured in 90° knee angle | measurement on Day 1 and 21 | 
| Change in 6-minute Walk Distance | patients are advised to walk as far as possible on a 30m track | measurement on Day 1 and 21 | 
| Change in 4m Gait Speed Test | patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk. | measurement on Day 1 and 21 | 
| Change in step symmetry during 20m walking | Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis | measurement on Day 1 and 21 | 
| Change in Hospital anxiety and Depression scale | the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression | measurement on Day 1 and 21 | 
| Change in balance performance during Romberg stance | patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force. | measurement on Day 1 and 21 | 
| Change in Balance Performance during 1-leg stance | patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force. | measurement on Day 1 and 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Balance, Whole Body Vibration Training, pulmonary rehabilitation, exercise