Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD III/IV, 6-Minutes-Walking-Distance, Vibration training, Galileo, Pulmonary rehabilitation
Brief summary
The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program.
Interventions
OTHERwhole body vibration training
performing squats for 3x3 minutes while using vibration platform three times a week
Sponsors
Schön Klinik Berchtesgadener Land
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic obstructive pulmonary disease III/IV
Exclusion criteria
* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics)) * Severe disease other than COPD, that could influence the results of the study * Abuse of alcohol or drugs * Simultaneously participation in another study * Tachypnea (\>30/min) * Severe exacerbation during rehabilitation * Cardiac insufficiency (NYHA IV) * Myocardial infarction during the last 6 weeks * Mental-health problem * Pregnancy * Known HIV-infection * Slipped disk * Acute discopathy * Acute thrombosis * Implants in trained regions of the body (lower extremities) * Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis * Acute tendinopathy in trained regions of the body * Acute hernia * Fresh fractures, wounds or scars in trained regions of the body * Gallstones or stones in the urinary tract collection system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute-Walking-Distance | day 1, day 19 | Change in 6-minute-walking-distance from baseline to day 19 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | day 1 and 19 | Change in body composition from baseline to day 19 |
| Isometric Maximum Handgrip Force | day 1, day 19 | change in isometric max. handgrip force from baseline to day 19 |
| Brain Natruretic Peptide (BNP) | day 1, day 19 | change in BNP from baseline to day 19 |
| Lung Function | day 1 | — |
| Arterial Blood Gas | day 1 | — |
| BODE-Score | day 1, day 19 | Change in Bode-Score from baseline to day 19 |
Countries
Germany
Participant flow
Pre-assignment details
Enrollment of patients is meant for the number of study completers without drop out patients (n=10).
Participants by arm
| Arm | Count |
|---|---|
| Rehabilitation With Vibration Training whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week | 42 |
| Rehabilitation Without Vibration Training | 40 |
| Total | 82 |
Baseline characteristics
| Characteristic | Rehabilitation Without Vibration Training | Rehabilitation With Vibration Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 20 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 22 Participants | 41 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 7 | 64 years STANDARD_DEVIATION 11 | 64 years STANDARD_DEVIATION 9 |
| Region of Enrollment Germany | 40 participants | 42 participants | 82 participants |
| Sex: Female, Male Female | 19 Participants | 23 Participants | 42 Participants |
| Sex: Female, Male Male | 21 Participants | 19 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 40 |
| other Total, other adverse events | 0 / 42 | 0 / 40 |
| serious Total, serious adverse events | 0 / 42 | 0 / 40 |
Outcome results
Primary
6-Minute-Walking-Distance
Change in 6-minute-walking-distance from baseline to day 19
Time frame: day 1, day 19
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation With Vibration Training | 6-Minute-Walking-Distance | 64 m | Standard Deviation 59 |
| Rehabilitation Without Vibration Training | 6-Minute-Walking-Distance | 37 m | Standard Deviation 52 |
Secondary
Arterial Blood Gas
Time frame: day 1
Secondary
BODE-Score
Change in Bode-Score from baseline to day 19
Time frame: day 1, day 19
Secondary
Body Composition
Change in body composition from baseline to day 19
Time frame: day 1 and 19
Secondary
Brain Natruretic Peptide (BNP)
change in BNP from baseline to day 19
Time frame: day 1, day 19
Secondary
Isometric Maximum Handgrip Force
change in isometric max. handgrip force from baseline to day 19
Time frame: day 1, day 19
Secondary
Lung Function
Time frame: day 1