|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
14 March 2016 |
|
Main ID: |
NCT01480960 |
|
Date of registration:
|
24/11/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effects of a Whole Body Vibration Training in Patients After Lung Transplantation
|
|
Scientific title:
|
Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation |
|
Date of first enrolment:
|
January 2012 |
|
Target sample size:
|
140 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01480960 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- participation in an inpatient rehabilitation program
- double or single lung transplantation due to chronic obstructive pulmonary disease,
Alpha-1-antitrypsine deficiency, interstitial lung disease
Exclusion Criteria:
- severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/
corticosteroids
- non-compliance
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Patients Following Lung Transplantation (Single and Double)
|
|
Intervention(s)
|
|
Other: Pulmonary rehabilitation + whole body vibration training
|
|
Primary Outcome(s)
|
|
change in 6-minute walking distance
[Time Frame: change from baseline to day 21]
|
|
Secondary Outcome(s)
|
|
change in fibre cross sectional area
[Time Frame: change from baseline to day 21]
|
|
change in quality of life
[Time Frame: change from baseline to day 21]
|
|
change in body cell mass
[Time Frame: change from baseline to day 21]
|
|
change in chair rise time
[Time Frame: change from baseline to day 21]
|
|
change in Fmax
[Time Frame: change from baseline to day 21]
|
|
change in IGF-1
[Time Frame: change from baseline to day 21]
|
|
change in Wmax
[Time Frame: change from baseline to day 21]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|