Patients Following Lung Transplantation (Single and Double)NCT01480960
Effects of a Whole Body Vibration Training in Patients After Lung Transplantation
A study testing Pulmonary rehabilitation + whole body vibration training in people with Patients Following Lung Transplantation (Single and Double), run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Following Lung Transplantation (Single and Double)
- What is being tested?
- Pulmonary rehabilitation + whole body vibration training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participation in an inpatient rehabilitation program
- double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease
Who cannot join
- severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids
- non-compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation
Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients < 1 year after lung Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).
- Being tested
- Pulmonary rehabilitation + whole body vibration training
- Keywords
- lung transplantation, whole body vibration, exercise training, pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation + whole body vibration trainingOther
Also called Galileo training
standard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration training | Active comparator | Whole body vibration training in addition to pulmonary rehabilitation Receives: Other: Pulmonary rehabilitation + whole body vibration training |
| No whole body vibration training | No intervention | Pulmonary rehabilitation without whole body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 6-minute walking distance
Measured: change from baseline to day 21
Secondary outcomes (7)
change in Wmax
maximum workload in incremental cycling test
Measured: change from baseline to day 21
change in Fmax
maximum isometric quadriceps force
Measured: change from baseline to day 21
change in fibre cross sectional area
cross sectional area of the M.rectus femoris, measured by ultrasound
Measured: change from baseline to day 21
change in chair rise time
chair rise test: to get from a sitting position to a standing, measuring the time for 5 repetitions
Measured: change from baseline to day 21
change in quality of life
SF-36 questionnaire and CRQ questionnaire
Measured: change from baseline to day 21
change in body cell mass
measured by bio-impedance analysis
Measured: change from baseline to day 21
change in IGF-1
IGF-1, measured in a blood sample
Measured: change from baseline to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Following Lung Transplantation (Single and Double)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480960
- Sponsor's protocol ID
- LTX2011
- Status last verified
- Feb 2016
- First submitted
- 24 Nov 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.
PubMed 34282853
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation
- ClinicalTrials.gov ID
- NCT01480960
- Acronym / sponsor ID
- LTX2011
- Keywords
- lung transplantation, whole body vibration, exercise training, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients < 1 year after lung Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration training | Active comparator | Other: Pulmonary rehabilitation + whole body vibration trainingWhole body vibration training in addition to pulmonary rehabilitation |
| No whole body vibration training | No intervention | –Pulmonary rehabilitation without whole body vibration training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participation in an inpatient rehabilitation program
- double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease
Key exclusion criteria (2 listed)
- severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids
- non-compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation + whole body vibration trainingAlso: Galileo trainingstandard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week | Other | Whole body vibration training |
Primary outcome
change in 6-minute walking distance
Time frame: change from baseline to day 21
7 secondary outcomes
change in Wmax
Time frame: change from baseline to day 21
change in Fmax
Time frame: change from baseline to day 21
change in fibre cross sectional area
Time frame: change from baseline to day 21
change in chair rise time
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 IGF-1
Time frame: change from baseline to day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Derived from this study: PubMed 34282853Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation + whole body vibration training in people with Patients Following Lung Transplantation (Single and Double), run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in 6-minute walking distance (time frame: change from baseline to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.