Idiopathic Pulmonary FibrosisNCT01772667
Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis
A study testing Inpatient Rehabilitation in people with Idiopathic Pulmonary Fibrosis, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there are no data available regarding long-term effects of this multimodal program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Inpatient Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Oct 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- want to start a rehabilitation program in "Schoen Klinik Berchtesgadener Land"
- patients with idiopathic pulmonary fibrosis (vital capacity > 50% pred.)
Who cannot join
- exacerbation in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471
About this study
Official title: Long Term Effects of a 3-week Inpatient Pulmonary Rehabilitation Program in Patients With Idiopathic Pulmonary Fibrosis
There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there are no data available regarding long-term effects of this multimodal program. The aim of this study is to investigate the long-term impact of a rehabilitation program 3 month after finishing on exercise capacity and physical activity.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Inpatient Rehabilitation
- Keywords
- pulmonary fibrosis, interstitial lung disease, pulmonary rehabilitation, exercise capacity, physical activity, quality of life
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient RehabilitationProcedure or surgery
Rehabilitation program in "Schoen Klinik Berchtesgadener Land"
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care during the whole study period without pulmonary rehabilitation. The patients will perform their normal daily life. |
| Inpatient Rehabilitation | Active comparator | 3-week inpatient multimodal pulmonary rehabilitation program, including daily exercise training, breathing therapy, medical treatment and psychological support. In the following 3 month, the patients will perform their normal daily life. Receives: Procedure: Inpatient Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta of 6-minute walking distance from 1 week pre rehabilitation to 3 month post rehabilitation
Measured: 1 week before rehabilitation to 3 month after finishing rehabilitation
Secondary outcomes (2)
Delta of physical activity level from 1 week pre rehabilitation to 3 month post rehabilitation
Measured: 1 week before rehabilitation to 3 month after finishing rehabilitation
Delta of SF36-score (questionnaire to measure quality of life) from 1 week pre to 3 month post rehabilitation
Measured: 1 week before rehabilitation to 3 month after finishing rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 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
- Investigators
- Klaus Kenn, MD, Study director, Head physician in the department of pulmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772667
- Sponsor's protocol ID
- Fibrosis2013
- Status last verified
- Sep 2020
- First submitted
- 17 Jan 2013
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of a 3-week Inpatient Pulmonary Rehabilitation Program in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT01772667
- Acronym / sponsor ID
- Fibrosis2013
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- pulmonary fibrosis, interstitial lung disease, pulmonary rehabilitation, exercise capacity, physical activity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Jan 2013 (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.
There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there are no data available regarding long-term effects of this multimodal program. The aim of this study is to investigate the long-term impact of a rehabilitation program 3 month after finishing on exercise capacity and physical activity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care during the whole study period without pulmonary rehabilitation. The patients will perform their normal daily life. |
| Inpatient Rehabilitation | Active comparator | Procedure: Inpatient Rehabilitation3-week inpatient multimodal pulmonary rehabilitation program, including daily exercise training, breathing therapy, medical treatment and psychological support. In the following 3 month, the patients will perform their normal daily life. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- want to start a rehabilitation program in "Schoen Klinik Berchtesgadener Land"
- patients with idiopathic pulmonary fibrosis (vital capacity > 50% pred.)
Key exclusion criteria (1 listed)
- exacerbation in the last 4 weeks
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 |
|---|---|---|
| Inpatient RehabilitationRehabilitation program in "Schoen Klinik Berchtesgadener Land" | Procedure or surgery | Inpatient Rehabilitation |
Primary outcome
Delta of 6-minute walking distance from 1 week pre rehabilitation to 3 month post rehabilitation
Time frame: 1 week before rehabilitation to 3 month after finishing rehabilitation
2 secondary outcomes
Delta of physical activity level from 1 week pre rehabilitation to 3 month post rehabilitation
Time frame: 1 week before rehabilitation to 3 month after finishing rehabilitation
Delta of SF36-score (questionnaire to measure quality of life) from 1 week pre to 3 month post rehabilitation
Time frame: 1 week before rehabilitation to 3 month after finishing rehabilitation
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 4 Sep 2020.
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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.
Klaus Kenn, MD study director
Head physician in the department of pulmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient Rehabilitation in people with Idiopathic Pulmonary Fibrosis, 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 1 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 4 Sep 2020. 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?
Delta of 6-minute walking distance from 1 week pre rehabilitation to 3 month post rehabilitation (time frame: 1 week before rehabilitation to 3 month after finishing rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2020.