Pulmonary EmbolismPURE-PENCT04615130
PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome
A study testing Rehabilitation in people with Pulmonary Embolism, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism. Patients will be randomized into an intervention and a control group. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:
- Post-PE functional impairment criteria
- Post-PE Cardiac Impairment criteria
- Chronic Thromboembolic Disease criteria
- Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE
Who cannot join
- CTEPH diagnosis
- Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
- Active cancer
- Pregnancy
- Myocardial infarction or cardiac surgery one year prior to inclusion
- Congenital heart disease, congestive heart failure
Show all 17Show fewer
- History of stroke
- Any previous inpatient or outpatient PR
- Additional criteria that are absolute contraindications for pulmonary rehabilitation
- Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders)
- open tuberculosis
- active infectious diseases and acute inflammatory processes
- Stressful and time-consuming therapy that significantly impair the ability to rehabilitate (e.g. chemotherapy or radiation therapy after malignancy)
- Participants who are not sufficiently resilient due to physical or mental impairment and / or cannot be mobilized and therefore cannot actively use the rehabilitation facility
- lack of motivation for therapy
- massive incontinence
- drugs and alcohol addiction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study
This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism.
Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.
- Conditions
- Pulmonary Embolism
- Being tested
- Rehabilitation
- Keywords
- Pulmonary Rehabilitation, Exercise Training, Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Rehabilitation, exercise training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will undergo 6 weeks of outpatient rehabilitation. Receives: Other: Rehabilitation |
| Control | No intervention | Patients will receive no intervention throughout the 6 weeks period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test
change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters
Measured: within the 6-week study period
Secondary outcomes (12)
peak oxygen consumption
change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry
Measured: within the 6-week study period
Maximal workload
change of maximal workload in cycle ergometer tests measured in Watt
Measured: within the 6-week study period
One-repetition maximum for lower extremities
change of one-repetition maximum for lower extremities measured in kg
Measured: within the 6-week study period
One-repetition maximum for upper extremities
change of one-repetition maximum for upper extremities measured in kg
Measured: within the 6-week study period
Maximal inspiratory muscle pressure
change in maximum inspiratory muscle pressure measured in mbar
Measured: within the 6-week study period
Inspiratory muscle endurance
change in inspiratory muscle endurance measured in seconds
Measured: within the 6-week study period
Level of dyspnea
change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale
Measured: within the 6-week study period
Health related quality of life
change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L)
Measured: within the 6-week study period
Disease related quality of life
change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL)
Measured: within the 6-week study period
Functional limitations
change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form
Measured: within the 6-week study period
Functional status
change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status)
Measured: within the 6-week study period
Anxiety and depression
change in anxiety and depression measured with the hospital anxiety and depression scale (HADS)
Measured: within the 6-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Nopp, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615130
- Sponsor's protocol ID
- 1335/2020
- Acronym
- PURE-PE
- Status last verified
- Sep 2025
- First submitted
- 22 Oct 2020
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789.
PubMed 34127618
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study
- ClinicalTrials.gov ID
- NCT04615130
- Acronym / sponsor ID
- PURE-PE / 1335/2020
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Rehabilitation, Exercise Training, Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 2020 (actual)
- 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.
This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism.
Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: RehabilitationPatients will undergo 6 weeks of outpatient rehabilitation. |
| Control | No intervention | –Patients will receive no intervention throughout the 6 weeks period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:
- Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE
Key exclusion criteria (17 listed)
- CTEPH diagnosis
- Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
- Active cancer
- Pregnancy
- Myocardial infarction or cardiac surgery one year prior to inclusion
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 |
|---|---|---|
| RehabilitationRehabilitation, exercise training | Other | Intervention |
Primary outcome
6-Minute Walk Test
Time frame: within the 6-week study period
change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters
12 secondary outcomes
peak oxygen consumption
Time frame: within the 6-week study period
Maximal workload
Time frame: within the 6-week study period
One-repetition maximum for lower extremities
Time frame: within the 6-week study period
One-repetition maximum for upper extremities
Time frame: within the 6-week study period
Maximal inspiratory muscle pressure
Time frame: within the 6-week study period
Inspiratory muscle endurance
Time frame: within the 6-week study period
Level of dyspnea
Time frame: within the 6-week study period
Health related quality of life
Time frame: within the 6-week study period
Disease related quality of life
Time frame: within the 6-week study period
Functional limitations
Time frame: within the 6-week study period
Functional status
Time frame: within the 6-week study period
Anxiety and depression
Time frame: within the 6-week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 34127618Fabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Pulmonary Embolism, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 26 Sep 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Nopp, Dr. (+43 40400 44170, stephan.nopp@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (time frame: within the 6-week study period). 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 NCT04615130, 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 26 Sep 2025.