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Pulmonary EmbolismNCT03405480

Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism

A study testing Rehabilitation in people with Pulmonary Embolism, run by Ostfold Hospital Trust at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Embolism Syndrome" (PPS). Read more about this study

Who is it for?
Ages 18 to 75 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
209 participants
Where
1 siteNorway
Study dates
20 Jan 2018to 30 Mar 2024
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

  • Objectively diagnosed symptomatic pulmonary embolism by CTPA or high-probability scintigraphy 6 months to 6 years before inclusion
  • Persistent dyspnea defined as modified Medical Research Council (mMRC) breathlessness scale >= 1 that has appeared or worsened after the diagnosis of PE (eligibility criteria for randomization)

Who cannot join

  • Significant pulmonary disease (COPD GOLD >= 2, restrictive pulmonary disease, lung cancer or pleural disease.
  • Heart failure (either HFrEF, HFmrEF or HFpEF as defined in ESC guidelines)
  • Significant valvular heart disease
  • Chronic thromboemboli pulmonary hypertension (CTEPH)
  • Patients unfit for rehabilitation or walking tests du to old age, physical disability or disease
  • Patients with a history of poor compliance or any condition that would interfere with the ability to comply with the study protocol e.g. history of drug abuse, excessive alcohol beverage consumption, cognitive dysfunction or severe psychiatric disease
Show all 9Show fewer
  • Active malignancy
  • Life expectancy less than 3 months
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • The hospital of Østfold, Kalnes

    Grålum, 1714

Other trials in Norway

About this study

Official title: Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism - a Randomized Controlled Trial - The REHAB Study

This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Embolism Syndrome" (PPS).

Read the detailed description

The newly identified Post Pulmonary Embolism Syndrome (PPS) is characterized by chronic persistent, but unexplained dyspnea (i.e. without signs of pulmonary hypertension or pulmonary abnormality). Symptoms are considerable, but less severe than in CTEPH patients. A recent study performed by our group confirmed that up to 50% of our patients complained of various grades of persistent unexplained dyspnea 1-10 years after the diagnosis of PE.

In this multifaceted project we wish to evaluate the effect of an eight week rehabilitation program led and supervised by a trained physiotherapist on exercise capacity in PPS patients. This interventional part of the study will be formed as a randomized controlled trial. Patients will be randomized to either usual care or a physiotherapist-supervised rehabilitation program.

The study also aims to explore potential underlying pathophysiological mechanisms in PPS, using state of the art methods such as cardiac magnetic resonance imaging and transthoracic echocardiography involving novel methods focusing on the right ventricle. The pathophysiological part of the study will be formed as a case control study, where post PE-patients who do not fulfill the criteria for PPS will serve as controls.

Being tested
Rehabilitation
Keywords
Pulmonary embolism, Dyspnea, Post Pulmonary Embolism Syndrome, PPS, Rehabilitation, Cardiac magnetic resonance imaging (CMR)
Medical subject headings
Pulmonary Embolism, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationOther

    Rehabilitation

Study groups in NCT03405480
Study groupRoleWhat they receive
RehabilitationExperimentalPhysiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks.
Receives: Other: Rehabilitation
No rehabilitationNo interventionPatients will receive usual care, including information pamphlets with information on the disease and the general importance of exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ISWT

    Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study

    Measured: ISWT wil be performed at 12 weeks and 36 weeks after baseline

Secondary outcomes (8)

  1. mMRC

    The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale

    Measured: 12 weeks and 36 weeks after inclusion

  2. Sensewear

    The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear)

    Measured: 12 weeks and 36 weeks after baseline

  3. HRQoL by EQ-5d

    The effect of rehabilitation on HRQoL measured by EQ-5D

    Measured: 12 weeks and 36 weeks after baseline

  4. HRQoL by PEmb-QoL

    The effect of rehabilitation on HRQoL measured by PEmb-QoL

    Measured: 12 weeks and 36 weeks after baseline

  5. Long term effect of physical capacity

    The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation

    Measured: 6 months after completing rehabilitation

  6. Test-retest reliability of the ISWT in this patient population

    Test-retest reliability of the ISWT in this patient population

    Measured: At baseline, 12 weeks and 36 weeks

  7. Minimum clinically important difference for ISWT

    Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters.

    Measured: 36 weeks after baseline

  8. Proportion of patients who achieves the established minimum clinically important difference

    Proportion of patients who achieves the established minimum clinically important difference for ISWT for this population

    Measured: 36 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start20 Jan 2018
  3. Primary completion30 Aug 2022
  4. Study completion30 Mar 2024 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03405480
Sponsor's protocol ID
2017/1940 (REK)
Status last verified
Nov 2023
First submitted
11 Jan 2018
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dhayyat A, Stavem K, Jervan O, Hilde JM, Rashid D, Gleditsch J, Ghanima W, Steine K. Stress Echocardiography to Detect Exercise Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Disease. Pulm Med. 2026 Jan 28;2026:4127338. doi: 10.1155/pm/4127338. eCollection 2026.

    PubMed 41623859

  • Jervan O, Dhayyat A, Gleditsch J, Haukeland-Parker S, Tavoly M, Klok FA, Rashid D, Stavem K, Ghanima W, Steine K. Demographic, clinical, and echocardiographic factors associated with residual perfusion defects beyond six months after pulmonary embolism. Thromb Res. 2023 Sep;229:7-14. doi: 10.1016/j.thromres.2023.06.004. Epub 2023 Jun 17.

    PubMed 37356172

  • Jervan O, Haukeland-Parker S, Gleditsch J, Tavoly M, Klok FA, Steine K, Johannessen HH, Spruit MA, Atar D, Holst R, Astrup Dahm AE, Sirnes PA, Stavem K, Ghanima W. The Effects of Exercise Training in Patients With Persistent Dyspnea Following Pulmonary Embolism: A Randomized Controlled Trial. Chest. 2023 Oct;164(4):981-991. doi: 10.1016/j.chest.2023.04.042. Epub 2023 May 5.

    PubMed 37149257

  • 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

  • Haukeland-Parker S, Jervan O, Johannessen HH, Gleditsch J, Stavem K, Steine K, Spruit MA, Holst R, Tavoly M, Klok FA, Ghanima W. Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial. Trials. 2021 Jan 6;22(1):22. doi: 10.1186/s13063-020-04940-9.

    PubMed 33407792

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation in people with Pulmonary Embolism, run by Ostfold Hospital Trust at 1 site in Norway.

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 9 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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 Norway. 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?

Results are not available in the source record.

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?

ISWT (time frame: ISWT wil be performed at 12 weeks and 36 weeks after baseline). 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 NCT03405480, which also lists 5 linked publications.

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 3 Nov 2023.

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