Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism
1 other identifier
interventional
209
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2018
CompletedStudy Start
First participant enrolled
January 20, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedNovember 3, 2023
November 1, 2023
4.6 years
January 11, 2018
November 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ISWT
Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study
ISWT wil be performed at 12 weeks and 36 weeks after baseline
Secondary Outcomes (8)
mMRC
12 weeks and 36 weeks after inclusion
Sensewear
12 weeks and 36 weeks after baseline
HRQoL by EQ-5d
12 weeks and 36 weeks after baseline
HRQoL by PEmb-QoL
12 weeks and 36 weeks after baseline
Long term effect of physical capacity
6 months after completing rehabilitation
- +3 more secondary outcomes
Other Outcomes (1)
Myocardial fibrosis evaluated by cardiac MRI
At baseline
Study Arms (2)
Rehabilitation
EXPERIMENTALPhysiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks.
No rehabilitation
NO INTERVENTIONPatients will receive usual care, including information pamphlets with information on the disease and the general importance of exercise.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- Active malignancy
- Life expectancy less than 3 months
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ostfold Hospital Trustlead
- University Hospital, Akershuscollaborator
- Ullevaal University Hospitalcollaborator
Study Sites (1)
The hospital of Østfold, Kalnes
Grålum, 1714, Norway
Related Publications (4)
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.
PMID: 41623859DERIVEDJervan 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.
PMID: 37149257DERIVEDFabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789.
PMID: 34127618DERIVEDHaukeland-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.
PMID: 33407792DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Waleed Ghanima, MD. Assoc.Prof
Hospital of Østfold, Kalnes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2018
First Posted
January 23, 2018
Study Start
January 20, 2018
Primary Completion
August 30, 2022
Study Completion
March 30, 2024
Last Updated
November 3, 2023
Record last verified: 2023-11