Pulmonary EmbolismTEP-RRNCT04150003
Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism
A study testing Pulmonary Rehabilitation program in people with Pulmonary Embolism, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 3 sites in Spain.
Trial summary
Exercise training, as the core component of a Pulmonary Rehabilitation program, may help restore arterial blood flow in the lungs of patients who had suffered Pulmonary Embolism (PE), stimulating and promoting vasodilator effects, repairing the damaged endothelium and recruiting new blood vessels and also inducing a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Pulmonary Rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Nov 2019to 1 Jan 2022
- 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
- Patients 18 years or older at PE diagnosis PE diagnosis confirmed by imaging tests according guidelines Patients under correct anticoagulant treatment Persistent Lung Perfusion Defects at one month after PE diagnosis. Signed Consent Inform
Who cannot join
- Incidental or silent PE Pregnant or puerperal woman Life expectancy less than 6 months Severe comorbidities (NYHA 4 in severe heart failure; COPD, gold D; severe psychiatric illness) Any disability for physical exercise according to their doctors
- -
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Remedios Otero, MD, remeotero@gmail.com
Pilar Cejudo
- Not yet recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Virginia Almadana
Gertrudis Sabadell
- Not yet recruiting
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, 01009
José Luis Lobo, MD, joseluis.loboberistain@osakidetza.eus
About this study
Official title: Multicenter, Randomize Study to Evaluate the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism in the Restoration Lung Perfusion
Exercise training, as the core component of a Pulmonary Rehabilitation program, may help restore arterial blood flow in the lungs of patients who had suffered Pulmonary Embolism (PE), stimulating and promoting vasodilator effects, repairing the damaged endothelium and recruiting new blood vessels and also inducing a net fibrinolytic balance. Besides, exercise training could have a positive effect on quality of life of these patients.
Read the detailed description
An experimental multicenter study is proposed , randomized according to parallel assignation and blinded to third ones to evaluate the effect of a 10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE.
Main objective is to compare the efficacy and safety in terms of quantitative measures from lung scintigraphy, of lung perfusion versus usual care in patients with PE. Additionally the study is aimed to identify bio-markers of response to treatment (mRNAs, MPs and proteomic approach) and to analyze the effects of training on exercise capacity, quality of life parameters and anxiety depression scores.
- Conditions
- Pulmonary Embolism
- Being tested
- Pulmonary Rehabilitation program, Usual care
- Keywords
- Venous Thromboembolic Disease, Pulmonary Embolism, Rehabilitation program, Exercise training
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation programBehavioural
Also called Rehabilitation program
Structured rehabilitation program of directed exercises
Usual careOther
Usual care for patients who had suffered a Pulmonary Embolism
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation program | Experimental | 10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE Receives: Behavioral: Pulmonary Rehabilitation program |
| Usual care | Active comparator | Protocolized usual care for patient suffering PE Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the rate of lung perfusion defects after PE
Lung scintigraphy of lung perfusion
Measured: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Secondary outcomes (5)
Identification of biomarkers of response to treatment
Changes from baseline in the determination of mRNAs
Measured: The day the randomization occurs and the final visit after 12 weeks of the randomization
Identification of another biomarkers of response to treatment
Changes from baseline in the determination of MPs (Microparticle (MP) Microparticles (MPs)
Measured: The day the randomization occurs and the final visit after 12 weeks of the randomization
Change in the percent predicted peak oxygen uptake (VO2 peak) after PE
Peak Oxygen uptake (VO2 peak) is obtained from Cardiopulmonary Exercise Test
Measured: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Change in the EuroQol scale
Visual analog score (0-100, lower score indicate worse outcome)
Measured: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Change in the PEmb-QoL questionnaire by a PEmb-QoL -
PEmb-QoL summary score (0-100, higher score indicate worse outcome)
Measured: "Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Remedios Otero, MD-PhD, Study chair, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150003
- Sponsor's protocol ID
- TEP-RR
- Acronym
- TEP-RR
- Status last verified
- Jan 2021
- First submitted
- 22 Oct 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results to be published in impact factor journals
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomize Study to Evaluate the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism in the Restoration Lung Perfusion
- ClinicalTrials.gov ID
- NCT04150003
- Acronym / sponsor ID
- TEP-RR / TEP-RR
- Conditions
- Pulmonary Embolism
- Keywords
- Venous Thromboembolic Disease, Pulmonary Embolism, Rehabilitation program, Exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 4 Nov 2019 (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.
Exercise training, as the core component of a Pulmonary Rehabilitation program, may help restore arterial blood flow in the lungs of patients who had suffered Pulmonary Embolism (PE), stimulating and promoting vasodilator effects, repairing the damaged endothelium and recruiting new blood vessels and also inducing a net fibrinolytic balance. Besides, exercise training could have a positive effect on quality of life of these patients.
Detailed description
An experimental multicenter study is proposed , randomized according to parallel assignation and blinded to third ones to evaluate the effect of a 10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE.
Main objective is to compare the efficacy and safety in terms of quantitative measures from lung scintigraphy, of lung perfusion versus usual care in patients with PE. Additionally the study is aimed to identify bio-markers of response to treatment (mRNAs, MPs and proteomic approach) and to analyze the effects of training on exercise capacity, quality of life parameters and anxiety depression scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation program | Experimental | Behavioral: Pulmonary Rehabilitation program10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE |
| Usual care | Active comparator | Other: Usual careProtocolized usual care for patient suffering PE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years or older at PE diagnosis PE diagnosis confirmed by imaging tests according guidelines Patients under correct anticoagulant treatment Persistent Lung Perfusion Defects at one month after PE diagnosis. Signed Consent Inform
Key exclusion criteria (2 listed)
- Incidental or silent PE Pregnant or puerperal woman Life expectancy less than 6 months Severe comorbidities (NYHA 4 in severe heart failure; COPD, gold D; severe psychiatric illness) Any disability for physical exercise according to their doctors
- -
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 programAlso: Rehabilitation programStructured rehabilitation program of directed exercises | Behavioural | Pulmonary Rehabilitation program |
| Usual careUsual care for patients who had suffered a Pulmonary Embolism | Other | Usual care |
Primary outcome
Change in the rate of lung perfusion defects after PE
Time frame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Lung scintigraphy of lung perfusion
5 secondary outcomes
Identification of biomarkers of response to treatment
Time frame: The day the randomization occurs and the final visit after 12 weeks of the randomization
Identification of another biomarkers of response to treatment
Time frame: The day the randomization occurs and the final visit after 12 weeks of the randomization
Change in the percent predicted peak oxygen uptake (VO2 peak) after PE
Time frame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Change in the EuroQol scale
Time frame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Change in the PEmb-QoL questionnaire by a PEmb-QoL -
Time frame: "Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: Yes. Results to be published in impact factor journals
Related trials for Pulmonary Embolism
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Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
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Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
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Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
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Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
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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.
Remedios Otero, MD-PhD study chair
Hospitales Universitarios Virgen del Rocío
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation program in people with Pulmonary Embolism, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 3 sites in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Contact Remedios Otero, Md-PHd (0034955012144, remeotero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the rate of lung perfusion defects after PE (time frame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization). 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 14 Jan 2021.