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PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome (PURE-PE)

Primary Purpose

Pulmonary Embolism

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Rehabilitation

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Rehabilitation, Exercise Training, Pulmonary Embolism

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Therme Wien MedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Patients will undergo 6 weeks of outpatient rehabilitation.

Patients will receive no intervention throughout the 6 weeks period.

Outcomes

Primary Outcome Measures

6-Minute Walk Test

change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters

Secondary Outcome Measures

peak oxygen consumption

change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry

Maximal workload

change of maximal workload in cycle ergometer tests measured in Watt

One-repetition maximum for lower extremities

change of one-repetition maximum for lower extremities measured in kg

One-repetition maximum for upper extremities

change of one-repetition maximum for upper extremities measured in kg

Maximal inspiratory muscle pressure

change in maximum inspiratory muscle pressure measured in mbar

Inspiratory muscle endurance

change in inspiratory muscle endurance measured in seconds

Level of dyspnea

change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale

Health related quality of life

change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L)

Disease related quality of life

change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL)

Functional limitations

change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form

Functional status

change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status)

Anxiety and depression

change in anxiety and depression measured with the hospital anxiety and depression scale (HADS)

Full Information

NCT ID

NCT04615130

First Posted

October 22, 2020

Last Updated

May 6, 2022

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT04615130

Brief Title

PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

Acronym

PURE-PE

Official Title

Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

Keywords

Pulmonary Rehabilitation, Exercise Training, Pulmonary Embolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

As the control group will undergo rehabilitation after the study period as well, it is possible to blind patients and outcome assessors to the treatment group.

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Patients will undergo 6 weeks of outpatient rehabilitation.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Patients will receive no intervention throughout the 6 weeks period.

Intervention Type

Other

Intervention Name(s)

Rehabilitation

Intervention Description

Rehabilitation, exercise training

Primary Outcome Measure Information:

Title

6-Minute Walk Test

Description

change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters

Time Frame

within the 6-week study period

Secondary Outcome Measure Information:

Title

peak oxygen consumption

Description

change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry

Time Frame

within the 6-week study period

Title

Maximal workload

Description

change of maximal workload in cycle ergometer tests measured in Watt

Time Frame

within the 6-week study period

Title

One-repetition maximum for lower extremities

Description

change of one-repetition maximum for lower extremities measured in kg

Time Frame

within the 6-week study period

Title

One-repetition maximum for upper extremities

Description

change of one-repetition maximum for upper extremities measured in kg

Time Frame

within the 6-week study period

Title

Maximal inspiratory muscle pressure

Description

change in maximum inspiratory muscle pressure measured in mbar

Time Frame

within the 6-week study period

Title

Inspiratory muscle endurance

Description

change in inspiratory muscle endurance measured in seconds

Time Frame

within the 6-week study period

Title

Level of dyspnea

Description

change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale

Time Frame

within the 6-week study period

Title

Health related quality of life

Description

change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L)

Time Frame

within the 6-week study period

Title

Disease related quality of life

Description

change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL)

Time Frame

within the 6-week study period

Title

Functional limitations

Description

change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form

Time Frame

within the 6-week study period

Title

Functional status

Description

change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status)

Time Frame

within the 6-week study period

Title

Anxiety and depression

Description

change in anxiety and depression measured with the hospital anxiety and depression scale (HADS)

Time Frame

within the 6-week study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephan Nopp, Dr.

Phone

+43 40400 44170

stephan.nopp@meduniwien.ac.at

Facility Information:

Facility Name

Therme Wien Med

City

Vienna

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan Nopp, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34127618

Citation

Fabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789.

Results Reference

derived

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PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

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