PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

Pulmonary Embolism Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615130
• Other study ID #: 1335/2020
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Medical University of Vienna
• Contact: Stephan Nopp, Dr.
• Phone: +43 40400 44170
• Email: stephan.nopp[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Other:
• Rehabilitation
Rehabilitation, exercise training

Locations

Country	Name	City	State
Austria	Therme Wien Med	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Minute Walk Test	change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters	within the 6-week study period
Secondary	peak oxygen consumption	change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry	within the 6-week study period
Secondary	Maximal workload	change of maximal workload in cycle ergometer tests measured in Watt	within the 6-week study period
Secondary	One-repetition maximum for lower extremities	change of one-repetition maximum for lower extremities measured in kg	within the 6-week study period
Secondary	One-repetition maximum for upper extremities	change of one-repetition maximum for upper extremities measured in kg	within the 6-week study period
Secondary	Maximal inspiratory muscle pressure	change in maximum inspiratory muscle pressure measured in mbar	within the 6-week study period
Secondary	Inspiratory muscle endurance	change in inspiratory muscle endurance measured in seconds	within the 6-week study period
Secondary	Level of dyspnea	change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale	within the 6-week study period
Secondary	Health related quality of life	change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L)	within the 6-week study period
Secondary	Disease related quality of life	change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL)	within the 6-week study period
Secondary	Functional limitations	change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form	within the 6-week study period
Secondary	Functional status	change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status)	within the 6-week study period
Secondary	Anxiety and depression	change in anxiety and depression measured with the hospital anxiety and depression scale (HADS)	within the 6-week study period