Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT03405480
• Date of registration: 11/01/2018
• Prospective Registration: Yes
• Primary sponsor: Ostfold Hospital Trust
• Public title: Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism
• Scientific title: Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism - a Randomized Controlled Trial - The REHAB Study
• Date of first enrolment: January 20, 2018
• Target sample size: 209
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03405480
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Waleed Ghanima, MD. Assoc.Prof
• Affiliation: Hospital of Østfold, Kalnes

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Embolism

Intervention(s)

Other: Rehabilitation

Primary Outcome(s)

ISWT [Time Frame: ISWT wil be performed at 12 weeks and 36 weeks after baseline]

Secondary Outcome(s)

Long term effect of physical capacity [Time Frame: 6 months after completing rehabilitation]

mMRC [Time Frame: 12 weeks and 36 weeks after inclusion]

HRQoL by EQ-5d [Time Frame: 12 weeks and 36 weeks after baseline]

HRQoL by PEmb-QoL [Time Frame: 12 weeks and 36 weeks after baseline]

Proportion of patients who achieves the established minimum clinically important difference [Time Frame: 36 weeks after baseline]

Minimum clinically important difference for ISWT [Time Frame: 36 weeks after baseline]

Test-retest reliability of the ISWT in this patient population [Time Frame: At baseline, 12 weeks and 36 weeks]

Sensewear [Time Frame: 12 weeks and 36 weeks after baseline]

Secondary ID(s)

2017/1940 (REK)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ullevaal University Hospital

University Hospital, Akershus