Clinical trial NCT04257357: Supervised Exercise Following Pulmonary Embolism
Official title: Effect of an 8-week Supervised Exercise Programme on Physical Capacity and Quality of Life in Patients With Pulmonary Embolism. A Randomised Clinical Pilot Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Exercise
Quality of life
Physical capacity
Randomized trial
Pilot study
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: University of Aarhus
name: VIA University College
First posted: 2020-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical pilot trial with 8 weeks of follow-up
Primary purpose: OTHER

Brief summary: In a randomized controlled design the study aims to investigate whether an intervention of 8 weeks supervised bicycle training program in addition to usual care can positively influence the physical capacity and quality of life in patients medically treated for pulmonary embolism.

Detailed description: Background:

The existing knowledge regarding pulmonary embolism is primarily focused on the diagnostic methods and medical treatment of the condition, and furthermore on the short term prognosis in terms of mortality and complications. Few studies have investigated the effect of exercise training on physical capacity and quality of life in patients struck by a pulmonary embolism, although many patients display worries and concerns about their physical and psychological wellbeing after discharge. Furthermore, a number of cross sectional studies and cohort studies have found some patients to have long-term reduced physical capacity and reduced quality of life following pulmonary embolism.

For the time being, no rehabilitation options are available for these patients neither in Denmark, or internationally. As no research exists regarding rehabilitation and exercise for these patients, the study will contribute with important knowledge in terms of what kind of exercise and physical tests we should provide in the future.

Methods and materials:

30 patients medically treated for pulmonary embolism will be recruited from three different hospitals. After inclusion and performance of baseline tests, the patients will be randomly allocated to either the control group, receiving standard care, or the intervention group, receiving an eight-week supervised interval training program in addition to standard care. At the time of inclusion and at the end of the training program (eight-weeks), the patient's physical capacity is measured using Vo2 Max test on an ergometer cycle and by the Incremental shuttle walk test. Furthermore, the patients complete a questionnaire on quality of life (Pulmonary Embolism Quality of Life Questionnaire and Euro-Qol 5 Dimensions), and also, daily physical activity during 7 days will be measured using accelerometry the week prior to baseline test, and the week following the 8-week test.

Statistical analysis:

For the primary outcome, change in physical capacity, parametrical statistics will be used to describe and analyse data (assuming these are normally distributed). For the secondary outcomes on quality oflife, these are ordinal scale data, and therefore will be described and analysed using non-parametrical statistics, while change in average physical activity level as measured with accelerometry and change in walking capacity as measured with the Incremental Shuttle Walk test will be measured using parametrical statistics, assuming a normal distribution of data.

As this is a pilot study the overall aim of the study is the estimate the potential effect of a supervise exercise program and further, to estimate the variance on the Watt-max test and VO2 max for this patient group, in order to calculate the needed sample size for a future full scale randomized controlled trial. In addition the aim of the pilot trial is to assess reach and feasibility of the intervention in this target group.

Expected outcomes and perspective:

The investigators expect that the supervised interval training program will increase the outcome of Vo2 Max, the incremental shuttle walk and PEQoL significantly compared to the control group receiving usual care. The feasibility of the intervention will be assessed, as well as recrution and retention rate of participants. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation for this group of patients and may thereby form the basis of future recommendations in this field.

Eligibility criteria: Inclusion Criteria:

1. Objective verified acute pulmonary embolism (ICD10 I260 and ICD10 I269), recurrent included.
2. Currently treated with anticoagulation medicine.
3. 18-80 years.
4. Speaking and understanding Danish.

Exclusion Criteria:

1. Pulmonary embolism found as a secondary finding scanning for other diseases.
2. In combination with severe comorbidity (e.g. cancer, COPD, heart disease, psychiatric disease like schizophrenia or bipolar disorder), pregnancy or being unable to complete Watt-max test and incremental shuttle walk test.

Primary outcomes:
measure: VO2 max
timeFrame: Change from baseline test to 8 week follow-up (pre- to post-test)
Secondary outcomes:
measure: Pulmonary Embolism Quality of Life
timeFrame: Change in score from baseline to 8 week follow-up
measure: EuroQol 5 Dimensions
timeFrame: Change in score from baseline to 8 week follow-up
measure: Incremental Shuttle-Walk Test
timeFrame: Change in number of meters walked from baseline to 8 week follow-up
measure: Average physical activity
timeFrame: Change in average daily physical activity (7 days) from baseline to 8 week follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Central Jutland Hospital
name: Nanna Rolving, PhD
role: STUDY_CHAIR
References: