Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04257357 |
| Other study ID # |
6500012 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2020 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
February 2020 |
| Source |
Central Jutland Regional Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
