Pulmonary EmbolismNCT04257357
Supervised Exercise Following Pulmonary Embolism
A study testing 8-weeks supervised exercise program in people with Pulmonary Embolism, run by Central Jutland Regional Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- 8-weeks supervised exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objective verified acute pulmonary embolism (ICD10 I260 and ICD10 I269), recurrent included.
- Currently treated with anticoagulation medicine.
- 18-80 years.
- Speaking and understanding Danish.
Who cannot join
- Pulmonary embolism found as a secondary finding scanning for other diseases.
- 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.
About this study
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.
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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- 8-weeks supervised exercise program, Active control
- Keywords
- Exercise, Quality of life, Physical capacity, Randomized trial, Pilot study
- Medical subject headings
- Pulmonary Embolism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-weeks supervised exercise programBehavioural
Please refer to group description
Active controlBehavioural
Please refer to group description
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Eight-week supervised exercise program: Patients in the intervention group receive the same usual care as the patients in the control group. In addition, the patients participate in an eight-week supervised interval training program. Briefly put, the patients are required to participate in at least 16 out of 20 possible training passes over the period of eight weeks. The training consists of a brief warm up followed by 35-50 minutes of interval training on a bicycle. The intensity and duration will increase over time Receives: Behavioral: 8-weeks supervised exercise program |
| Control group | Active comparator | Patients in the control group receive usual care as a minimum. This includes three-five days of hospitalization where the anticoagulant treatment is initiated. The patient and the relatives receive general information about the disease and the course of treatment, the medication and future prevention of embolism. In the year following discharge the patient is booked for a check-up of their anticoagulant treatment with a physician or a nurse as required.
It is considered an active comparator as all patients in the control group perform a watt-max cycle ergometer test with VO2 measurement 3 times, and this in it-self can influence patients' activity level. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
Change in physical capacity measured as VO2 max during watt-max test (cycle ergometer)
Measured: Change from baseline test to 8 week follow-up (pre- to post-test)
Secondary outcomes (4)
Pulmonary Embolism Quality of Life
The Pulmonary Embolism Quality of Life measures self-reported disease-related quality of life. The scale ranges from 0 (best) to 100 (worst).
Measured: Change in score from baseline to 8 week follow-up
EuroQol 5 Dimensions
The EuroQol 5 Dimensions measures self-reported generic health-related quality of life. The 5-digit score is transformed to Time-Trade Off Values (TTO) using the Danish TTO-values, ranging from -0.64 (worst) to 1.000 (perfect health).
Measured: Change in score from baseline to 8 week follow-up
Incremental Shuttle-Walk Test
The Incremental Shuttle Walk test measures the number of meters walked on a 10 meter track. The walking speed is slow at the beginning of the test, and then eventually increases (using auditory beeps), reaching running speed at the end. The number of meters is counted, with 1200 meters being the maximum distance.
Measured: Change in number of meters walked from baseline to 8 week follow-up
Average physical activity
The average daily activity level is measured as an average of 7 consecutive days using an accelerometer (a sensor), worn on the thigh. An average of 7 consecutive days prior to the baseline test and Again 7 consecutive days after the 8 week follow-up test
Measured: Change in average daily physical activity (7 days) from baseline to 8 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start20 Feb 2020 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Why it stopped: Due to Covid-19 pandemia the study was never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical pilot trial with 8 weeks of follow-up
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, VIA University College
- Responsible party
- Sponsor
- Investigators
- Nanna Rolving, PhD, Study chair, Central Jutland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257357
- Sponsor's protocol ID
- 6500012
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the General Data Protection Regulations of EU we donot plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04257357
- Acronym / sponsor ID
- 6500012
- Conditions
- Pulmonary Embolism
- Keywords
- Exercise, Quality of life, Physical capacity, Randomized trial, Pilot study
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to Covid-19 pandemia the study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, VIA University College
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical pilot trial with 8 weeks of follow-up
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: 8-weeks supervised exercise programEight-week supervised exercise program: Patients in the intervention group receive the same usual care as the patients in the control group. In addition, the patients participate in an eight-week supervised interval training program. Briefly put, the patients are required to participate in at least 16 out of 20 possible training passes over the period of eight weeks. The training consists of a brief warm up followed by 35-50 minutes of interval training on a bicycle. The intensity and duration will increase over time |
| Control group | Active comparator | Behavioral: Active controlPatients in the control group receive usual care as a minimum. This includes three-five days of hospitalization where the anticoagulant treatment is initiated. The patient and the relatives receive general information about the disease and the course of treatment, the medication and future prevention of embolism. In the year following discharge the patient is booked for a check-up of their anticoagulant treatment with a physician or a nurse as required. It is considered an active comparator as all patients in the control group perform a watt-max cycle ergometer test with VO2 measurement 3 times, and this in it-self can influence patients' activity level. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Objective verified acute pulmonary embolism (ICD10 I260 and ICD10 I269), recurrent included.
- Currently treated with anticoagulation medicine.
- 18-80 years.
- Speaking and understanding Danish.
Key exclusion criteria (2 listed)
- Pulmonary embolism found as a secondary finding scanning for other diseases.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-weeks supervised exercise programPlease refer to group description | Behavioural | Exercise group |
| Active controlPlease refer to group description | Behavioural | Control group |
Primary outcome
VO2 max
Time frame: Change from baseline test to 8 week follow-up (pre- to post-test)
Change in physical capacity measured as VO2 max during watt-max test (cycle ergometer)
4 secondary outcomes
Pulmonary Embolism Quality of Life
Time frame: Change in score from baseline to 8 week follow-up
EuroQol 5 Dimensions
Time frame: Change in score from baseline to 8 week follow-up
Incremental Shuttle-Walk Test
Time frame: Change in number of meters walked from baseline to 8 week follow-up
Average physical activity
Time frame: Change in average daily physical activity (7 days) from baseline to 8 week follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No. Due to the General Data Protection Regulations of EU we donot plan to make individual participant data available.
Related trials for Pulmonary Embolism
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
RecruitingObservational study
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
Pulmonary Embolism (Diagnosis)
Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
Not yet recruitingPhase 4
Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
Pulmonary Embolism Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanna Rolving, PhD study chair
Central Jutland Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 8-weeks supervised exercise program in people with Pulmonary Embolism, run by Central Jutland Regional Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: Change from baseline test to 8 week follow-up (pre- to post-test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.