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Supervised Exercise Following Pulmonary Embolism

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ClinicalTrials.gov Identifier: NCT04257357
Recruitment Status : Withdrawn (Due to Covid-19 pandemia the study was never initiated)
First Posted : February 6, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborators:
Aarhus University Hospital
University of Aarhus
VIA University College
Information provided by (Responsible Party):
Central Jutland Regional Hospital

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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Behavioral: 8-weeks supervised exercise program Behavioral: Active control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical pilot trial with 8 weeks of follow-up
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Due to the intervention (exercise versus usual care) patients and trainers cannot be masked. Outcome assessors will be masked, as it will be different persons performing the 8-week follow-up, who have no knowledge of the group allocation. Furthermore, nurses and doctors providing usual care for the patients at the cardiologic departments are masked for group allocation.
Primary Purpose: Other
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.
Estimated Study Start Date : February 20, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise group
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
Behavioral: 8-weeks supervised exercise program
Please refer to group description

Active Comparator: Control group

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.

Behavioral: Active control
Please refer to group description




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Pulmonary Embolism Quality of Life [ Time Frame: Change in score from baseline to 8 week follow-up ]
    The Pulmonary Embolism Quality of Life measures self-reported disease-related quality of life. The scale ranges from 0 (best) to 100 (worst).

  2. EuroQol 5 Dimensions [ Time Frame: Change in score from baseline to 8 week follow-up ]
    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).

  3. Incremental Shuttle-Walk Test [ Time Frame: Change in number of meters walked from baseline to 8 week follow-up ]
    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.

  4. Average physical activity [ Time Frame: Change in average daily physical activity (7 days) from baseline to 8 week follow-up ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257357


Sponsors and Collaborators
Central Jutland Regional Hospital
Aarhus University Hospital
University of Aarhus
VIA University College
Investigators
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Study Chair: Nanna Rolving, PhD Central Jutland Hospital
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Responsible Party: Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT04257357    
Other Study ID Numbers: 6500012
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the General Data Protection Regulations of EU we donot plan to make individual participant data available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Jutland Regional Hospital:
Exercise
Quality of life
Physical capacity
Randomized trial
Pilot study
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases