Supervised Exercise Following Pulmonary Embolism

NCT04257357 | Withdrawn

• 1 other identifier: 6500012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Embolism

Keywords

Exercise; Quality of life; Physical capacity; Randomized trial; Pilot study

Outcome Measures

Primary Outcomes (1)

• VO2 max

  Change in physical capacity measured as VO2 max during watt-max test (cycle ergometer)

  Change from baseline test to 8 week follow-up (pre- to post-test)

Secondary Outcomes (4)

• Pulmonary Embolism Quality of Life

  Change in score from baseline to 8 week follow-up

• EuroQol 5 Dimensions

  Change in score from baseline to 8 week follow-up

• Incremental Shuttle-Walk Test

  Change in number of meters walked from baseline to 8 week follow-up

• Average physical activity

  Change in average daily physical activity (7 days) from baseline to 8 week follow-up

Study Arms (2)

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

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.

Behavioral: Active control

Interventions

8-weeks supervised exercise program BEHAVIORAL

Please refer to group description

Exercise group

Active control BEHAVIORAL

Please refer to group description

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Objective verified acute pulmonary embolism (ICD10 I260 and ICD10 I269), recurrent included.
• Currently treated with anticoagulation medicine.
• years.
• Speaking and understanding Danish.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator
• VIA University College: collaborator

MeSH Terms

Conditions

Pulmonary Embolism; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Nanna Rolving, PhD

  Central Jutland Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical pilot trial with 8 weeks of follow-up

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: February 20, 2020
• Primary Completion: August 30, 2020
• Study Completion: February 28, 2021
• Last Updated: October 30, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share