Does a Home-based Exercise Programme Affect Physical Capacity and Quality of Life in Patients With Pulmonary Embolism?

NCT02684721 | Completed

• 1 other identifier: 6300001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

In a randomised design the study aims to investigate whether an intervention of 8 weeks home-based exercise in addition to usual care can positively influence the physical capacity, quality of life, sick leave and use of psychoactive drugs in patients medically treated for pulmonary embolism.

Conditions

Pulmonary Embolism

Keywords

rehabilitation; physical capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Incremental Shuttle Walk test from baseline to 6 months after baseline

  Validated outcome measure for assessing a person's maximum walking capacity

  Baseline, 2 months and 6 months after baseline

Secondary Outcomes (4)

• Change in Pulmonary Embolism Quality of Life from baseline to 6 months

  Baseline, 2 months and 6 months after baseline

• Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months

  Baseline, 2 months and 6 months after baseline

• Sick leave in the past 4 weeks measured at 2 and 6 month follow-up

  Baseline, 2 months and 6 months after baseline

• Average weekly use of psychoactive drugs in the past 4 weeks measured at 2 and 6 month follow-up

  Baseline, 2 months and 6 months after baseline

Study Arms (2)

Control group

NO INTERVENTION

Patients in the control group receive usual care as a minimum. This includes 3-5 days of hospitalisation 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.

Exercise group

EXPERIMENTAL

8-week home-base exercise programme: Patients in the intervention group receive the same usual care as patients in the control group. In addition the patients participate in an 8 week home-based exercise programme, including follow-up telephone calls with the physiotherapist after 1 week, 2 weeks and 4 weeks. Briefly put, the patients are required to exercise for a minimum of 3 times per week for 30-60 minutes, and with 3-4 intervals of approximately 1 minute at a high intensity level. Total exercise time and intervals increase during the 8 week programme. The patients can choose whatever type of exercise they prefer, and they are generally encouraged to choose something they already do, or something that they have previously had positive experiences doing.

Other: 8-week home-based exercise programme

Interventions

8-week home-based exercise programme OTHER

8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.

Exercise group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Objectively verified acute pulmonary embolism
• Treatment with anticoagulant drugs
• years of age
• Competency in the Danish language

You may not qualify if:

• Pulmonary embolism as a secondary finding in relation to scan performed due to another disease.
• Severe co-morbidity (malignant, inflammatory or psychiatric)
• Unable to perform the Incremental Shuttle Walk test for other reasons (e.g. amputation or intermittent claudication).

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• Aalborg University Hospital: collaborator
• Horsens Hospital: collaborator
• Regional Hospital West Jutland: collaborator

Study Sites (3)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Regional hospital Herning

Herning, 7400, Denmark

Location

Diagnostic Centre, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

Related Publications (3)

• Rolving N, Brocki BC, Mikkelsen HR, Ravn P, Bloch-Nielsen JR, Frost L. Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial. Trials. 2017 May 30;18(1):245. doi: 10.1186/s13063-017-1939-y.

  PMID: 28558825 BACKGROUND

• Rolving N, Brocki BC, Andreasen J. Coping with everyday life and physical activity in the aftermath of an acute pulmonary embolism: A qualitative study exploring patients' perceptions and coping strategies. Thromb Res. 2019 Oct;182:185-191. doi: 10.1016/j.thromres.2019.06.007. Epub 2019 Jun 19.

  PMID: 31262439 BACKGROUND

• Rolving N, Brocki BC, Bloch-Nielsen JR, Larsen TB, Jensen FL, Mikkelsen HR, Ravn P, Frost L. Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200064. doi: 10.1001/jamanetworkopen.2020.0064.

  PMID: 32108888 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Nanna Rolving, PhD

  Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 18, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 19, 2019

Record last verified: 2016-11

Locations

DK (3)