Table 1 Trial registration data
Data category | Information |
|---|---|
Primary registry and trial identification number | ClinicalTrials.gov: NCT02684721 |
Date of registration in primary registry | 20 January 2016 |
Secondary identifying numbers | The Ethics Committee of Central Denmark Region: 1-10-72-243-15 The Danish Data Protection Agency: 1-16-02-494-15 |
Source(s) of monetary or material support | Trygfonden (grant number ID: 115586) Diagnostic Centre, Regional Hospital Silkeborg |
Primary sponsor | Trygfonden |
Secondary sponsor | Diagnostic Centre, Regional Hospital Silkeborg |
Contact for public queries | NR (Nanna.Rolving@midt.rm.dk) |
Contact for scientific queries | NR, LF, BCB |
Public title | The effect of a home-based exercise program after pulmonary embolism |
Scientific title | 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? A multicenter randomized clinical trial |
Country of recruitment | Denmark |
Health condition(s) or problem(s) studied | Home-based exercise after pulmonary embolism |
Interventions | Intervention: 8-week home-based exercise program guided by physiotherapist after discharge from hospital. Control: usual care |
Key inclusion and exclusion criteria | Inclusion criteria: incident primary pulmonary embolism; treatment with anticoagulant drugs; 18–80 years of age; competency in the Danish language. Exclusion criteria: pulmonary embolism secondary to other disease; severe co-morbidity; inability to perform Shuttle Walk test; pregnancy |
Study type | Interventional Allocation: randomized Blinding: assessor and investigator blind |
Date of first enrolment | May 2016 |
Target sample size | 140 |
Recruitment status | Recruiting |
Primary outcome(s) | Incremental Shuttle Walk test Time frame: change from baseline to 6 months after inclusion |
Key secondary outcome(s) | Quality of life (Pulmonary Embolism Quality of Life questionnaire) Sick leave (number of days in a period of 4 weeks) Use of psychotropic drugs (average weekly intake in a period of 2 weeks) |