An interventional study of sexual rehabilitation and Usual care in Ischaemic Heart Disease, Cardiac Arrhythmia and Sexual Dysfunction, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Copenhagen University Hospital, Rigshospitalet · Not applicable, Interventional, and Health services research
The objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component.
The primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual function.
Sexual function is an important aspect of quality of life. There is a link between heart disease and sexual dysfunction. Heart disease lowers the activity or the ability to perform the sexual activity. Sexual problems have a negative impact on quality of life and well-being, and sexual dysfunction is associated with anxiety and depression. The causes of sexual dysfunction are physical changes (the disease), mental changes and adverse reactions from medication. Despite the fact, that several international guidelines recommend that health professionals address sexual function in patients with heart disease, this is rarely done in practice. In Denmark there is no consensus or practice on how or where patients with heart disease and sexual dysfunction should be treated. Some patients are treated with phosphodiesterase type 5 inhibitors and a few referred to sexological clinics. Non-pharmacological rehabilitation interventions such as physical exercise, pelvic floor exercise, and sexual therapy have shown potential beneficial effect on sexual function. However, the effects have not been tested sufficiently, have not been tested in combination, and have never been tested in a Danish population.
Objective: The objective of this trial is to investigate the effect of a comprehensive sexual rehabilitation intervention program, consisting of a psycho-educative component and an exercise-training component plus treatment as usual versus treatment as usual in male patients with impaired sexual function and implantable cardioverter defibrillator or ischemic heart disease.
Design: CopenHeartSF is an investigator-initiated randomised clinical trial with blinded outcome assessment, including two university hospitals, with 1:1 central randomisation to sexual rehabilitation plus usual care versus usual care alone.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 154 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
exercise plus psycho-education
Other: sexual rehabilitation
usual care
Other: Usual care
exercise plus psycho-education
usual care
International Index of Erectile Function (IIEF)
Time frame: 16 week
Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain
Time frame: 16 week
The record gives a start of Feb 2013, a primary completion of Nov 2016 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital, Rigshospitalet