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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sexual rehabilitation | Experimental | exercise plus psycho-education |
|
| usual care | Active Comparator | usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sexual rehabilitation | Other | exercise plus psycho-education |
| |
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile Function (IIEF) | 16 week |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain | 16 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selina Berg, PhD | The Heart Centre, Rigshospitalet, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9 | Copenhagen | OE | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30381319 | Derived | Palm P, Zwisler AO, Svendsen JH, Thygesen LC, Giraldi A, Jensen KG, Lindschou J, Winkel P, Gluud C, Steinke E, Berg SK. Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial. Heart. 2019 May;105(10):775-782. doi: 10.1136/heartjnl-2018-313778. Epub 2018 Oct 31. | |
| 24282249 | Derived |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001145 | Arrhythmias, Cardiac |
| D012735 | Sexual Dysfunction, Physiological |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| Usual care |
| Other |
usual care |
|
| Johansen PP, Zwisler AD, Hastrup-Svendsen J, Frederiksen M, Lindschou J, Winkel P, Gluud C, Giraldi A, Steinke E, Jaarsma T, Berg SK. The CopenHeartSF trial--comprehensive sexual rehabilitation programme for male patients with implantable cardioverter defibrillator or ischaemic heart disease and impaired sexual function: protocol of a randomised clinical trial. BMJ Open. 2013 Nov 25;3(11):e003967. doi: 10.1136/bmjopen-2013-003967. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |