Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients (CopenHeartSF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01796353|
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : May 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Ischaemic Heart Disease Cardiac Arrhythmia Sexual Dysfunction||Other: sexual rehabilitation Other: Usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Clinical Trial of a Comprehensive Sexual Rehabilitation Programme Versus Usual Care in Male Patients With Impaired Sexual Function and Ischemic Heart Disease or Implantable Cardioverter Defibrillator|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||January 2017|
Experimental: sexual rehabilitation
exercise plus psycho-education
Other: sexual rehabilitation
exercise plus psycho-education
Active Comparator: usual care
Other: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796353
|Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9|
|Copenhagen, OE, Denmark, 2100|
|Principal Investigator:||Selina Berg, PhD||The Heart Centre, Rigshospitalet, Copenhagen, Denmark|