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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. Identifier: NCT01796353
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : May 15, 2017
Bispebjerg Hospital
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark

Brief Summary:

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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: sexual rehabilitation
exercise plus psycho-education
Other: sexual rehabilitation
exercise plus psycho-education

Active Comparator: usual care
usual care
Other: Usual care
usual care

Primary Outcome Measures :
  1. International Index of Erectile Function (IIEF) [ Time Frame: 16 week ]

Secondary Outcome Measures :
  1. Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain [ Time Frame: 16 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male patients above 18 years with sexual dysfunction associated with implantable cardioverter defibrillator or with ischemic heart disease verified by coronary angiography, which have a partner, speaks and understands Danish and provides a written informed consent

Exclusion Criteria:

  • Patients at intermediate or high risk according to their cardiovascular status according to guidelines, with diseases in the urinary tract, who exercise intense more than 3 hours a week, patients with neurological or orthopedic deficits which prevent training, patients with cognitive deficits which prevents interviews, and patients who are included in ongoing research prohibiting additional research participation are excluded.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01796353

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Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen, OE, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Bispebjerg Hospital
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Principal Investigator: Selina Berg, PhD The Heart Centre, Rigshospitalet, Copenhagen, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Selina Kikkenborg Berg, Researcher, Ph.D, post.doc., Rigshospitalet, Denmark Identifier: NCT01796353    
Other Study ID Numbers: CopenHeart-SF
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Keywords provided by Selina Kikkenborg Berg, Rigshospitalet, Denmark:
heart disease
sexual dysfunction
exercise test
comprehensive rehabilitation
complex intervention
Additional relevant MeSH terms:
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Heart Diseases
Arrhythmias, Cardiac
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases