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Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients (CopenHeartSF)

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ClinicalTrials.gov Identifier: NCT01796353
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):

February 19, 2013
February 21, 2013
May 15, 2017
February 2013
November 2016   (Final data collection date for primary outcome measure)
International Index of Erectile Function (IIEF) [ Time Frame: 16 week ]
Same as current
Complete list of historical versions of study NCT01796353 on ClinicalTrials.gov Archive Site
Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain [ Time Frame: 16 week ]
Psychosocial adjustment to illness scale (PAIS-SR)sexual relationsship domain [ Time Frame: 16 week ]
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Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients
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

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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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Ischaemic Heart Disease
  • Cardiac Arrhythmia
  • Sexual Dysfunction
  • Other: sexual rehabilitation
    exercise plus psycho-education
  • Other: Usual care
    usual care
  • Experimental: sexual rehabilitation
    exercise plus psycho-education
    Intervention: Other: sexual rehabilitation
  • Active Comparator: usual care
    usual care
    Intervention: 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. Erratum in: BMJ Open. 2017 Jan 23;7(1):e003967corr1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2017
November 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Selina Kikkenborg Berg, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Bispebjerg Hospital
Principal Investigator: Selina Berg, PhD The Heart Centre, Rigshospitalet, Copenhagen, Denmark
Rigshospitalet, Denmark
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP