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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01796353
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013

February 19, 2013
February 21, 2013
February 2013
June 2014   (final data collection date for primary outcome measure)
International Index of Erectile Function (IIEF) [ Time Frame: 16 week ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Psychosocial adjustment to illness scale (PAIS-SR)sexual relationsship domain [ Time Frame: 16 week ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
Not Provided
June 2014   (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.
Male
18 Years and older
No
Contact: Selina Berg, PhD selina@rh.dk
Denmark
 
NCT01796353
CopenHeart-SF
No
Selina Kikkenborg Berg, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Bispebjerg Hospital
Principal Investigator: Selina Berg, PhD The Heart Centre, Rigshospitalet, Copenhagen, Denmark
Rigshospitalet, Denmark
February 2013

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