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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01796353
Other study ID # CopenHeart-SF
Secondary ID
Status Completed
Phase N/A
First received February 19, 2013
Last updated May 12, 2017
Start date February 2013
Est. completion date January 2017

Study information

Verified date May 2017
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date January 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
sexual rehabilitation
exercise plus psycho-education
Usual care
usual care

Locations

Country Name City State
Denmark Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9 Copenhagen OE

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Index of Erectile Function (IIEF) 16 week
Secondary Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain 16 week
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