CopenHeartSF: Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01796353

Collaborator

Bispebjerg Hospital (Other)

154

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2013

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

International Index of Erectile Function (IIEF) [16 week]

Secondary Outcome Measures

Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain [16 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.