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

Abstract

IntroductionSexuality is an important part of people’s physical and mental health. Patients with heart disease often suffer from sexual dysfunction. Sexual dysfunction has a negative impact on quality of life and well-being in persons with heart disease, and sexual dysfunction is associated with anxiety and depression. Treatment and care possibilities seem to be lacking. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation possess the potential of reducing sexual dysfunction in patients with heart disease. The CopenHeartSF trial will investigate the effect of a comprehensive sexual rehabilitation programme versus usual care.Methods and analysisCopenHeartSF is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 central randomisation to sexual rehabilitation plus usual care versus usual care alone. Based on sample size calculations, 154 male patients with impaired sexual function due to implantable cardioverter defibrillator or ischaemic heart disease will be included from two university hospitals in Denmark. All patients receive usual care and patients allocated to the experimental intervention group follow a 12-week sexual rehabilitation programme consisting of an individualised exercise programme and psychoeducative consultation with a specially trained nurse. The primary outcome is sexual function measured by the International Index of Erectile Function. The secondary outcome measure is psychosocial adjustment to illness by the Psychosocial Adjustment to Illness Scale, sexual domain. A number of explorative analyses will also be conducted.Ethics and disseminationCopenHeartSF is approved by the regional ethics committee (no H-4-2012-168) and the Danish Data Protection Agency (no 2007-58-0015) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form.RegistrationClinicaltrials.gov identifier: NCT01796353.

A place of understanding: Patients' lived experiences of participating in a sexual rehabilitation programme after heart disease

“…Patients were all participants from a RCT evaluating the effect of a sexual rehabilitation programme consisting of 12‐week physical exercise training including daily pelvic floor exercise and psycho‐educational consultations up to four sessions. A trial protocol and results from the RCT was published .…”

“…Therefore, the CopenHeart SF randomised controlled trial (RCT) was designed with the purpose of testing whether a nonpharmacological sexual rehabilitation intervention consisting of exercise training and psycho‐education would improve male cardiovascular patient's sexual function . The primary outcome was the total sum score on the International Index of Erectile Function (IIEF), and a questionnaire evaluating sexual function and primary results from the RCT showed a statistically significant difference in favour of the sexual rehabilitation group .…”

Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial

“…The CopenHeart SF trial (SF: sexual function)12 is a randomised clinical trial comparing sexual rehabilitation versus usual care. The trial complies with the Declaration of Helsinki and was registered at ClinicalTrials.gov (NCT01796353 (results)).…”

“…Consultations were carried out by a specially trained nurse and were conducted as individualised sessions. An inspirational guide consisting of components such as sexological and medical history, psychosocial and psychological concerns was developed, and served as a basis for the consultations 12. The topics discussed were: causes of sexual dysfunction, sexual concerns, level of sexual activity, types of activities, relationship, sexual problems, comorbidity and medication.…”

Sexual counseling and cardiovascular disease: practical approaches

“…One promising study in progress includes a 12 weeks sexual rehabilitation program for men with an ICD or ischemic heart disease. 32 This is a follow-up to a preliminary study of 196 ICD patients that elicited patient concerns related sexual function and changes in sexual behavior, but yielded no differences in the intervention and control groups. 33 For the later study, more intensive exercise and training plan, as well as a psycho-educational intervention are planned components of the intervention.…”