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

Pernille Palm Johansen; Ann-Dorthe Zwisler; Jesper Hastrup Svendsen; Marianne Frederiksen; Jane Lindschou; Per Winkel; Christian Gluud; Annamaria Giraldi; Elaine Steinke; Tiny Jaarsma; Selina Kikkenborg Berg

doi:10.1136/bmjopen-2013-003967

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

Pernille Palm Johansen, Ann-Dorthe Zwisler, Jesper Hastrup Svendsen, Marianne Frederiksen, Jane Lindschou, Per Winkel, Christian Gluud, Annamaria Giraldi, Elaine Steinke, Tiny Jaarsma, Selina Kikkenborg Berg

8 Citations (Scopus)

Abstract

Introduction: Sexuality 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 analysis: CopenHeartSF 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 dissemination: CopenHeartSF 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. Registration: Clinicaltrials.gov identifier: NCT01796353.

Original language	English
Article number	e003967
Journal	B M J Open
Volume	3
Number of pages	11
ISSN	2044-6055
DOIs	https://doi.org/10.1136/bmjopen-2013-003967
Publication status	Published - 2013

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Johansen, P. P., Zwisler, A-D., Svendsen, J. H., Frederiksen, M., Lindschou, J., Winkel, P., Gluud, C., Giraldi, A., Steinke, E., Jaarsma, T., & Berg, S. K. (2013). 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. B M J Open, 3, [e003967]. https://doi.org/10.1136/bmjopen-2013-003967

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. / Johansen, Pernille Palm; Zwisler, Ann-Dorthe; Svendsen, Jesper Hastrup et al.

In: B M J Open, Vol. 3, e003967, 2013.

Research output: Contribution to journal › Journal article › Research › peer-review

Johansen, PP, Zwisler, A-D, Svendsen, JH, Frederiksen, M, Lindschou, J, Winkel, P, Gluud, C, Giraldi, A, Steinke, E, Jaarsma, T & Berg, SK 2013, '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', B M J Open, vol. 3, e003967. https://doi.org/10.1136/bmjopen-2013-003967

Johansen PP, Zwisler A-D, Svendsen JH, Frederiksen M, Lindschou J, Winkel P et al. 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. B M J Open. 2013;3:e003967. doi: 10.1136/bmjopen-2013-003967

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title = "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 = "Introduction: Sexuality 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 analysis: CopenHeartSF 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 dissemination: CopenHeartSF 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. Registration: Clinicaltrials.gov identifier: NCT01796353.",

author = "Johansen, {Pernille Palm} and Ann-Dorthe Zwisler and Svendsen, {Jesper Hastrup} and Marianne Frederiksen and Jane Lindschou and Per Winkel and Christian Gluud and Annamaria Giraldi and Elaine Steinke and Tiny Jaarsma and Berg, {Selina Kikkenborg}",

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doi = "10.1136/bmjopen-2013-003967",

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T1 - The CopenHeartSF trial—comprehensive sexual rehabilitation programme for male patients with implantable cardioverter defibrillator or ischaemic heart disease and impaired sexual function

T2 - protocol of a randomised clinical trial

AU - Johansen, Pernille Palm

AU - Zwisler, Ann-Dorthe

AU - Svendsen, Jesper Hastrup

AU - Frederiksen, Marianne

AU - Lindschou, Jane

AU - Winkel, Per

AU - Gluud, Christian

AU - Giraldi, Annamaria

AU - Steinke, Elaine

AU - Jaarsma, Tiny

AU - Berg, Selina Kikkenborg

PY - 2013

Y1 - 2013

N2 - Introduction: Sexuality 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 analysis: CopenHeartSF 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 dissemination: CopenHeartSF 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. Registration: Clinicaltrials.gov identifier: NCT01796353.

AB - Introduction: Sexuality 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 analysis: CopenHeartSF 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 dissemination: CopenHeartSF 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. Registration: Clinicaltrials.gov identifier: NCT01796353.

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DO - 10.1136/bmjopen-2013-003967

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