Ischaemic Heart DiseaseCopenHeartSFNCT01796353
Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients
A study testing sexual rehabilitation in people with Ischaemic Heart Disease and Cardiac Arrhythmia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ischaemic Heart Disease, Cardiac Arrhythmia, Sexual Dysfunction
- What is being tested?
- sexual rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen, OE, 2100
About this study
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
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.
Read the 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.
- Being tested
- sexual rehabilitation, Usual care
- Keywords
- heart disease, sexual dysfunction, exercise test, comprehensive rehabilitation, complex intervention
- Medical subject headings
- Coronary Artery Disease, Arrhythmias, Cardiac, Sexual Dysfunction, Physiological, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual rehabilitationOther
exercise plus psycho-education
Usual careOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| sexual rehabilitation | Experimental | exercise plus psycho-education Receives: Other: sexual rehabilitation |
| usual care | Active comparator | usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF)
Measured: 16 week
Secondary outcomes (1)
Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Selina Kikkenborg Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Selina Berg, PhD, Principal investigator, The Heart Centre, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796353
- Sponsor's protocol ID
- CopenHeart-SF
- Acronym
- CopenHeartSF
- Status last verified
- May 2017
- First submitted
- 19 Feb 2013
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Palm P, Zwisler AO, Svendsen JH, Thygesen LC, Giraldi A, Jensen KG, Lindschou J, Winkel P, Gluud C, Steinke E, Berg SK. Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial. Heart. 2019 May;105(10):775-782. doi: 10.1136/heartjnl-2018-313778. Epub 2018 Oct 31.
PubMed 30381319Johansen PP, Zwisler AD, Hastrup-Svendsen J, Frederiksen M, Lindschou J, Winkel P, Gluud C, Giraldi A, Steinke E, Jaarsma T, Berg SK. 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. BMJ Open. 2013 Nov 25;3(11):e003967. doi: 10.1136/bmjopen-2013-003967.
PubMed 24282249
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01796353
- Acronym / sponsor ID
- CopenHeartSF / CopenHeart-SF
- Keywords
- heart disease, sexual dysfunction, exercise test, comprehensive rehabilitation, complex intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- Feb 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sexual rehabilitation | Experimental | Other: sexual rehabilitationexercise plus psycho-education |
| usual care | Active comparator | Other: Usual careusual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sexual rehabilitationexercise plus psycho-education | Other | sexual rehabilitation |
| Usual careusual care | Other | usual care |
Primary outcome
International Index of Erectile Function (IIEF)
Time frame: 16 week
1 secondary outcome
Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain
Time frame: 16 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Derived from this study: PubMed 30381319Palm P, Zwisler AO, Svendsen JH, Thygesen LC, Giraldi A, Jensen KG, Lindschou J, Winkel P, Gluud C, Steinke E, Berg SK. Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial. Heart. 2019 May;105(10):775-782. doi: 10.1136/heartjnl-2018-313778. Epub 2018 Oct 31.
- Derived from this study: PubMed 24282249Johansen PP, Zwisler AD, Hastrup-Svendsen J, Frederiksen M, Lindschou J, Winkel P, Gluud C, Giraldi A, Steinke E, Jaarsma T, Berg SK. 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. BMJ Open. 2013 Nov 25;3(11):e003967. doi: 10.1136/bmjopen-2013-003967.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina Berg, PhD principal investigator
The Heart Centre, Rigshospitalet, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexual rehabilitation in people with Ischaemic Heart Disease and Cardiac Arrhythmia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF) (time frame: 16 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796353, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.