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Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients (CopenHeartSF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01796353
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention
Ischaemic Heart Disease
Cardiac Arrhythmia
Sexual Dysfunction
Other: sexual rehabilitation
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • International Index of Erectile Function (IIEF) [ Time Frame: 16 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain [ Time Frame: 16 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: February 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796353

Contacts
Contact: Selina Berg, PhD selina@rh.dk

Locations
Denmark
Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9 Recruiting
Copenhagen, OE, Denmark, 2100
Contact: Selina Berg, PhD       selina@rh.dk   
Contact: Pernille P Johansen, RN, MCN       pernille.palm.johansen@regionh.dk   
Principal Investigator: Selina Berg, PhD         
Sub-Investigator: Pernille P Johansen, RN, MCN         
Sponsors and Collaborators
Rigshospitalet, Denmark
Bispebjerg Hospital
Investigators
Principal Investigator: Selina Berg, PhD The Heart Centre, Rigshospitalet, Copenhagen, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: Selina Kikkenborg Berg, Researcher, Ph.D, post.doc., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01796353     History of Changes
Other Study ID Numbers: CopenHeart-SF
Study First Received: February 19, 2013
Last Updated: February 21, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
heart disease
sexual dysfunction
exercise test
comprehensive rehabilitation
complex intervention

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Coronary Artery Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014