NCT01796353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

February 19, 2013

Last Update Submit

May 12, 2017

Conditions

Ischaemic Heart DiseaseCardiac ArrhythmiaSexual Dysfunction

Keywords

heart diseasesexual dysfunctionexercise testcomprehensive rehabilitationcomplex intervention

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Function (IIEF)

    16 week

Secondary Outcomes (1)

  • Psychosocial adjustment to illness scale (PAIS-SR)sexual relationship domain

    16 week

Study Arms (2)

sexual rehabilitation

EXPERIMENTAL

exercise plus psycho-education

Other: sexual rehabilitation

usual care

ACTIVE COMPARATOR

usual care

Other: Usual care

Interventions

sexual rehabilitationOTHER

exercise plus psycho-education

sexual rehabilitation
Usual careOTHER

usual care

usual care

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9

Copenhagen, OE, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 30381319DERIVED

  • Johansen 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.

    PMID: 24282249DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseArrhythmias, CardiacSexual Dysfunction, PhysiologicalHeart Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Officials

  • Selina Berg, PhD

    The Heart Centre, Rigshospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Ph.D, post.doc.

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 21, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

DK(1)