Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01558765
Other study ID # RHCopenHeartVR
Secondary ID
Status Completed
Phase Phase 2
First received March 16, 2012
Last updated November 12, 2015
Start date March 2012
Est. completion date May 2015

Study information

Verified date November 2015
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.

The hypothesis is that integrated rehabilitation can improve physical capacity measured by V02 peak, self-rated mental health and life quality by validated questionnaires such as SF-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.


Description:

Worldwide, the incidence of heart valve disease is increasing. Improved surgical techniques, rising age and possibility for re-operation leads to a rising number of patients having heart valve surgery. The gap between hospital discharge and returning to normal life is obvious. Integrated rehabilitation could probably reduce hospital readmissions, increase physical capacity and increase self-rated mental health and quality of life. Therefore the aim of this study is to explore if patients after heart valve surgery will benefit from an integrated rehabilitation programme consisting of physical exercise and psycho-educational intervention.

A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients after heart valve surgery. The trial is a parallel arm design.

A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences.

Along with the above stated hypothesis, it will be observed whether integrated rehabilitation can reduce anxiety, depression, health care utilisation, mortality and work cessation.

210 patients will be included.

Validated questionnaires (e.g. SF-36), cardiopulmonary exercise testing, 6 minute walking test, echocardiography, cardiac-specific biomarkers and qualitative interviews will be used to evaluate the effect and meaning of the programme.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Admitted to hospital for elective heart valve surgery at Rigshospitalet, Denmark

- 18 years or older

- Speak and understand Danish

- Providing written informed consent

Exclusion Criteria:

- Known ischemic heart disease prior to heart valve surgery

- Is included in an other clinical trial investigating the effects of physical training and psycho-educational intervention

- Unable to understand and cooperate to study instructions

- Pregnant and/or breast feeding

- Performing exercise training at high level and several times a week

- No written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Integrated rehabilitation
Integrated rehabilitation consisting of exercise training (3 times per week (1 hour) for 12 weeks) and psycho-educational care (5 consultations over 6 months by special trained nurses).

Locations

Country Name City State
Denmark Rigshospitalet / Copenhagen University Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in physical capacity Measured by Vo2peak by ergospirometry testing 1,4,12 months Yes
Secondary Change in self-rated mental health and quality of life Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire. 0, 1, 4, 6, 12 and 24 months No
See also
  Status Clinical Trial Phase
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT02527629 - Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A
Completed NCT01426776 - Effect of Heart Valve Replacement on Cheyne-Stokes Respiration N/A
Completed NCT00581399 - A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery Phase 2
Withdrawn NCT00187304 - ACTION - Anticoagulation Treatment Influence on Post-operative Patients Phase 4
Terminated NCT00700947 - Using Beta Blockers to Treat Mitral Regurgitation Phase 1
Recruiting NCT02650388 - Frailty and Cognitive Function Assessment of TAVI Patients Phase 4
Recruiting NCT02574650 - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. N/A
Completed NCT01996657 - D-dimer and Oral Anticoagulation Therapy in Patients With Mechanical Valve Replacement N/A
Terminated NCT00598936 - A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients Phase 1
Terminated NCT01812174 - On-X Heart Valve - 17mm Aortic and 23mm Mitral N/A
Recruiting NCT03225612 - Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) N/A
Completed NCT01384643 - Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery Phase 4
Active, not recruiting NCT00291525 - Randomized On-X Anticoagulation Trial N/A
Completed NCT02867930 - Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography Phase 4
Recruiting NCT02478008 - A Clinical Study of the CardiAQ™ TMVI System (Transapical DS) N/A
Completed NCT02790008 - Magnetic Resonance Imaging and Fibrosis
Completed NCT02587039 - An Intervention to Reduce Delirium After Cardiac Surgery N/A
Recruiting NCT01855737 - The Study of Warfarin Maintenance Dose in Chinese Patients Phase 4