Status:
RECRUITING
OPTImizing CArdiac REhabilitation by REfining Sleep and STress
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Capri Hartrevalidatie
Maxima Medical Center
Conditions:
Cardiovascular Diseases
Cardiac Rehabilitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this project is to investigate the effectiveness and costs of integrating a behavioural program targeting sleep and stress (the RESST intervention) into cardiac rehabilitation...
Detailed Description
CR focuses on the secondary prevention of cardiovascular disease (CVD) by promoting a healthy lifestyle and is a valuable approach to improve quality of life, mortality and hospital readmissions. Howe...
Eligibility Criteria
Inclusion
- Age at or above 18 years
- Proficient in the Dutch language
- Experiencing sleep and/or stress problems as indicated by a high score on the Pittsburgh Sleep Quality Index (PSQI score \>5) or Perceived Stress Scale-10 (PSS-10 score \>13)
- Signed informed consent
Exclusion
- Severe psychiatric, cognitive or physical comorbidity that would impede CR participation
- Active treatment for sleep disorders, stress, or other forms of (behavioural) therapy at the start of the study or expected to start within the first 6 months of the study, that could interfere with the RESST intervention. Note: Participants with previously diagnosed sleep disorders are eligible if they still experience sleep or stress problems, unless they fall under the above criteria. Participants who received a prior treatment that is still ongoing but has resulted in a stable sleep and stress condition in the 3 months before the cardiovascular event (e.g., Continuous Positive Airway Pressure (CPAP)) are eligible.
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06505109
Start Date
August 28 2024
End Date
January 1 2027
Last Update
June 19 2025
Active Locations (3)
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1
Máxima Medisch Centrum
Eindhoven, North Brabant, Netherlands, 5631BM
2
Capri Hartrevalidatie
Rotterdam, South Holland, Netherlands, 3062MA
3
Capri Hartrevalidatie
The Hague, South Holland, Netherlands, 2597AX