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OPTICARE-RESST: OPTImizing CArdiac REhabilitation by REfining Sleep and STress

Recruiting
Conditions
cardiac patients
cardiovascular disease
10082206
Registration Number
NL-OMON56876
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

1) Participating in cardiac rehabilitation 2) age above 18 years, 3) proficient
in the Dutch language, 4) 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)

Exclusion Criteria

1) severe psychiatric, cognitive or physical comorbidity that would impede
cardiac rehabilitation participation.
2) 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcomes of the study include both objective and subjective<br /><br>measures of sleep, as well as perceived stress. These outcomes will be assessed<br /><br>before and after the intervention, as well as at a 6-month follow-up.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes encompass quality of life, chronic stress biomarkers,<br /><br>cardiometabolic risk factors, physical fitness, lifestyle components and<br /><br>psychosocial wellbeing. These outcomes will be assessed before and after the<br /><br>intervention, as well as at a 6-month follow-up.</p><br>
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