OPTImizing CArdiac REhabilitation by REfining Sleep and STress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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 (CR). In addition, the investigators will also study whether parameters regarding diversity (e.g., sex, ethnicity, socioeconomic position) are associated with intervention effectiveness. Furthermore, the investigators aim to explore the (bidirectional) relation between sleep and stress on the one hand, and other lifestyle components and health outcomes on the other hand.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participate in CR at one of the study centres for any cardiac diagnosis or reason as stated in the Dutch guidelines
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
RESST
BehavioralSubjects randomized to the RESST intervention will receive on top of standard rehabilitation a behavioural group intervention focussing on improving sleep and stress. This intervention will consist of 5 group sessions of 120 minutes each in the local rehabilitation centre. Sessions should be completed within a maximum of 4 months since the start of CR.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Objectively assessed sleep duration
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Time frame
At baseline, after 3 months, and after 6 months.2
Objectively assessed sleep-onset latency
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Time frame
At baseline, after 3 months, and after 6 months.3
Objectively assessed wake after sleep onset
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Time frame
At baseline, after 3 months, and after 6 months.4
Objectively assessed sleep efficiency
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Time frame
At baseline, after 3 months, and after 6 months.Secondary outcomes
1
Cortisol level
This will be measured by taking a hair sample. The amount of cortisol in the hair will be determined in a lab.
Time frame
At baseline, after 3 months, and after 6 months.2
Cortisone level
This will be measured by taking a hair sample. The amount of cortisone in the hair will be determined in a lab.
Time frame
At baseline, after 3 months, and after 6 months.3
Weight
Weight will be measured with a digital scale in kilograms.
Time frame
At baseline, after 3 months, and after 6 months.4
Height
Height will be measured with a stadiometer in centimeters.
Time frame
At baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Capri Hartrevalidatie
Collaborator
Maxima Medical Center
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov