OPTImizing CArdiac REhabilitation by REfining Sleep and STress (OPTICARE-RESST)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Cardiac Rehabilitation
• Intervention / Treatment: Behavioral: RESST

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. However, optimization of CR is necessary. Current CR programs pay insufficient attention to sleep and stress problems, despite more than 50% of CVD patients experiencing sleep problems and high stress levels. Both sleep and stress are associated with adverse cardiovascular health and a decreased quality of life. The hypothesis for this study is that adding a behavioural intervention will improve sleep and perceived stress (primary outcomes), along with positive outcomes on biomarkers of chronic stress, QoL, cardiometabolic risk factors, physical fitness, lifestyle components, and psychosocial well-being.

The project involves a multicenter randomized controlled trial. The intervention group (100 patients) will receive standard CR along with the RESST intervention, consisting of 5-6 on-site group sessions integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy and focused on improving sleep and stress. The control group (100 patients) will receive standard multidisciplinary CR only.

The primary outcomes of the study include both objective and subjective measures of sleep, as well as perceived stress. Secondary outcomes encompass quality of life, chronic stress biomarkers, cardiometabolic risk factors, physical fitness, lifestyle components and psychosocial wellbeing. These outcomes will be assessed before and after the intervention, as well as at a 6-month follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nienke ter Hoeve, PhD; Phone Number: +31107033190; Email: n.terhoeve@erasmusmc.nl

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5631BM
      • Recruiting
      • Maxima Medisch Centrum
      • Contact: Esmée Ooms, MSc; Phone Number: +31622366387; Email: e.ooms@erasmusmc.nl
      • Contact: Inge van Loon, MSc; Phone Number: +31622366387; Email: i.g.vanloon@erasmusmc.nl
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3062MA
      • Recruiting
      • Capri Hartrevalidatie
      • Contact: Esmée Ooms, MSc; Phone Number: +31622366387; Email: e.ooms@erasmusmc.nl
      • Contact: Inge van Loon, MSc; Phone Number: +31622366387; Email: i.g.vanloon@erasmusmc.nl
    • The Hague, South Holland, Netherlands, 2597AX
      • Recruiting
      • Capri Hartrevalidatie
      • Contact: Esmée Ooms, MSc; Phone Number: +31622366387; Email: e.ooms@erasmusmc.nl
      • Contact: Inge van Loon, MSc; Phone Number: +31622366387; Email: i.g.vanloon@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)
• Signed informed consent

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will receive standard CR along with the RESST intervention, consisting of 5 on-site group sessions, focused on sleep and stress, integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy.	Behavioral: RESST; Subjects 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.
No Intervention: Control group; The control group will receive standard CR only. Standard CR programs consist of 6-12 weeks of twice-weekly supervised, group-based exercise sessions. In addition, educational sessions are provided, covering topics such as medical information, cardiovascular risk factors, adopting a heart-healthy lifestyle, and coping with emotions. Depending on the patient's specific needs, counselling sessions on stress management, smoking cessation, and healthy diet are available, and individual counselling can be provided by a social worker, dietician, or psychologist/psychiatrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectively assessed sleep duration	This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.	At baseline, after 3 months, and after 6 months.
Objectively assessed sleep-onset latency	This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.	At baseline, after 3 months, and after 6 months.
Objectively assessed wake after sleep onset	This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.	At baseline, after 3 months, and after 6 months.
Objectively assessed sleep efficiency	This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.	At baseline, after 3 months, and after 6 months.
Self-reported sleep quality	This will be measured with the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Score between 0-21, higher score indicates worse sleep quality.	At baseline, after 3 months, and after 6 months.
Perceived stress level	This will be measured with the Perceived Stress Scale-10 (PSS-10) questionnaire. Score between 0-40, higher score indicates higher perceived stress.	At baseline, after 3 months, and after 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol level	This will be measured by taking a hair sample. The amount of cortisol in the hair will be determined in a lab.	At baseline, after 3 months, and after 6 months.
Cortisone level	This will be measured by taking a hair sample. The amount of cortisone in the hair will be determined in a lab.	At baseline, after 3 months, and after 6 months.
Weight	Weight will be measured with a digital scale in kilograms.	At baseline, after 3 months, and after 6 months.
Height	Height will be measured with a stadiometer in centimeters.	At baseline.
Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	At baseline, after 3 months, and after 6 months.
Blood pressure	Blood pressure will be measured with a blood pressure monitor.	At baseline, after 3 months, and after 6 months.
Smoking behaviour	This will be measured with a carbon monoxide breath tester.	At baseline, after 3 months, and after 6 months.
Smoking behaviour	This will be measured with a self-designed questionnaire. The outcome of this questionnaire indicates whether a person smokes/has smoked in the past/does not smoke, what sort of tobacco is being smoked and how much the participant smokes.	At baseline, after 3 months, and after 6 months.
Muscle strength	Handgrip strength will be measured with a hand dynamometer.	At baseline, after 3 months, and after 6 months.
Physical activity	This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.	At baseline, after 3 months, and after 6 months.
Sedentary behaviour	This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.	At baseline, after 3 months, and after 6 months.
Alcohol use	This will be measured with the five-shot questionnaire. Score between 0-7, higher score indicates higher chance of alcohol overuse, misuse, and dependency.	At baseline, after 3 months, and after 6 months.
Health related quality of life	This will be measured with the MacNew questionnaire. Score between 1-7, higher score indicates higher health related quality of life.	At baseline, after 3 months, and after 6 months.
Health related quality of life	This will be measured with the EuroQol 5D/EQ5D questionnaire. Score between -0.446 - 1, higher score indicates a better health state. One subscale has a score between 0-100, higher score indicates better perceived health.	At baseline, after 3 months, and after 6 months.
Fatigue	This will be measured with the Fatigue Severity Scale (FSS) questionnaire. Score between 9-63, higher score indicates a greater fatigue severity.	At baseline, after 3 months, and after 6 months.
Daytime sleepiness	This will be measured with the Epworth Sleepiness Scale (ESS) questionnaire. Score between 0-24, higher score indicates a higher level of daytime sleepiness.	At baseline, after 3 months, and after 6 months.
Anxiety and depression	This will be measured with the Hospital Anxiety and Depression Scale (HADS) questionnaire. Score between 0-21 per subscale, higher score indicates severe symptoms of anxiety and depression.	At baseline, after 3 months, and after 6 months.
Participation in society	This will be measured with the USER-Participatie (USER-P) questionnare. Score between 0-100, higher score indicates higher participation in society.	At baseline, after 3 months, and after 6 months.
Estimated Cardiorespiratory fitness	This will be measured with the FitMáx©-Questionnaire. The outcome of this questionnaire is the estimated maximum oxygen uptake expressed in mL/kg/min. Higher score indicates better cardiorespiratory fitness.	At baseline, after 3 months, and after 6 months.
Presence of restless leg syndrome	This will be measured with the RLS rating scale questionnaire. Score between 0-28, higher score indicates more severe symptoms of restless leg syndrome.	At baseline.
Presence of insomnia	This will be measured with the Insomnia Severity Index (ISI) questionnaire. Score between 0-28, higher score indicates more severe insomnia complaints.	At baseline.
The risk of the presence of obstructive sleep apnoea	This will be measured with the STOP-bang questionnaire. Score between 0-8, higher score indicates higher risk of obstructive sleep apnoea.	At baseline.
Costs incurred by the patients	This will be measured with the IMTA Medical Consumption Questionnaire (IMCQ) which aims to determine costs within the health care system.	After 3 months and after 6 months.
Productivity costs	This will be measured with the IMTA Productivity Costs Questionnaire (IPCQ) which aims to determine the cost of productivity losses.	After 3 months and after 6 months.
Perceived sleep	This will be measured with the Sleep Consensus Diary for 7 days. The Sleep Consensus Diary consists of questions about the experience of sleep, what time the participant went to sleep, and how often the participant woke up.	At baseline, after 3 months, and after 6 months.
Momentary fatigue	This will be measured with an electronic diary.	At baseline, after 3 months, and after 6 months.
Momentary stress	This will be measured with an electronic diary.	At baseline, after 3 months, and after 6 months.
Adherence to the CR treatment and RESST intervention	This will be measured by recording the number of rehabilitation components attended, such as courses on nutrition or personal counseling.	After 3 months.
Treatment Satisfaction	This will be measured with a self-designed questionnaire and consists of questions about the applicability, clarity and logistics of the intervention.	After 3 months.
Sex	Female / male / other	At baseline.
Age	Age in years.	At baseline.
Cardiac diagnosis	Cardiac diagnosis as defined by ICD-10 that has resulted in referral to cardiac rehabilitation.	At baseline.
Educational level	Single-item question (high, middle, or low educated).	At baseline.
Relational status	Single-item question.	At baseline.
Cardiac risk factors	Presence of cardiac risk factors (family history, diabetes mellitus, hypertension, dyslipidemia, smoking prior to event).	At baseline.
Cardiac history	History of cardiovascular events and diseases.	At baseline.
Medication usage	Number of participants using a certain type of prescribed and/or over-the-counter medication.	At baseline, after 3 months, and after 6 months.
Comorbidity	Presence of other diseases.	At baseline.
Socioeconomic status	Socioeconomic status indicated by postal code.	At baseline.
Origin	Determined by birth country and parents' birth country.	At baseline.
Employment	Determined by employment status, and type of job.	At baseline.
Drug use	Drug use (yes/no) and drug classification.	At baseline.
Current/previous sleep disorder treatment	Description of current and previous treatment for sleeping disorders.	At baseline.
Diet	This will be measured with an electronic diary. Intake of caffeine and alcohol and timing of the main meal will be measured.	At baseline, after 3 months, and after 6 months.

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Maxima Medical Center; Capri Hartrevalidatie

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Stress; Sleep; Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NL86677.078.24; 10930012310027 (Other Identifier: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After termination of the study.
• IPD Sharing Access Criteria: The processed data will be made available in a repository. The Principal investigator can be contacted to request access to the data. Access to the data is evaluated by the OPTICARE RESST Consortium. If allowed based on the consortium agreement and the informed consent and when the intended methodology seems suitable data can be shared after signing of a DTA. Data will be further pseudonymized before sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No