Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06505109

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Máxima Medisch Centrum, Eindhoven, North Brabant, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RESST

Behavioral

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.

Primary outcomes

  1. Objectively assessed sleep duration

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.

  2. Objectively assessed sleep-onset latency

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.

  3. Objectively assessed wake after sleep onset

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.

  4. Objectively assessed sleep efficiency

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.

  5. Self-reported sleep quality

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Score between 0-21, higher score indicates worse sleep quality.

  6. Perceived stress level

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with the Perceived Stress Scale-10 (PSS-10) questionnaire. Score between 0-40, higher score indicates higher perceived stress.

Secondary outcomes

  1. Cortisol level

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured by taking a hair sample. The amount of cortisol in the hair will be determined in a lab.

  2. Cortisone level

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured by taking a hair sample. The amount of cortisone in the hair will be determined in a lab.

  3. Weight

    Time frame: At baseline, after 3 months, and after 6 months.

    Weight will be measured with a digital scale in kilograms.

  4. Height

    Time frame: At baseline.

    Height will be measured with a stadiometer in centimeters.

  5. Body Mass Index (BMI)

    Time frame: At baseline, after 3 months, and after 6 months.

    Weight and height will be combined to report BMI in kg/m^2.

  6. Blood pressure

    Time frame: At baseline, after 3 months, and after 6 months.

    Blood pressure will be measured with a blood pressure monitor.

  7. Smoking behaviour

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with a carbon monoxide breath tester.

  8. Smoking behaviour

    Time frame: At baseline, after 3 months, and after 6 months.

    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.

  9. Muscle strength

    Time frame: At baseline, after 3 months, and after 6 months.

    Handgrip strength will be measured with a hand dynamometer.

  10. Physical activity

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.

  11. Sedentary behaviour

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.

  12. Alcohol use

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with the five-shot questionnaire. Score between 0-7, higher score indicates higher chance of alcohol overuse, misuse, and dependency.

  13. Health related quality of life

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with the MacNew questionnaire. Score between 1-7, higher score indicates higher health related quality of life.

  14. Health related quality of life

    Time frame: At baseline, after 3 months, and after 6 months.

    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.

  15. Fatigue

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with the Fatigue Severity Scale (FSS) questionnaire. Score between 9-63, higher score indicates a greater fatigue severity.

  16. Daytime sleepiness

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with the Epworth Sleepiness Scale (ESS) questionnaire. Score between 0-24, higher score indicates a higher level of daytime sleepiness.

  17. Anxiety and depression

    Time frame: At baseline, after 3 months, and after 6 months.

    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.

  18. Participation in society

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with the USER-Participatie (USER-P) questionnare. Score between 0-100, higher score indicates higher participation in society.

  19. Estimated Cardiorespiratory fitness

    Time frame: At baseline, after 3 months, and after 6 months.

    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.

  20. Presence of restless leg syndrome

    Time frame: At baseline.

    This will be measured with the RLS rating scale questionnaire. Score between 0-28, higher score indicates more severe symptoms of restless leg syndrome.

  21. Presence of insomnia

    Time frame: At baseline.

    This will be measured with the Insomnia Severity Index (ISI) questionnaire. Score between 0-28, higher score indicates more severe insomnia complaints.

  22. The risk of the presence of obstructive sleep apnoea

    Time frame: At baseline.

    This will be measured with the STOP-bang questionnaire. Score between 0-8, higher score indicates higher risk of obstructive sleep apnoea.

  23. Costs incurred by the patients

    Time frame: After 3 months and after 6 months.

    This will be measured with the IMTA Medical Consumption Questionnaire (IMCQ) which aims to determine costs within the health care system.

  24. Productivity costs

    Time frame: After 3 months and after 6 months.

    This will be measured with the IMTA Productivity Costs Questionnaire (IPCQ) which aims to determine the cost of productivity losses.

  25. Perceived sleep

    Time frame: At baseline, after 3 months, and after 6 months.

    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.

  26. Diet

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with an electronic diary. Intake of caffeine and alcohol and timing of the main meal will be measured.

  27. Momentary fatigue

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with an electronic diary.

  28. Momentary stress

    Time frame: At baseline, after 3 months, and after 6 months.

    This will be measured with an electronic diary.

  29. Adherence to the CR treatment and RESST intervention

    Time frame: After 3 months.

    This will be measured by recording the number of rehabilitation components attended, such as courses on nutrition or personal counseling.

  30. Treatment Satisfaction

    Time frame: After 3 months.

    This will be measured with a self-designed questionnaire and consists of questions about the applicability, clarity and logistics of the intervention.

  31. Sex

    Time frame: At baseline.

    Female / male / other

  32. Age

    Time frame: At baseline.

    Age in years.

  33. Cardiac diagnosis

    Time frame: At baseline.

    Cardiac diagnosis as defined by ICD-10 that has resulted in referral to cardiac rehabilitation.

  34. Educational level

    Time frame: At baseline.

    Single-item question (high, middle, or low educated).

  35. Relational status

    Time frame: At baseline.

    Single-item question.

  36. Cardiac risk factors

    Time frame: At baseline.

    Presence of cardiac risk factors (family history, diabetes mellitus, hypertension, dyslipidemia, smoking prior to event).

  37. Cardiac history

    Time frame: At baseline.

    History of cardiovascular events and diseases.

  38. Medication usage

    Time frame: At baseline, after 3 months, and after 6 months.

    Number of participants using a certain type of prescribed and/or over-the-counter medication.

  39. Comorbidity

    Time frame: At baseline.

    Presence of other diseases.

  40. Socioeconomic status

    Time frame: At baseline.

    Socioeconomic status indicated by postal code.

  41. Origin

    Time frame: At baseline.

    Determined by birth country and parents' birth country.

  42. Employment

    Time frame: At baseline.

    Determined by employment status, and type of job.

  43. Drug use

    Time frame: At baseline.

    Drug use (yes/no) and drug classification.

  44. Current/previous sleep disorder treatment

    Time frame: At baseline.

    Description of current and previous treatment for sleeping disorders.

Study contacts

Contact information is provided by the study sponsor or research team.

Nienke ter Hoeve, PhD

CONTACT

[email protected]

+31107033190

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

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

Registry information

Acronym: OPTICARE-RESST

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.