OPTImizing CArdiac REhabilitation by REfining Sleep and STress and STress
- Conditions
- Cardiac RehabilitationCardiovascular Diseases
- Registration Number
- NCT06505109
- Lead Sponsor
- Erasmus Medical Center
- 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 (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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Objectively assessed sleep efficiency At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed sleep duration At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed wake after sleep onset At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Perceived stress level 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.
Objectively assessed sleep-onset latency At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Self-reported sleep quality 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.
- Secondary Outcome Measures
Name Time Method Health related quality of life 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.
Fatigue 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.
Daytime sleepiness 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.
Anxiety and depression 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.
Participation in society 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.
Estimated Cardiorespiratory fitness 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.
Presence of restless leg syndrome 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.
Presence of insomnia At baseline. This will be measured with the Insomnia Severity Index (ISI) questionnaire. Score between 0-28, higher score indicates more severe insomnia complaints.
The risk of the presence of obstructive sleep apnoea At baseline. This will be measured with the STOP-bang questionnaire. Score between 0-8, higher score indicates higher risk of obstructive sleep apnoea.
Costs incurred by the patients 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.
Productivity costs 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.
Perceived sleep 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.
Diet 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.
Momentary stress At baseline, after 3 months, and after 6 months. This will be measured with an electronic diary.
Adherence to the CR treatment and RESST intervention After 3 months. This will be measured by recording the number of rehabilitation components attended, such as courses on nutrition or personal counseling.
Treatment Satisfaction 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.
Sex At baseline. Female / male / other
Age At baseline. Age in years.
Cardiac diagnosis At baseline. Cardiac diagnosis as defined by ICD-10 that has resulted in referral to cardiac rehabilitation.
Educational level At baseline. Single-item question (high, middle, or low educated).
Relational status At baseline. Single-item question.
Cardiac risk factors At baseline. Presence of cardiac risk factors (family history, diabetes mellitus, hypertension, dyslipidemia, smoking prior to event).
Cardiac history At baseline. History of cardiovascular events and diseases.
Medication usage At baseline, after 3 months, and after 6 months. Number of participants using a certain type of prescribed and/or over-the-counter medication.
Comorbidity At baseline. Presence of other diseases.
Socioeconomic status At baseline. Socioeconomic status indicated by postal code.
Drug use At baseline. Drug use (yes/no) and drug classification.
Origin At baseline. Determined by birth country and parents' birth country.
Cortisol level 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.
Cortisone level 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.
Weight At baseline, after 3 months, and after 6 months. Weight will be measured with a digital scale in kilograms.
Height At baseline. Height will be measured with a stadiometer in centimeters.
Body Mass Index (BMI) At baseline, after 3 months, and after 6 months. Weight and height will be combined to report BMI in kg/m\^2.
Blood pressure At baseline, after 3 months, and after 6 months. Blood pressure will be measured with a blood pressure monitor.
Smoking behaviour 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.
Muscle strength At baseline, after 3 months, and after 6 months. Handgrip strength will be measured with a hand dynamometer.
Physical activity At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Sedentary behaviour At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Alcohol use 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.
Employment At baseline. Determined by employment status, and type of job.
Momentary fatigue At baseline, after 3 months, and after 6 months. This will be measured with an electronic diary.
Current/previous sleep disorder treatment At baseline. Description of current and previous treatment for sleeping disorders.
Trial Locations
- Locations (2)
Máxima Medisch Centrum
🇳🇱Eindhoven, North Brabant, Netherlands
Capri Hartrevalidatie
🇳🇱The Hague, South Holland, Netherlands
Máxima Medisch Centrum🇳🇱Eindhoven, North Brabant, NetherlandsEsmée Ooms, MScContact+31622366387e.ooms@erasmusmc.nlInge van Loon, MScContact+31622366387i.g.vanloon@erasmusmc.nl