Clinical trial NCT06505109: OPTImizing CArdiac REhabilitation by REfining Sleep and STress
Official title: OPTImizing CArdiac REhabilitation by REfining Sleep and STress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cardiac Rehabilitation
Keywords: Cardiovascular Diseases
Cardiac Rehabilitation
Sleep
Stress
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Capri Hartrevalidatie
name: Maxima Medical Center
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to treatment or control.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Objectively assessed sleep duration
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Objectively assessed sleep-onset latency
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Objectively assessed wake after sleep onset
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Objectively assessed sleep efficiency
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Self-reported sleep quality
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Perceived stress level
timeFrame: At baseline, after 3 months, and after 6 months.
Secondary outcomes:
measure: Cortisol level
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Cortisone level
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Weight
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Height
timeFrame: At baseline.
measure: Body Mass Index (BMI)
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Blood pressure
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Smoking behaviour
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Smoking behaviour
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Muscle strength
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Physical activity
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Sedentary behaviour
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Alcohol use
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Health related quality of life
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Health related quality of life
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Fatigue
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Daytime sleepiness
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Anxiety and depression
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Participation in society
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Estimated Cardiorespiratory fitness
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Presence of restless leg syndrome
timeFrame: At baseline.
measure: Presence of insomnia
timeFrame: At baseline.
measure: The risk of the presence of obstructive sleep apnoea
timeFrame: At baseline.
measure: Costs incurred by the patients
timeFrame: After 3 months and after 6 months.
measure: Productivity costs
timeFrame: After 3 months and after 6 months.
measure: Perceived sleep
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Diet
timeFrame: At baseline and after 3 months.
measure: Momentary fatigue
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Momentary stress
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Adherence to the CR treatment and RESST intervention
timeFrame: After 3 months.
measure: Treatment Satisfaction
timeFrame: After 3 months.
measure: Sex
timeFrame: At baseline.
measure: Age
timeFrame: At baseline.
measure: Cardiac diagnosis
timeFrame: At baseline.
measure: Educational level
timeFrame: At baseline.
measure: Relational status
timeFrame: At baseline.
measure: Cardiac risk factors
timeFrame: At baseline.
measure: Cardiac history
timeFrame: At baseline.
measure: Medication usage
timeFrame: At baseline, after 3 months, and after 6 months.
measure: Comorbidity
timeFrame: At baseline.
measure: Socioeconomic status
timeFrame: At baseline.
measure: Origin
timeFrame: At baseline.
measure: Employment
timeFrame: At baseline.
measure: Drug use
timeFrame: At baseline.
measure: Current/previous sleep disorder treatment
timeFrame: At baseline.
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Máxima Medisch Centrum
state: North Brabant
city: Rotterdam
country: Netherlands
facility: Capri Hartrevalidatie
state: South Holland
city: The Hague
country: Netherlands
facility: Capri Hartrevalidatie
state: South Holland
Study officials:
References: