OPTImizing CArdiac REhabilitation by REfining Sleep and STress

Overview

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.

Interventions

• 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.

Primary outcome measures

• Objectively assessed sleep duration [Time frame: At baseline, after 3 months, and after 6 months.]
• Objectively assessed sleep-onset latency [Time frame: At baseline, after 3 months, and after 6 months.]
• Objectively assessed wake after sleep onset [Time frame: At baseline, after 3 months, and after 6 months.]
• Objectively assessed sleep efficiency [Time frame: At baseline, after 3 months, and after 6 months.]
• Self-reported sleep quality [Time frame: At baseline, after 3 months, and after 6 months.]
• Perceived stress level [Time frame: At baseline, after 3 months, and after 6 months.]

Secondary outcome measures (12)

• Cortisol level [Time frame: At baseline, after 3 months, and after 6 months.]
• Cortisone level [Time frame: At baseline, after 3 months, and after 6 months.]
• Weight [Time frame: At baseline, after 3 months, and after 6 months.]
• Height [Time frame: At baseline.]
• Body Mass Index (BMI) [Time frame: At baseline, after 3 months, and after 6 months.]
• Blood pressure [Time frame: At baseline, after 3 months, and after 6 months.]
• Smoking behaviour [Time frame: At baseline, after 3 months, and after 6 months.]
• Smoking behaviour [Time frame: At baseline, after 3 months, and after 6 months.]
• Muscle strength [Time frame: At baseline, after 3 months, and after 6 months.]
• Physical activity [Time frame: At baseline, after 3 months, and after 6 months.]
• Sedentary behaviour [Time frame: At baseline, after 3 months, and after 6 months.]
• Alcohol use [Time frame: At baseline, after 3 months, and after 6 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 3 centers

• Máxima Medisch Centrum — Eindhoven
• Capri Hartrevalidatie — Rotterdam
• Capri Hartrevalidatie — The Hague

Publications

• van Loon I, Ooms E, Luik A, Sunamura M, Wally T, Boersma E, Vromen T, Tenbult-van Limpt N, Bussmann H, Boon M, Louter M, Redekop K, Ista E, van den Berg-Emons R, Ter Hoeve N; other OPTICARE-RESST Consortium members. Optimising sleep and managing stress by integrating a behavioural intervention during cardiac rehabilitation: rationale and design of the OPTICARE-RESST multicentre randomised controll PMID 41991268

Identifiers

NCT: NCT06505109 · NL86677.078.24 · 10930012310027

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗