OPTImizing CArdiac REhabilitation by REfining Sleep and STress

NCT06505109 | Recruiting

• 2 other identifiers: NL86677.078.2410930012310027
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiovascular Diseases; Cardiac Rehabilitation

Keywords

Cardiovascular Diseases; Cardiac Rehabilitation; Sleep; Stress

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (44)

• Cortisol level

  At baseline, after 3 months, and after 6 months.

• Cortisone level

  At baseline, after 3 months, and after 6 months.

• Weight

  At baseline, after 3 months, and after 6 months.

• Height

  At baseline.

• Body Mass Index (BMI)

  At baseline, after 3 months, and after 6 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Máxima Medisch Centrum

Eindhoven, North Brabant, 5631BM, Netherlands

RECRUITING

Capri Hartrevalidatie

Rotterdam, South Holland, 3062MA, Netherlands

RECRUITING

Capri Hartrevalidatie

The Hague, South Holland, 2597AX, Netherlands

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Nienke ter Hoeve, PhD

CONTACT

+31107033190; n.terhoeve@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients are randomized to treatment or control.

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 17, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After termination of the study.
• 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.

Locations

NL (3)