OPTImizing CArdiac REhabilitation by REfining Sleep and STress
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Objectively assessed sleep efficiency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention group
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.
干预措施: RESST (Behavioral)
Control group
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.
结局指标
主要结局
Objectively assessed sleep efficiency
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Blood pressure(At baseline, after 3 months, and after 6 months.)
- Muscle strength(At baseline, after 3 months, and after 6 months.)
- Physical activity(At baseline, after 3 months, and after 6 months.)
- Sedentary behaviour(At baseline, after 3 months, and after 6 months.)
- Alcohol use(At baseline, after 3 months, and after 6 months.)
- Fatigue(At baseline, after 3 months, and after 6 months.)
- Daytime sleepiness(At baseline, after 3 months, and after 6 months.)
- Anxiety and depression(At baseline, after 3 months, and after 6 months.)
- Participation in society(At baseline, after 3 months, and after 6 months.)
- Estimated Cardiorespiratory fitness(At baseline, after 3 months, and after 6 months.)
- Presence of restless leg syndrome(At baseline.)
- Presence of insomnia(At baseline.)
- The risk of the presence of obstructive sleep apnoea(At baseline.)
- Costs incurred by the patients(After 3 months and after 6 months.)
- Productivity costs(After 3 months and after 6 months.)
- Perceived sleep(At baseline, after 3 months, and after 6 months.)
- Diet(At baseline, after 3 months, and after 6 months.)
- Momentary fatigue(At baseline, after 3 months, and after 6 months.)
- Momentary stress(At baseline, after 3 months, and after 6 months.)
- Adherence to the CR treatment and RESST intervention(After 3 months.)
- Treatment Satisfaction(After 3 months.)
- Sex(At baseline.)
- Age(At baseline.)
- Cardiac diagnosis(At baseline.)
- Educational level(At baseline.)
- Relational status(At baseline.)
- Cardiac risk factors(At baseline.)
- Cardiac history(At baseline.)
- Medication usage(At baseline, after 3 months, and after 6 months.)
- Comorbidity(At baseline.)
- Socioeconomic status(At baseline.)
- Origin(At baseline.)
- Employment(At baseline.)
- Drug use(At baseline.)
- Current/previous sleep disorder treatment(At baseline.)
- Smoking behaviour(At baseline, after 3 months, and after 6 months.)
- Health related quality of life(At baseline, after 3 months, and after 6 months.)
研究者
N. (Nienke) ter Hoeve PhD
Principal Investigator
Erasmus Medical Center