Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505109
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
OPTImizing CArdiac REhabilitation by REfining Sleep and STress
Sponsor:
None
Organization:
None
Study Overview
Official Title:
OPTImizing CArdiac REhabilitation by REfining Sleep and STress
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTICARE-RESST
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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None