Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058952) titled 'Development of a nursing care program utilizing cardiac rehabilitation for acute-phase patients after open heart surgery' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - DOKKYO MEDICAL UNIVERSITY
Condition:
Condition - ischemic heart disease
heart valve disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - By developing and implementing a nursing care program that utilizes the perspective of cardiac rehabilitation, we will prevent complications during the acute phase following open heart surgery and support early mobilization. We will then verify whether this program shortens the time to independent walking and the length of hospital stay compared to the non-intervention group.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Implement the developed nursing care program.
Interventions/Control_2 - The non-intervention group will undergo retrospective investigation.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Patients undergoing elective cardiac surgery in cardiovascular surgery
(2) Patients who voluntarily agreed to participate in the study
(3) Patients who are independent in their activities of daily living (ADL) prior to surgery (those who fall under ADL rank J).
Key exclusion criteria - (1) Patients without symptoms of mental illness, delirium, dementia, etc.
(2) Patients who are not able to walk independently prior to surgery
(3) Patients wearing a circulatory assist device
(4) Patients undergoing noninvasive positive pressure ventilation for the treatment of heart failure
(5) Excluding pediatric patients
(6) Patients who were unable to walk independently during their hospital stay
Target Size - 170
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Date of IRB - 2025 Year 08 Month 22 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067421
Disclaimer: Curated by HT Syndication.