Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058955) titled 'Effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Konan Women's University
Condition:
Condition - Heart failure
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 1) Usual care
2) Exercise therapy (20-40 minutes per day, 5 days per week)
3) Cognitive training (20 minutes per day, 5 days per week)
4) Diet therapy, Disease management counseling, Vascular risk monitoring
Interventions/Control_2 - 1) Usual care
2) Exercise therapy (20-40 minutes per day, 5 days per week)
3) Diet therapy, Disease management counseling, Vascular risk monitoring
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients who were hospitalized for heart failure and conducted rehabilitation
2) Aged 65 years or older
3) Patient who were mild cognitive impairment (Japanese version of the Montreal Cognitive
Assessment: 17-22 points)
Key exclusion criteria - 1) Patients whose consent was not obtained
2) Acute coronary syndrome
3) Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy
4) Patients undergoing hemodialysis
5) Requiring high inotropic support
6) Patients with circulatory assist device
7) Short life expectancy due to advanced disease other than heart failure
8) Patients who could not walk without total assistance
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 08 Month 31 Day
Date of IRB - 2025 Year 08 Month 06 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067410
Disclaimer: Curated by HT Syndication.