Tokyo, Feb. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060550) titled 'A study on the effects of upper limb strength training in patients with heart failure' on Feb. 2.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Tohoku University
Condition:
Condition - Heart failure
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effectiveness of upper limb resistance training for patients with heart failure
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will be divided into two groups: one that performs upper and lower limb resistance training, and one that performs lower limb resistance training only, and will undergo rehabilitation for 2-3 weeks.
Interventions/Control_2 - The upper and lower limb resistance training group performed upper limb resistance training three times a week and lower limb resistance training on the other days.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Heart failure patients
2.Age and gender not specified
3.Written informed consent from the individual or legal representative to participate in this study
Key exclusion criteria - 1.Individuals who do not consent to this study.
2.Individuals with New York Heart Association (NYHA) classification IV.
3.Individuals who underwent invasive treatment during hospitalization (e.g.transcatheter aortic valve implantation, Mitra Clip, surgery).
4.Individuals with serious comorbidities or complications other than cardiac disease.
5.Individuals with severe dementia (Mini-Mental State Examination (MMSE) score<=10).
6.Individuals undergoing dialysis.
7.Individuals with severe limitations in upper and lower limb function due to neurological or orthopedic disorders.
8.Individuals undergoing cardiac rehabilitation for a prolonged period exceeding four weeks.
9.Individuals who required full assistance or close to full assistance in ADLs before hospitalization.
Target Size - 130
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 21 Day
Date of IRB - 2026 Year 01 Month 21 Day
Anticipated trial start date - 2026 Year 01 Month 21 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069261
Disclaimer: Curated by HT Syndication.