Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061956) titled 'Effects of Monthly Exercise Guidance in Elderly Patients with Heart Failure' on July 1.
Study Type:
Observational
Primary Sponsor:
Institute - Minamino Cardiovascular Hospital
Condition:
Condition - Heart failure
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Exercise therapy is recommended after discharge for older patients with heart failure; however, participation in outpatient cardiac rehabilitation remains limited. The purpose of this prospective study is to investigate the effects of a low-frequency exercise guidance program consisting of monthly exercise counseling on physical function, daily functioning, life-space mobility, health-related quality of life, psychological status, and clinical outcomes in elderly patients with heart failure. In participants with family caregivers, caregiver burden will also be explored. In addition, a predefined subgroup analysis will be performed in patients with a discharge Short Physical Performance Battery (SPPB) score of 10 or lower.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 65 years or older with heart failure
2. Patients discharged home after hospitalization for heart failure
3. Ability to attend outpatient visits
4. Patients who received outpatient exercise guidance
Key exclusion criteria - 1. Contraindication to exercise therapy determined by the attending physician
2. Severe cognitive impairment preventing study assessment
3. Expected difficulty in completing follow-up
4. Any condition judged by the investigators to make participation inappropriate
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 01 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2030 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070743
Disclaimer: Curated by HT Syndication.
