Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062624) titled 'Effects of an Activity Monitor-Based Discharge Support Program on Physical Activity in Older Patients with Heart Failure After Hospital Discharge' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Ibaraki Prefectural University
Condition:
Condition - Heart Failure
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to determine the effects of an activity monitor-based discharge support program on physical activity after hospital discharge in older patients with heart failure, compared with usual discharge support.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants in the intervention group will receive an activity monitor-based discharge support program during hospitalization. The program will be provided once, for approximately 20 minutes, after the participant has been weaned from catecholamine agents or has become able to walk. The program will include individualized feedback on physical activity data obtained from an activity monitor, goal setting based on the participant's current physical activity level and resting heart rate, and behavioral planning to promote physical activity after hospital discharge. Participants will receive guidance on walking and simple resistance exercises, such as squats and calf raises, and will be encouraged to self-monitor their physical activity. The intervention will be provided in addition to usual cardiac rehabilitation and discharge support.
Interventions/Control_2 - Participants in the control group will receive usual cardiac rehabilitation and standard discharge support during hospitalization. Standard discharge support will include general guidance on heart failure management, medication adherence, diet, exercise, and daily activities according to routine clinical practice and the cardiac rehabilitation guidelines. No activity monitor-based individualized feedback or additional behavioral planning will be provided.
Eligibility:
Age-lower limit - 65
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients will be eligible for this study if they are aged 65 years or older, have been admitted to our hospital due to acute exacerbation of heart failure, are eligible for cardiovascular rehabilitation, and have been prescribed rehabilitation by a physician.
In accordance with the guidelines for cardiac rehabilitation, eligible patients must be hemodynamically stable and have been cleared to participate in exercise therapy. In addition, participants must be able to understand the study procedures, be able to participate in the discharge support program, and provide written informed consent to participate in the study.
Key exclusion criteria - 1. Patients who meet any of the contraindications to exercise therapy specified in the Guidelines for Cardiac Rehabilitation.
2. Patients who have difficulty walking and are unable to undergo physical activity assessment. The use of walking aids and partially assisted walking are permitted.
3. Patients classified as New York Heart Association (NYHA) functional class IV.
4. Patients with suspected cognitive impairment (Mini-Cog score <2).
5. Patients who are unable to provide informed consent to participate in this study.
6. Patients for whom continued participation in the study is deemed difficult due to medical reasons or other circumstances after study initiation.
7. Patients who die during hospitalization.
Target Size - 52
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 01 Day
Anticipated trial start date - 2026 Year 10 Month 01 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=R000071687
Disclaimer: Curated by HT Syndication.
