Clinical Trial: A Randomized Controlled Trial of Step-Count-Targeted Physical Therapy for the Prevention of Hospital-Associated Disability in Elderly Patients After Cardiovascular Surgery (Japan)

Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060418) titled 'Effect of Step-Count-Targeted Physical Therapy on Prevention of Hospital-Associated Disability in Elderly Patients After Cardiovascular Surgery: A Randomized Controlled Trial.' on Jan. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Gunma Prefectural Cardiovascular Center, Department of Rehabilitation

Condition: Condition - Cardiovascular Diseases Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to investigate whether step-count-targeted physical therapy is effective in preventing hospital-associated disability in elderly patients after cardiovascular surgery.in addition, this study aims to examine whether the effectiveness of the intervention differs according to the degree of surgical invasiveness, including open-heart surgery, minimally invasive cardiac surgery (MICS), transcatheter aortic valve replacement (TAVR), and transcatheter edge-to-edge repair(TEER). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention group step count targeted physical therapy: Participants in the intervention group will receive step count targeted physical therapy in addition to standard physical therapy. The intervention period will start when postoperative walking training is initiated and the participant becomes able to perform independent standing exercises and will continue until hospital discharge. Participants will wear a triaxial accelerometer based activity monitor throughout the day except during bathing. The display of the activity monitor will be turned on so that participants can check their daily step counts. The initial daily step count target will be nine hundred steps or more. Participants who achieve this target will subsequently be encouraged to reach a higher target of one thousand three hundred eight steps or more. articipants will be instructed to perform self directed exercise every day consisting of walking practice or stepping in place when independent walking is not permitted. Daily step counts will be recorded by the participants every night on a step count log sheet. A physical therapist will review the recorded step counts at least once per day during routine physical therapy sessions and will provide encouragement positive feedback and specific guidance to support achievement of the daily step target. Exercise intensity will be prescribed at a Borg rating of perceived exertion level between eleven and thirteen. If any safety related symptoms occur the intervention will be temporarily discontinued and resumption will be considered after clinical stabilization. Interventions/Control_2 - Control group standard physical therapy: Participants in the control group will receive standard physical therapy alone according to institutional practice. They will wear the same activity monitor but the display will be turned off and no feedback regarding step counts or physical activity will be provided.

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - 1.Patients hospitalized at the study institution who are prescribed physical therapy by a physician 2.Patients scheduled to undergo elective open-heart surgery, minimally invasive cardiac surgery (MICS), transcatheter aortic valve replacement (TAVR), or transcatheter edge-to-edge repair (TEER) 3.Aged 65 years or older 4.Patients who have undergone a preoperative physical therapy assessment 5.Patients who have provided written informed consent to participate in the study Key exclusion criteria - 1 Patients who underwent emergency surgery 2 Patients with delayed extubation lasting more than forty eight hours 3 Patients with preoperative cognitive impairment defined as a Mini Mental State Examination score of twenty three or lower 4 Patients with preoperative functional dependency defined as a Barthel Index score of less than eighty five or a Functional Independence Measure score of less than eighty eight 5 Patients who developed postoperative cerebral infarction 6 Patients with uncontrolled arrhythmias or uncontrolled hypertension 7 Patients judged to be unsuitable for study participation by the principal investigator Target Size - 160

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 05 Day Anticipated trial start date - 2026 Year 01 Month 25 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068843

Disclaimer: Curated by HT Syndication.