Clinical Trial: Effects of inspiratory muscle training on respiratory function and quality of life after minimally invasive cardiac surgery: a single-center randomized controlled trial (Japan)

Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062253) titled 'Effects of inspiratory muscle training on respiratory function and quality of life after minimally invasive cardiac surgery' on July 16.

Study Type: Interventional

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

Primary Sponsor: Institute - Osaka International Medical & Science Center

Condition: Condition - Valvular heart disease or ischemic heart disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of inspiratory muscle training on respiratory function and quality of life in patients after minimally invasive cardiac surgery (MICS). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Inspiratory muscle training plus usual rehabilitation Interventions/Control_2 - Usual rehabilitation alone

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients scheduled to undergo elective minimally invasive cardiac surgery (MICS). 2. Men and women aged 18 years or older. 3. Patients who provide written informed consent. Key exclusion criteria - 1. Patients with preoperative dependence in activities of daily living (Barthel Index <100). 2. Patients with a history of chronic pulmonary disease. 3. Patients with a history of cerebrovascular disease accompanied by neurological deficits (e.g., motor paralysis). 4. Patients who develop major postoperative complications, such as myocardial infarction or cerebral infarction. 5. Patients who require reintubation or develop postoperative pulmonary complications. 6. Patients with dementia or psychiatric disorders that impair their ability to understand or perform inspiratory muscle training. Target Size - 54

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 18 Day Date of IRB - 2026 Year 06 Month 30 Day Anticipated trial start date - 2026 Year 07 Month 16 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=R000071233

Disclaimer: Curated by HT Syndication.