Clinical Trial: A Randomized Feasibility Trial of Inspiratory Muscle Training Combined with Oral Nutritional Supplementation in Patients with Chronic Obstructive Pulmonary Disease (Japan)

Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062438) titled 'Effects of Inspiratory Muscle Training Combined with Nutritional Intervention in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Feasibility Trial' on Aug. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Nagasaki University

Condition: Condition - chronic obstructive pulmonary diseases Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the preliminary effects of inspiratory muscle training (IMT) alone and IMT combined with oral nutritional supplementation (ONS) on respiratory muscle strength and respiratory muscle mass in patients with chronic obstructive pulmonary disease (COPD). Basic objectives2 - Others

Intervention: Interventions/Control_1 - Inspiratory muscle training (30 breaths per session, twice daily for 6 weeks) combined with oral nutritional supplementation (one serving of Rehab Time Jelly once daily after inspiratory muscle training for 6 weeks) Interventions/Control_2 - Inspiratory muscle training (30 breaths per session, twice daily for 6 weeks).

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - Patients with moderate to severe chronic obstructive pulmonary disease (COPD) receiving outpatient pulmonary rehabilitation at participating institutions. Clinically stable under standard medical treatment. Able and willing to provide written informed consent. Key exclusion criteria - 1.Patients unable to assume the supine position for diaphragmatic ultrasonography or with comorbid conditions affecting diaphragmatic movement. 2.Patients who experienced an acute exacerbation within 4 weeks prior to enrollment. 3.Patients judged by the attending physician to be unable or unsuitable to perform inspiratory muscle training (IMT). 4.Patients unable to consume oral nutritional supplements because of allergy or dysphagia. 5.Patients whose clinical condition is expected to change during the study period, making study participation difficult. 6.Patients who had been performing inspiratory muscle training before study enrollment. 7.Patients considered unsuitable for participation by the attending physician or the principal investigator. Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 03 Month 19 Day Date of IRB - 2026 Year 04 Month 28 Day Anticipated trial start date - 2026 Year 08 Month 11 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=R000071457

Disclaimer: Curated by HT Syndication.