Clinical Trial: Effects of Neuromuscular Electrical Stimulation and Pollock Protein on Lower Limb Muscle Strength in Elderly Hospitalized Patients (Japan)

Tokyo, June 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061888) titled 'Effects of Neuromuscular Electrical Stimulation and Pollock Protein on Lower Limb Muscle Strength in Elderly Hospitalized Patients' on June 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Kansai Medical University

Condition: Condition - Patients admitted to the Community Comprehensive Care Unit Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine the effects of Neuromuscular Electrical Stimulation (NMES) combined with Alaska Pollack Protein (APP) on lower limb muscle strength in elderly hospitalized patients. Elderly patients admitted to the Community Comprehensive Care Unit were divided into three groups: a group receiving regular rehabilitation including NMES (regular rehabilitation group, NMES group), a group receiving regular rehabilitation plus NMES and whey protein (whey group), and a group receiving regular rehabilitation plus NMES and APP (APP group) for 6 weeks. The changes in muscle strength before and after 6 weeks will be compared. In addition, body composition, walking ability, grip strength, balance ability, nutritional status, and oral and swallowing function will be evaluated as secondary outcomes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Conventional rehabilitation for 6 weeks Interventions/Control_2 - Neuromuscular electrical stimulation (30 min/day, 5 times/week) in addition to conventional rehabilitation for 6 weeks

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - 1) Participants who are eligible for oral intake of food (regardless of whether or not they are able to eat independently) 2) Participants who have been fully informed about their participation in this study, and who have given written consent of their own free will based on their full understanding of the study Key exclusion criteria - The participants who fall into any of the following criteria will not be included in this study. 1) Participants with food allergies to dairy products, fish, eggs, wheat, soybeans, etc. 2) Participants with restricted protein intake 3) Participants who have an electronic device inserted in the body, such as a pacemaker, that can be affected by electrical stimulation of NMES 4) Participants with severe sensory impairment 5) Participants with progressive neuromuscular diseases 6) Participants with malignant tumors 7) Participants with a history of peripheral nerve disease of the lower limb 8) Participants with a history of cerebrovascular disease (Brunnstrome stage < V of the lower limb ) 9) Participants who have been instructed by a physician to limit their activities, such as not-bearing or bed rest 10) Participants who are judged by the research director to be inappropriate to participate in the study for reasons other than those listed above Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 06 Month 22 Day Anticipated trial start date - 2024 Year 06 Month 26 Day Last follow-up date - 2027 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062435

Disclaimer: Curated by HT Syndication.