Clinical Trial: Feasibility of a Home-Based Phonation Task Program and Changes in Respiratory Muscle Strength in Community-Dwelling Older Adults: A Single-Arm Intervention Study (Japan)

Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063074) titled 'A study of whether older adults can continue a home voice practice program and how their breathing muscle strength changes' on Sept. 28.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Shonan University of Medical Sciences

Condition: Condition - Community-dwelling older adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the feasibility of a gamified home-based phonation task program (MeVox), in which participants control an on-screen character by voice intensity, and to describe changes in respiratory muscle strength in community-dwelling older adults. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - After a 2-week baseline period, participants perform a 6-week home-based phonation task program using a loaned Chromebook running a voice game application (MeVox). In each 20-s trial, participants control an on-screen character by voice intensity (louder to move up, softer to move down) to track a guide trajectory, and a tracking score (0-100) is displayed after each trial. The prescribed dose is at least 3 trials per day on at least 3 days per week. Physical therapists visit participants every 2 weeks at home or at a day-service facility to review performance, address barriers, and adjust task difficulty (hybrid model).

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - (1) Community-dwelling adults aged 65 years or older; (2) able to perform phonation practice at home using a Chromebook; (3) provided written informed consent. Key exclusion criteria - (1) Diagnosis of dementia; (2) presence of respiratory disease. Target Size - 6

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 11 Month 12 Day Date of IRB - 2024 Year 11 Month 12 Day Anticipated trial start date - 2024 Year 12 Month 02 Day Last follow-up date - 2025 Year 09 Month 18 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072202

Disclaimer: Curated by HT Syndication.