Tokyo, Nov. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059898) titled 'Evaluation of the Safety and Efficacy of a Remote Rehabilitation Program for Older Adults with Frailty or Prefrailty' on Nov. 27.

Study Type: Interventional

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

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Frailty or Pre frailty Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to compare a remote rehabilitation program with self-directed training consisting of exercise instruction alone in older adults with frailty or prefrailty, and to evaluate the safety and efficacy of the remote rehabilitation program through a randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention group: Participants receive remote rehabilitation once per week using a tablet device and video communication (FaceTime or Skype). Vital signs are measured prior to exercise to confirm safety. Patients also perform home-based exercises using provided instructional videos.

Common procedures: Both groups undergo activity monitoring using a wearable device (Fitbit). Randomization is conducted using a stratified permuted block method with BMI as the stratification factor, implemented through an Interactive Web Response System (IWRS; RedCAP). Interventions/Control_2 - Control group: Participants perform self-directed training based only on exercise instruction. Exercise adherence is reviewed during routine outpatient visits, and additional instruction is provided as needed.

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Regularly attending outpatient clinics in the relevant departments 2.Over 65 years old 3.Able to walk independently (including with a cane) 4.Provided written informed consent 5.Living with a cohabiting family member Key exclusion criteria - 1.Unable to walk independently or unable to complete interviews/questionnaires 2.Severe cerebrovascular, cardiac, respiratory, hepatic, renal, gastrointestinal, or endocrine/metabolic disease 3.Estimated life expectancy is less than one year due to malignancy or other conditions 4.Severe physical disability requiring long-term rehabilitation 5.Deemed ineligible for participation by the attending physician Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2023 Year 12 Month 25 Day Date of IRB - 2024 Year 04 Month 25 Day Anticipated trial start date - 2024 Year 09 Month 01 Day Last follow-up date - 2025 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068501

Disclaimer: Curated by HT Syndication.