Clinical Trial: Effects of Different Exercise Doses (4 and 8 kcal/kg body weight/week) on Body Weight, JKOM, and Skeletal Muscle Mass Index in Overweight Female Patients with Knee Osteoarthritis: A Three-Arm Randomized Controlled Trial Examining Dose-Response Relationships (Japan)

Tokyo, June 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062084) titled 'Effects of Different Exercise Doses on Body Weight and Patient-Reported Outcomes in Overweight Female Patients with Knee Osteoarthritis: Evaluation of Dose-Response Relationships Using a Randomized Controlled Trial' on June 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Dose comparison

Primary Sponsor: Institute - Teikyo Heisei University

Condition: Condition - Knee osteoarthritis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the effects of different exercise doses (physical therapy alone, physical therapy plus 4 kcal/kg body weight/week, and physical therapy plus 8 kcal/kg body weight/week) on body weight, the Japanese Knee Osteoarthritis Measure (JKOM), and skeletal muscle mass index (SMI) in overweight female patients with knee osteoarthritis, and to identify the optimal exercise dose. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Standardized physical therapy only: range of motion exercises for hip and knee joints, strengthening exercises mainly for quadriceps and hip abductors, balance training, basic movement training, and activities of daily living training, twice weekly for 12 weeks. Interventions/Control_2 - Standard physical therapy plus cycle ergometer exercise at 4 kcal/kg body weight/week. Exercise dose was gradually increased from 1 kcal/kg/week by 1 kcal/kg/week per week, reaching 4 kcal/kg/week at week 4 and maintained thereafter. Twice weekly for 12 weeks.

Eligibility: Age-lower limit - 50 years-old = Gender - Female Key inclusion criteria - Female, aged 50 years or older, medial knee osteoarthritis, BMI 24 kg/m2 or higher, Kellgren-Lawrence classification Grade 2 or 3 Key exclusion criteria - Lateral knee osteoarthritis, history of total hip or knee arthroplasty, history of myocardial infarction, angina, or arrhythmia, rheumatoid arthritis, history of knee fracture or malignancy, difficulty walking independently, dementia, history of central nervous system disease, or severe illness precluding exercise participation Target Size - 48

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 07 Month 06 Day Date of IRB - 2024 Year 08 Month 19 Day Anticipated trial start date - 2025 Year 02 Month 03 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071029

Disclaimer: Curated by HT Syndication.