Clinical Trial: Effect of static stretching exercise intervention on walking ability and quality of life in patients with lower limb arterial disease Prospective, randomized, open-label, parallel-group, delayed-release study (Japan)

Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060445) titled 'Effect of static stretching exercise intervention on walking ability and quality of life in patients with lower limb arterial disease Prospective, randomized, open-label, parallel-group, delayed-release study' on Jan. 30.

Study Type: Interventional

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

Primary Sponsor: Institute - Juntendo University

Condition: Condition - lower limb arterial disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study was to examine the extent to which exercise intervention using static stretching significantly improves walking ability, physical function, and quality of life in patients with LEAD compared with conventional CR, which focuses on aerobic exercise. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - A static stretching program will be performed at home for a total of 30 minutes per day, three times a week for 12 weeks. Stretching will be performed using an ankle dorsiflexion splint , targeting the triceps surae. At the first intervention, the principal investigator will explain the procedure and visually check the attachment of the device to ensure safety. Patients will be contacted by phone at weeks 1, 2, 6, and 12 to confirm the implementation status and whether the stretches are being performed effectively. After the 12-week period, supervised CR will be implemented immediately. Interventions/Control_2 - Patients are instructed to perform standard CR programs (such as treadmill walking) at least once per week, aiming for a total of three exercise therapy sessions per week including unsupervised sessions. Exercise status during unsupervised sessions is confirmed by CR staff at each visit.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Age 20 or older 2.Patients with intermittent claudication and a physician's diagnosis of LEAD 3.ABI < 0.9 4.Participants must have received a thorough explanation of this study and provided written informed consent. 5.Participants must be able to undergo static stretching and be available for regular daytime phone calls. Key exclusion criteria - 1.Individuals under the age of 20 2.Individuals deemed unsuitable for participation in this study by their attending physician 3.Individuals with complications contraindicating exercise or considered to be at high risk for exercise. 4.Individuals deemed otherwise unsuitable as research subjects by the principal investigator 5.Among the research subjects described in 1 above, eligibility is determined by satisfying all selection criteria in 2 and not meeting any exclusion criteria in 3. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 30 Day Anticipated trial start date - 2026 Year 03 Month 31 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=R000069152

Disclaimer: Curated by HT Syndication.