Clinical Trial: Acute Effects of Combined Intermittent Pneumatic Compression and Stretching on Lower-Limb Flexibility and Perceived Fatigue in Healthy University Students: A Randomized Crossover Trial (Japan)

Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062987) titled 'Effects of Pneumatic Compression Boots and Stretching on Lower-Limb Flexibility and Perceived Fatigue in Healthy University Students' on Sept. 24.

Study Type: Interventional

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

Primary Sponsor: Institute - Niigata University of Health and Welfare

Condition: Condition - Healthy university students Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare the immediate effects of stretching alone, intermittent pneumatic compression (IPC) alone, and combined IPC and stretching on knee extension range of motion, perceived fatigue, muscle soreness, and thigh and calf circumferences in healthy male and female university students. Each participant will complete all three conditions in a randomized order, with an interval of at least 7 days between sessions. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Combined IPC-and-stretching condition. Participants will remain in the supine position and receive 20 minutes of intermittent pneumatic compression to both lower limbs using SOMANO Recovery Boots (Montreux Co., Ltd., Japan). The pressure and operating mode will be selected from the device settings before study initiation and standardized across all participants and conditions involving IPC. During IPC, the researcher will administer passive stretching to the hamstrings and gastrocnemius muscles of both lower limbs. Joint positions, stretching intensity, stretching duration, and rest intervals will be identical to those used in the stretching-alone condition. Interventions/Control_2 - Stretching-alone condition. With the participant in the supine position, the researcher will administer passive stretching to the hamstrings and gastrocnemius muscles of both lower limbs for a total of 20 minutes. For the hamstrings, the knee will be passively extended while the hip is maintained at 90 degrees of flexion. For the gastrocnemius, the ankle will be passively dorsiflexed while the hip and knee are maintained at 0 degrees. Stretching intensity will be adjusted according to participant feedback to produce a clear but non-painful stretching sensation. For each muscle group, the right and left legs will each be stretched for 1 minute in succession, followed by a 30-second rest period. One cycle comprising stretching of both the hamstrings and gastrocnemius muscles will last 5 minutes, and four cycles will be performed.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1 University students aged 18 to 23 years enrolled at Niigata University of Health and Welfare 2 Individuals who understand the study and provide written informed consent 3 Individuals who can attend three sessions separated by at least 7 days Key exclusion criteria - 1 Individuals who have sustained a lower-limb injury or developed a lower-limb musculoskeletal disorder within the previous 3 months, or who currently have lower-limb pain severe enough to interfere with the assessments or interventions, swelling, skin lesions, or signs of infection. 2 Individuals with a circulatory disorder or another condition that prevents IPC from being administered safely. 3 Individuals with impaired sensation in the lower limbs or another condition that prevents them from appropriately reporting their responses to pneumatic compression. 4 Individuals judged by the principal investigator, following medical history screening and safety assessment, to be unable to safely complete the assessments or interventions. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 11 Month 20 Day Anticipated trial start date - 2026 Year 12 Month 01 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=R000072107

Disclaimer: Curated by HT Syndication.