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Not Yet Recruiting NCT07907978

Phenotyping Rehabilitation for Improving Frailty, Functional Capacity

Conditions: Varicose Veins

Sex: All
Ages: 60 Years – 95 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Beni-Suef University

Summary

Chronic venous insufficiency (CVI) is associated with reduced mobility, frailty, impaired physical performance, and decreased quality of life in older adults. Traditional rehabilitation programs primarily focus on calf muscle function and venous symptom management, but often fail to address the heterogeneity of functional impairments observed in this population. This randomized controlled trial aims to investigate whether a performance-based phenotyping approach for individualized rehabilitation is more effective than a standardized multicomponent rehabilitation program in improving physical performance, frailty, functional capacity, and venous outcomes in older adults with CVI. Participants will be randomly assigned to either a phenotype-guided individualized rehabilitation program or a standardized rehabilitation program for 12 weeks, with outcomes assessed at baseline, post-intervention, and 24-week follow-up. The primary outcome is physical performance measured by the Short Physical Performance Battery (SPPB). Secondary outcomes include frailty status, mobility, sarcopenia indicators, functional capacity, venous symptoms, and quality of life.

Eligibility Criteria

Inclusion Criteria: * Age 60 years or older. * Physician-confirmed diagnosis of chronic venous insufficiency (CVI). * CEAP classification C2 to C5 * Community-dwelling older adults. * Medically stable. * Able to ambulate independently, with or without an assistive device. * SARC-F score ≥ 4, indicating elevated risk of sarcopenia or functional impairment. Exclusion Criteria: * Active venous ulcers requiring intensive wound management. * Lower-limb surgery within the previous 6 months. * Severe peripheral arterial disease (ABI \< 0.5). * Severe cardiopulmonary conditions that limit exercise participation. * Neurological disorders affecting mobility. * Severe cognitive impairment (MMSE \< 18). * Uncontrolled hypertension. * Recent deep venous thrombosis (DVT) within the previous 3 months. * Musculoskeletal disorders that interfere with rehabilitation or outcome assessment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07907978). StuddyBuddy aggregates publicly available trial information.