An interventional study of Phenotype-Guided Individualized Rehabilitation and Standardized Multicomponent Rehabilitation in Varicose Veins, sponsored by Beni-Suef University. Not yet recruiting. Open to participants aged 60 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
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.
Chronic venous insufficiency (CVI) is a common progressive vascular disorder affecting a substantial proportion of older adults. The condition is characterized by venous hypertension resulting from venous valvular dysfunction and/or venous outflow obstruction, leading to symptoms such as leg pain, heaviness, edema, fatigue, reduced mobility, and impaired quality of life. Although exercise-based rehabilitation has demonstrated benefits for calf muscle pump function and venous circulation, the broader impact of rehabilitation on frailty, physical performance, and functional decline remains insufficiently explored.
Older adults with CVI frequently present with age-related impairments including sarcopenia, muscle weakness, balance deficits, and reduced mobility. These impairments may contribute to deterioration in calf muscle pump performance and worsening venous symptoms, while venous symptoms themselves may reduce physical activity participation, creating a cycle of functional decline and disease progression. Frailty is increasingly recognized as an important predictor of disability, falls, hospitalization, and mortality in older adults; however, it has rarely been targeted within CVI rehabilitation programs.
This study introduces a novel rehabilitation model termed Performance-Based Phenotyping for Precision Physiotherapy, in which rehabilitation interventions are individualized according to participants' dominant functional deficits identified through objective performance-based assessments. Following a standardized functional assessment battery, participants allocated to the experimental group will be categorized into predefined phenotypes reflecting strength deficits, mobility and fall-related impairments, lower-limb power limitations, or mixed functional impairments. Each phenotype will receive a rehabilitation program specifically tailored to its dominant impairment profile while maintaining common CVI-related rehabilitation components.
The study will be conducted as a prospective, assessor-blinded, parallel-group randomized controlled trial. Community-dwelling adults aged 60 years and older with physician-confirmed chronic venous insufficiency (CEAP stages C2-C5) and elevated risk of sarcopenia or functional decline (SARC-F score ≥4) will be recruited and randomly assigned in a 1:1 ratio to either individualized phenotype-based rehabilitation or standardized multicomponent rehabilitation. Both groups will participate in supervised rehabilitation sessions three times per week for 12 weeks, with each session lasting approximately 60 minutes. Participants will then be followed for an additional 12 weeks to assess the durability of treatment effects.
The primary outcome will be physical performance assessed using the Short Physical Performance Battery (SPPB). Secondary outcomes will include frailty status measured by the Fried Frailty Phenotype, mobility assessed by the Timed Up and Go Test, sarcopenia-related measures including handgrip strength and the Five Times Sit-to-Stand Test, functional capacity measured by the Six-Minute Walk Test, venous outcomes including the Venous Clinical Severity Score (VCSS), limb circumference and leg heaviness, and health-related quality of life measured using the CIVIQ-14 questionnaire. Outcomes will be assessed at baseline, post-intervention (12 weeks), and follow-up (12 weeks).
The investigators hypothesize that individualized rehabilitation guided by performance-based phenotyping will result in greater improvements in physical performance, frailty, mobility, functional capacity, venous symptoms, and quality of life compared with a standardized rehabilitation approach. This study may provide evidence supporting precision rehabilitation strategies for older adults with chronic venous insufficiency and contribute to the development of more targeted physiotherapy interventions for this growing population.
259 studies on the registry are indexed under Varicose Veins; 37 are open to participants now.
This study's planned enrollment of 60 is below the median of 103 across 166 interventional studies indexed under Varicose Veins.
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Participants undergo a baseline functional assessment battery and are assigned to one of four functional phenotypes (Strength-Dominant, Mobility/Falls-Dominant, Power/Stair-Dominant, or Mixed Impairment). Each phenotype receives a tailored rehabilitation program targeting the participant's dominant functional deficits. All participants also receive common chronic venous insufficiency rehabilitation components including calf muscle pump exercises, ankle mobility exercises, compression therapy education, home exercise training, and physical activity counseling. The intervention is delivered 3 times per week for 12 weeks.
Other: Phenotype-Guided Individualized Rehabilitation
Participants receive a standardized rehabilitation program consisting of calf strengthening exercises, ankle mobility exercises, walking exercise, general balance training, and stretching without functional phenotyping or individualized treatment allocation. The intervention is delivered 3 times per week for 12 weeks
Other: Standardized Multicomponent Rehabilitation
A 12-week supervised rehabilitation program delivered three times weekly. Participants undergo performance-based phenotyping and are assigned to a tailored exercise program targeting their dominant functional impairment (strength deficit, mobility/fall-risk impairment, power limitation, or mixed impairment). The intervention includes individualized progressive resistance training, balance and gait training, power-focused exercises, functional mobility training, calf muscle pump exercises, ankle mobility exercises, physical activity counseling, and a home exercise program.
Also known as: rehabilitation exercises
A 12-week supervised rehabilitation program delivered three times weekly. Participants receive a standardized exercise protocol consisting of calf strengthening exercises, lower-limb resistance exercises, walking training, balance exercises, flexibility exercises, ankle mobility training, physical activity counseling, and a home exercise program. The intervention is not individualized according to participant phenotype or functional performance profile.
Also known as: rehabilitation exercises
Short Physical Performance Battery (SPPB)
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which evaluates balance, gait speed, and lower-extremity strength. Scores range from 0 to 12, with higher scores indicating better physical performance
Time frame: Baseline, Week 12 (end of intervention), and Week 24 (12-week follow-up).
Fried Frailty Phenotype
Frailty status will be assessed using the Fried Frailty Phenotype, including weight loss, exhaustion, weakness, slow gait speed, and low physical activity. Higher frailty category indicates worse frailty status.
Time frame: Baseline, Week 12 (end of intervention), and Week 24 (12-week follow-up).
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