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The effects of home-based strengthening calf muscle exercise program with graduated compression stockings on disease severity, muscle and joint function and quality of life among people with chronic venous insufficiency: a randomized controlled trial

The effects of home-based strengthening calf muscle exercise program with graduated compression stockings on disease severity, muscle and joint function and quality of life among people with chronic venous insufficiency: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260307002
Enrollment
50
Registered
2026-03-07
Start date
2024-10-15
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed with chronic venous insufficiency (CVI) were classified in CEAP Class 3-5 Class 3 indicates swelling in the legs. Often found in people who sit with their legs dangling or stand for a long time, C4 means there are changes in the skin and subcutaneous layers, divided into two symptoms: C4a, the skin on the ankle is darker, may have blisters and itching, and C4b, the skin is hard and pale on the ankle, and C5 means there was a wound on the leg and it has healed.

Interventions

The experimental group received a 12-week home-based calf-strengthening exercise program in combination with medical compression stockings. Outcome measures were assessed at three time points, baseli
Intervention group,Control group

Sponsors

Ramathibodi School of Nursing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over, both male and female. 2. Patients diagnosed with chronic venous insufficiency (CVI) were classified in CEAP Class 3-5, as assessed by a physician specializing in vascular surgery, where Class 3 indicates swelling in the legs. Often found in people who sit with their legs dangling or stand for a long time, C4 means there are changes in the skin and subcutaneous layers, divided into two symptoms: C4a, the skin on the ankle is darker, may have blisters and itching, and C4b, the skin is hard and pale on the ankle, and C5 means there was a wound on the leg and it has healed. 3.A person with full consciousness can perceive the day, time, and place and can communicate by listening, speaking, reading, and writing Thai. For individuals over 60 years old who are screened with the Mini-Cog and score three or more, it indicates no cognitive impairment. 4. Consent to participate in this research voluntarily. 5. Able to use a telephone to communicate, and the patient or relative has the LINE application to communicate. 6. Not diagnosed with deep vein thrombosis in both legs based on the results of the Duplex ultrasound within the past 3 months. 7. From the initial physical examination, there is no swelling on either leg, a difference of more than 3 centimeters, red legs, tenderness, tightness, and swollen veins. Warm skin at the site of blood clot or Homan's sign positive (pain in the calf when the tip of the foot is raised)

Exclusion criteria

Exclusion criteria: 1. Severe or unstable cardiopulmonary pathology 2. Unable to stand, have problems with strength or balance, at risk of falls 3. Have thrombophlebitis or open wounds on the legs that cannot be worn with medical stockings or have severe leg swelling that cannot be worn with medical stockings

Design outcomes

Primary

MeasureTime frame
Disease severity begin (0 week), 6 week, 12 week The Revised Venous Clinical Severity Score (rVCSS) ,Disease severity begin (0 week), 6 week, 12 week swelling

Secondary

MeasureTime frame
Muscle and joint function begin (0 week), 6 week, 12 week Calf muscle strength,Muscle and joint function begin (0 week), 6 week, 12 week Ankle range of motion,Quality of life begin (0 week), 6 week, 12 week Chronic venous disease quality of life questionnaire (CIVIQ-20)

Countries

Thailand

Contacts

Public ContactKulweena Sisayanarane

Police Nursing College Instructor nursing

kulweena.sis@student.mahidol.edu0956429169

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: May 1, 2026