Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency.

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency, CVI

• Registration Number: NCT06727968
• Lead Sponsor: University of Valencia

Brief Summary

The purpose of this study is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management.

Detailed Description

This study aimed at comparing the effects of conventional therapy approaches based on compression stocking and prevention measures with a combined program of these techniques added to therapeutic exercise and self-massage explained by a physiotherapist on on functionality, general physical activity and oedema of people with CVI. In this sense, a randomized controlled trial two armed group was designed.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Diagnosed of CVI
2. aged between 18 and 85 years and
3. with mobile or email address to send the study information and follow-up

Exclusion Criteria

1. Mental or psychological condition that impairs the study development
2. comorbidities that impair the physical activity performance
3. surgical interventions during the 6 previous months before the intervention or during the study development
4. deep vein thrombosis
5. active leg ulcer
6. pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Edema	Pre-intervention and after 16 weeks of intervention	Was measured through the right and left leg circumference measurement. Four points were marked in both patients' legs (12 cm from the Hallux extreme direction to the heel, 10, 20 and 30 cm from the heel direction to knee) and total volume was calculated using the formula of the sum of all partial volumes squared divided by pi.
Functionality in gait	Pre-intervention and after 16 weeks of intervention	Was assessed using the 6-Minutes Walking Test (6MWT) that evaluates the maximum distance that the patient is able to walk in 6 minutes. To perform the test, a corridor of 30 meters with a wide enough for patients who need walking aids and at least 30 meters long is required. The place where the 30-meter distance begins and ends will be marked on the floor. Two cones will also be placed, which the patient will walk around.
Physical Activity Level	Pre-intervention and after 16 weeks of intervention	Was measured using the International Physical Activity Questionnaire (IPAQ) that is an indirect outcome measure that seeks information on the frequency and duration of walking and daily activities that require moderate to vigorous physical effort, as well as time spent sitting during the week and at the weekend.
Prevention measures employed	Pre-intervention and after 16 weeks of intervention	The prevention measures employed were quantified in a check list of 10 items that included: (1) Use of tight clothing; (2) Use of high-heeled shoes; (3) Lubrication of legs and ankles with self-massage; (4) Avoid direct heat sources on the legs; (5) Hydromassage with cold water; (6) Use of compression stockings; (7) Prevention of chronic constipation; (8) Continued trauma to legs and feet; (9) Elevate legs during the day or night; (10) Avoid long periods of sitting or standing. A total score of 0 implies that none of the venous hygiene measures was carried out, and a score of 10 implies that all of them are fulfilled.
Functionality of lower limbs	Pre-intervention and after 16 weeks of intervention	The 5 Times Sit to Stand Test (5TSTST) assesses about the functional strength of lower limbs, transitional movements, balance and risk of falling. The test is based on the amount of time it takes a patient to go from a sitting to a standing position 5 times with the arms crossed over the chest. The equipment needed to perform the test is a stopwatch and a chair of standard height.

Secondary Outcome Measures

Name	Time	Method
CVI symptoms and severity	Baseline	Venous symptoms (fatigue, cramps, heaviness, pain, irritation or tingling), previous venous symptoms, prior thrombosis and venotonic drugs intake. The severity of the CVI was measured too through the Venous Clinical Severity Score (VCSS). VCSS measures 10 clinical descriptors: pain, varicose veins, venous oedema, skin pigmentation, inflammation, induration, number of ulcers, duration of active ulcers, ulcer size and use of compression therapy. The items were scored from 0 to 3, with a total score of 30 points. This study has demonstrated good intra and interobserver reliability and has been widely used in research.
Satisfaction with the treatment	After 16 weeks of intervention	Was registered through a 10-points scored line where 0 points was the worst punctuation in satisfaction and 10 the best.
Adherence to treatment	After 16 weeks of intervention	CG and EG participants received a diary where they had to take note about when they performed the prescribed interventions (compression shocks, exercise program or massage). A compliment of the 75-100% of the total treatments has considered a very high adherence, between the 50-75% high adherence, between 25-50% low and less than 25% very low.

Trial Locations

Locations (1)

Spain; 🇪🇸 Valencia, Spain