Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency. a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Edema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of CVI
- •aged between 18 and 85 years and
- •with mobile or email address to send the study information and follow-up
排除标准
- •Mental or psychological condition that impairs the study development
- •comorbidities that impair the physical activity performance
- •surgical interventions during the 6 previous months before the intervention or during the study development
- •deep vein thrombosis
- •active leg ulcer
结局指标
主要结局
Edema
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- CVI symptoms and severity(Baseline)
- Satisfaction with the treatment(After 16 weeks of intervention)
- Adherence to treatment(After 16 weeks of intervention)
研究者
Rodrigo Martín-San-Agustin
Doctor
University of Valencia