Long-term Effects of Inspiratory Muscle Training in Individuals With Chronic Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maximal inspiratory pressure (MIP)
研究概览
简要总结
The long-term effectiveness of inspiratory muscle training, which is known in the literature to help venous return by increasing the pump effect of the diaphragm muscle, remains unclear in individuals with chronic venous insufficiency. For this reason, in this study, it was aimed to investigate the long-term results of inspiratory muscle training in individuals with chronic venous insufficiency.
详细描述
Initial treatment of chronic venous insufficiency (CVI) includes conservative methods such as reducing symptoms and helping to prevent secondary problems and disease progression. If conservative methods fail, further treatments based on anatomical and physiological pathophysiological features should be applied. Treatment of CVI ranges from simple compression stockings to very complicated venous reconstructions. Physiotherapy applications also have an important place in the treatment of CVI and contain patient education, complex decongestive physiotherapy, intermittent pneumatic compression, compression garment, venous exercise programs, biomechanical stimulation therapy, proprioceptive neuromuscular facilitation, relaxation techniques and hydrotherapy methods.
Researches investigating the effectiveness of new physiotherapy applications in CVI are very limited. In one of these publications, the effects of inspiratory muscle training (IMT) and calf muscle exercise training (CMET) applied in addition to compression therapy (CT) on quality of life (QoL), venous filling time, disease severity, pain, edema, range of motion, muscle strength and functionality were investigated newly. IMT and CT were applied in group 1, CMET and CT were applied in group 2, and only CT was applied in group 3. As a result, groups of 1 and 2 showed more improvement in these outcomes compared to other groups. Acute effects of inspiratory muscle training in CVI was only shown in this study. The long-term effectiveness of inspiratory muscle training is still unclear in individuals with CVI. Therefore, this study aimed to investigate the long-term results of inspiratory muscle training in individuals with CVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Single-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Volunteering to participate in the study
- •Diagnosed with chronic venous insufficiency using duplex ultrasound and being under standard medical treatment follow-up
- •Being in one of the C1, C2, C3, C4 or C5 stages according to the Clinical, Etiology, Anatomy and Pathophysiology (CEAP) classification
排除标准
- •Acute deep vein thrombosis, active ulcers, psychiatric disorder requiring prior vessel ablation and/or prescription drug therapy,
- •Any history of chronic disease or deep vein thrombosis that may interfere with exercise capacity measurement,
- •Having SARS-CoV-2 (COVID-19) or any acute infection,
- •Being pregnant,
- •History of arterial disease,
- •Having advanced cardiorespiratory diseases, acute ulcer (< 3 months) and diabetic ulcers.
结局指标
主要结局
Maximal inspiratory pressure (MIP)
时间窗: After 6-week training and 3 months after 6-week training ends.
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
次要结局
- Forced vital capacity (FVC)(After 6-week training and 3 months after 6-week training ends.)
- Forced expiratory volume in the first second (FEV1)(After 6-week training and 3 months after 6-week training ends.)
- Pain Intensity measured with the Numerical Rating Scale.(After 6-week training and 3 months after 6-week training ends.)
- Aerobic capacity(After 6-week training and 3 months after 6-week training ends.)
- FEV1 / FVC(After 6-week training and 3 months after 6-week training ends.)
- Maximal expiratory pressure (MEP)(After 6-week training and 3 months after 6-week training ends.)
- Flow rate 25-75% of forced expiratory volume (FEF 25-75%)(After 6-week training and 3 months after 6-week training ends.)
- Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire(After 6-week training and 3 months after 6-week training ends.)
- Lower extremity strength(After 6-week training and 3 months after 6-week training ends.)
- Peak flow rate (PEF)(After 6-week training and 3 months after 6-week training ends.)
研究者
Gulsah Bargi
Assoc. prof
Izmir Democracy University