Inspiratory Muscle Training in Chronic Venous Diseases
- Conditions
- Chronic Venous Insufficiency
- Interventions
- Other: Inspiratuar Muscle Training GroupOther: Thoracic Expansion Exercise Group
- Registration Number
- NCT05993650
- Lead Sponsor
- Izmir Democracy University
- Brief Summary
There is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.
- Detailed Description
Chronic venous insufficiency (CVI) is defined as a very common condition that affects the venous system in the lower extremities, including various pathologies and subjective symptoms such as pain, cramps, restlessness in the legs, edema, itching and skin changes. CVI is a disease that develops due to venous hypertension in the lower extremities, resulting in impaired turbulent flow fields, venous distention, free radical formation and inflammation. In addition to being a cosmetic problem, symptoms such as pain, itching, burning, tingling, night cramps, edema, skin changes and venous ulcers in chronic cases can be seen. It is seen between 5-30% in the adult population. CVI affects 40% of the general population. Because of its high prevalence, chronic venous diseases are a common condition that causes major socioeconomic impacts. According to the studies; it has been observed that 32% of women and 40% of men have varicose veins, and any type of venous disease affects 40-50% of men and 50-55% of.
The main clinical features of CVI are dilated veins, edema, leg pain, muscle cramps, and cutaneous changes in the leg. Edema begins in the perimalleolar region and ascendes up the leg. Leg restlessness is often described as heaviness or pain after prolonged standing and is relieved by leg elevation. This discomfort is caused by increased intracompartmental and subcutaneous volume and pressure. Venous valves and venous pump are the two major determinants of venous flow. Venous valves play a role in directing the flow from the superficial system to the deep system and in its progression from the proximal veins to the distal veins.
Venous function is reflected in venous return, venous resistance, and its effects on cardiac output. Venous filling time is a parameter of venous function and is shortened as a result of valve insufficiency, vessel wall enlargement and inability of muscle pumps to work actively. The calf muscles compress the deep intramuscular veins, diverting blood flow from the veins to the heart. This mechanism depends on talocrural mobility and the force of contraction of the calf muscles. However, muscle pump dysfunction is not limited to the calf, but also includes inspiratory muscle dysfunction, such as when the diaphragm allows greater blood flow to the heart from the lower extremities, creating a suction effect on the inferior vena cava during inspiration and expiration. It has been shown that the respiratory cycle affects the increase of deep inspiration and the flow rate of the femoral vein and venous return in healthy individuals. When inspiratory muscle strength is insufficient, blood flow in the leg veins will decrease, increasing vascular resistance and thus systemic refill can be reduced. Increasing the muscle strength of inspiration with inspiratory muscle training is considered to increase venous return and improve symptoms of CVI, including pain and edema. However, there is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Being diagnosed with CVI
- Being between C1-C5 according to the 'Clinical, Etiologic, Anatomic, Pathophysiologic' (CEAP) scale,
- To accept to participate in the study,
- Arterial diseases,
- Presence of advanced cardiorespiratory diseases,
- Having orthopedic and neurological disorders that may affect walking,
- Presence of acute ulcer (< 3 months) and diabetic ulcers,
- Being pregnant.
- Having a history of deep vein thrombosis,
- Having undergone venous system surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training Group Inspiratuar Muscle Training Group The individuals in the training group will be performed inspiratory muscle training using an inspiratory muscle training device (PowerBreathe®) at 30-50% of the maximal inspiratory pressure. Control Group Thoracic Expansion Exercise Group Individuals in this group will be given thoracic expansion exercises and patient education.
- Primary Outcome Measures
Name Time Method Maximal inspiratory pressure (MIP) After 6-week training 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.
- Secondary Outcome Measures
Name Time Method FEV1 / FVC After 6-week training. Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Peak flow rate (PEF) After 6-week training. Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Aerobic capacity assessment After 6-week training. The six-minute walk test (6-MWT) will be performed according to the criteria of the American Thoracic Society for the evaluation of aerobic capacity.
Forced vital capacity (FVC) After 6-week training. Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer. In the study, measurements will be made using the Cosmed Omnia microQuark 1.5 (Cosmed, Rome, Italy) device. Considering that dizziness may occur during forced expiration, measurements will be made while individuals are in a sitting position. While participants are sitting in a comfortable position in a chair with a backrest, nose clip will be attached and they will be asked to bite the mouthpieces with their teeth and close their lips in a way that does not allow air to escape. The tests will be performed at least 3 times by the participants and care will be taken to ensure that the expiration time is at least 6 seconds and the plateau time is 1 second. Due to the device software that records all three data, it saves the average of the two best data and processes it as a value.
Maximal expiratory pressure (MEP) After 6-week training The MEP 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.
Forced expiratory volume in the first second (FEV1) After 6-week training. Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
Flow rate 25-75% of forced expiratory volume (FEF 25-75%) After 6-week training. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) will be evaluated with a spirometer.
Lower extremity strength After 6-week training. To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair
Edema assessment After 6-week training. It is planned to evaluate the edema in the lower extremity by measuring the circumference with a tape measure. Both legs will be recorded separately and the difference will be calculated. A bendable, non-elastic, 7 mm wide standard tape measure with an accuracy of 0.1 cm will be used for circumference measurements. The "0" (zero) end of the tape measure will be wrapped around the area to be measured, with the "0" (zero) end in the left hand and the other end in the right hand, and the number above the "0" (zero) point will be noted
Quality of life assessment After 6-week training. Quality of life will be evaluated using Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20).CIVIQ-20 is a quality of life survey that contains 20 questions and is specific for Chronic Venous Insufficiency, encompassing four quality of life domains: physical, psychological and social impairment and the severity of pain. There is a 5-point answer rating in each question, according to which higher scores indicate more severe impairment. There is a score varying from 0 to 100 in the CIVIQ-20 where the higher scores indicate better quality of life.
Trial Locations
- Locations (1)
Izmir Democracy University
🇹🇷İzmir, Karabağlar/İZMİR, Turkey