Chronic Venous Insufficiency Clinical Trial
Official title:
Inspiratory Muscle Training in Individuals With Chronic Venous Disease : A Randomized Controlled Study
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02462096 -
A Feasibility Study of the ReLeaf Catheter System
|
N/A | |
Enrolling by invitation |
NCT05504070 -
Venclose digiRF System Post Market Study
|
N/A | |
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Recruiting |
NCT05622500 -
Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease
|
N/A | |
Completed |
NCT03283800 -
Copper Impact on Venous Insufficiency and Lipodermatosclerosis
|
N/A | |
Completed |
NCT01501188 -
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
|
Phase 1 | |
Terminated |
NCT02248740 -
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein
|
Phase 4 | |
Completed |
NCT02236338 -
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
|
Phase 4 | |
Recruiting |
NCT05982405 -
Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency
|
N/A | |
Completed |
NCT05383469 -
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
|
N/A | |
Completed |
NCT06238791 -
Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
|
||
Withdrawn |
NCT02559427 -
SPA Therapy in the Treatment of Sleep Apnea Syndrome
|
N/A | |
Completed |
NCT02346058 -
Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
|
Phase 4 | |
Active, not recruiting |
NCT05926830 -
Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study
|
N/A | |
Withdrawn |
NCT05047302 -
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System-Canada
|
N/A | |
Active, not recruiting |
NCT04339075 -
Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
|
||
Active, not recruiting |
NCT04580160 -
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
|
N/A | |
Not yet recruiting |
NCT02927483 -
Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency
|
Phase 3 | |
Completed |
NCT02015221 -
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
|
N/A | |
Completed |
NCT02050061 -
Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
|
N/A |