Chronic Venous Insufficiency Clinical Trial
Official title:
Long-term Effects of Inspiratory Muscle Training in Individuals With Chronic Venous Insufficiency
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Democracy University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Izmir Democracy University |
Turkey,
Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14. — View Citation
Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available. — View Citation
Weiss RA, Munavalli G. Endovenous ablation of truncal veins. Semin Cutan Med Surg. 2005 Dec;24(4):193-9. doi: 10.1016/j.sder.2005.10.006. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal inspiratory pressure (MIP) | 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. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Maximal expiratory pressure (MEP) | 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. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Forced vital capacity (FVC) | Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Forced expiratory volume in the first second (FEV1) | Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | FEV1 / FVC | Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Flow rate 25-75% of forced expiratory volume (FEF 25-75%) | Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) will be evaluated with a spirometer. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Peak flow rate (PEF) | Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Pain Intensity measured with the Numerical Rating Scale. | Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain). | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Aerobic capacity | 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. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Lower extremity strength | To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair. | After 6-week training and 3 months after 6-week training ends. | |
Secondary | Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire | The score will be evaluated using Chronic Venous Disease Quality of Life Questionnaire. Each question is scored on a 5-item Likert scale. Higher scores indicate better quality of life. | After 6-week training and 3 months after 6-week training ends. |
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