Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency
- Conditions
- Chronic Venous Insufficiency
- Registration Number
- NCT05982405
- Lead Sponsor
- Izmir Democracy University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maximal inspiratory pressure (MIP) 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.
- Secondary Outcome Measures
Name Time Method Forced vital capacity (FVC) After 6-week training and 3 months after 6-week training ends. Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.
Forced expiratory volume in the first second (FEV1) After 6-week training and 3 months after 6-week training ends. Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
Pain Intensity measured with the Numerical Rating Scale. After 6-week training and 3 months after 6-week training ends. 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).
Aerobic capacity After 6-week training and 3 months after 6-week training ends. 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.
FEV1 / FVC After 6-week training and 3 months after 6-week training ends. Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Maximal expiratory pressure (MEP) After 6-week training and 3 months after 6-week training ends. 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.
Flow rate 25-75% of forced expiratory volume (FEF 25-75%) After 6-week training and 3 months after 6-week training ends. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) will be evaluated with a spirometer.
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. 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.
Lower extremity strength After 6-week training and 3 months after 6-week training ends. To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.
Peak flow rate (PEF) After 6-week training and 3 months after 6-week training ends. Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Trial Locations
- Locations (1)
Izmir Democracy University
🇹🇷İzmir, Turkey