An interventional study of Training group: Inspiratory muscle training and Control group: Thoracic expansion exercise in Chronic Venous Insufficiency, sponsored by Izmir Democracy University. Terminated at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Izmir Democracy University · Not applicable, Interventional, and Supportive care
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.
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.
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →Izmir Democracy University is the lead sponsor of 73 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
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.
Other: Training group: Inspiratory muscle training
Individuals in the control group will be performed thoracic expansion exercises.
Other: Control group: Thoracic expansion exercise
The individuals in the training group will be performed inspiratory muscle training at 30-50% of the maximal inspiratory pressure. Inspiratory muscle training will be done using an inspiratory muscle training device (PowerBreathe®) that works with the threshold loading principle. Inspiratory muscle training will be done for 15 minutes per a session, 2 times per a day or, if tolerated, 30 minutes per a day and 1 time per a day, 5-7 days/week (one session under the supervision and the others at home), for a total of 6 weeks. Applications made at home will be followed with a diary.
Also known as: Experimental: Training group
Individuals in the control group will be performed thoracic expansion exercises. Thoracic expansion exercises will be applied to individuals in an upright sitting position. In this position, individuals will place their hands on their lower ribs and then perform the cycle of "deep breathing + holding the deep breath for 3 seconds + slowly emptying all the breath" 3 times in a row. After this cycle, individuals will be asked to rest by taking 3-4 calm breaths. Immediately after, the individual will be asked to repeat the same cycle and repeat the cycle with calm breaths and rest until it reaches 10 repetitions. The individual will do this session 4 times a day. Individuals will do the first session of breathing exercises under supervision. In this way, incorrect exercise will be prevented. Other breathing exercise sessions will be done by individuals as a home program every day and 4 sessions a day during 6 weeks.
Also known as: Sham Comparator: Control group
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.
Time frame: After 6-week training and 3 months after 6-week training ends.
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.
Time frame: After 6-week training and 3 months after 6-week training ends.
Forced vital capacity (FVC)
Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.
Time frame: After 6-week training and 3 months after 6-week training ends.
Forced expiratory volume in the first second (FEV1)
Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
Time frame: After 6-week training and 3 months after 6-week training ends.
FEV1 / FVC
Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Time frame: After 6-week training and 3 months after 6-week training ends.
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.
Time frame: After 6-week training and 3 months after 6-week training ends.
Peak flow rate (PEF)
Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Time frame: After 6-week training and 3 months after 6-week training ends.
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).
Time frame: After 6-week training and 3 months after 6-week training ends.
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.
Time frame: After 6-week training and 3 months after 6-week training ends.
Lower extremity strength
To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.
Time frame: 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
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.
Time frame: After 6-week training and 3 months after 6-week training ends.
Plan to share: No
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Izmir Democracy University