Studying the effect of inspiratory breathing exercises on the quality of life and vascular flow of patients with lower limb venous insufficiency referred to Hospital

Studying the effect of inspiratory breathing exercises on the quality of life and vascular flow of patients with lower limb venous insufficiency referred to the Hospital

The present clinical trial study has 1 control group and 1 intervention group, with parallel and double-blind groups, randomized, and a sample size of 50 patients.

This study is a clinical trial in patients with lower extremity venous insufficiency referred to Taleghani Hospital. After signing the consent form, a quality of life questionnaire and lower extremity plethysmography will be completed by a vascular surgeon and saphenous vein refill time (VRT) will be measured. In the control group, calf muscle strengthening exercises will be performed, and in the intervention group, patients will use the IMT device in addition to calf muscle strengthening exercises. The patient and the surgeon are blinded.

The inclusion criteria included the age range of 18 to 65 years, having informed consent to participate in the study, having no previous history of performing breathing exercises or other similar protocols, a definitive diagnosis of lower extremity venous insufficiency, and the exclusion criteria included the patient's unwillingness to continue participating in the study, worsening of the patient's condition or death before the end of the 2-month study period, and starting new treatment protocols for the patient that interfered with inspiratory breathing exercises.

In the control group, calf muscle strengthening exercises will be performed three sessions per week. In the intervention group, in addition to calf muscle strengthening exercises, inspiratory breathing exercises will be performed using the inspiratory muscle training (IMT) device.

Quality of lie, Venous refilling time

Simple randomization method, individual randomization unit, randomization tool: random number table, double blind. For randomization, the Simple Randomization method is used using a random number table. For this purpose, two groups (A, B) are considered. We choose one of the rows of the random number table at will and we know that the numbers in each row will be between 0 and 9. Then we assign the numbers 0-4 to treatment A and the numbers 5-9 to treatment B. Suppose the numbers for the first row are as follows: 0, 5, 2, 7, 8, 4. Therefore, the number 0 is assigned to treatment A, the number 5 to treatment B, the number 2 to treatment A, .... Therefore, the first person receives treatment A, the second person receives treatment B ....

Patients are not aware that the IMT device is the main component of the intervention. Both groups have exercises, so no obvious sense of difference is created. Also, the vascular surgeon is blinded to the group allocation.