Clinical trial NCT05993650: Inspiratory Muscle Training in Chronic Venous Diseases
Official title: Inspiratory Muscle Training in Individuals With Chronic Venous Disease : A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency
Keywords: chronic venous insufficiency
maximal respiratory pressures
respiratory function tests
exercise capacity
edema
pain
quality of life
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessment
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with CVI
* Being between C1-C5 according to the 'Clinical, Etiologic, Anatomic, Pathophysiologic' (CEAP) scale,
* To accept to participate in the study,

Exclusion Criteria:

* Arterial diseases,
* Presence of advanced cardiorespiratory diseases,
* Having orthopedic and neurological disorders that may affect walking,
* Presence of acute ulcer (\< 3 months) and diabetic ulcers,
* Being pregnant.
* Having a history of deep vein thrombosis,
* Having undergone venous system surgery

Primary outcomes:
measure: Maximal inspiratory pressure (MIP)
timeFrame: After 6-week training
Secondary outcomes:
measure: Maximal expiratory pressure (MEP)
timeFrame: After 6-week training
measure: Forced vital capacity (FVC)
timeFrame: After 6-week training.
measure: Forced expiratory volume in the first second (FEV1)
timeFrame: After 6-week training.
measure: FEV1 / FVC
timeFrame: After 6-week training.
measure: Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
timeFrame: After 6-week training.
measure: Peak flow rate (PEF)
timeFrame: After 6-week training.
measure: Aerobic capacity assessment
timeFrame: After 6-week training.
measure: Lower extremity strength
timeFrame: After 6-week training.
measure: Edema assessment
timeFrame: After 6-week training.
measure: Quality of life assessment
timeFrame: After 6-week training.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
state: Karabağlar/İZMİR
Study officials:
affiliation: Izmir Democracy University
name: Özlem Çinar Özdemir
role: STUDY_DIRECTOR
affiliation: Izmir Democracy University
name: Gülşah BARĞI
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Democracy University
name: Cemre GÖRÜNMEZOĞLU, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Dündar Özalp KARABAY
role: PRINCIPAL_INVESTIGATOR
References:
citation: OZDEMIR, Özlem Çınar; BAKAR, Yeşim; SÜRMELI, Mahmut. Kronik Venöz Yetmezlikte Ağrı, Yaşam Kalitesi Ve Depresyon Arasındaki İlişkinin İncelenmesi. Konuralp Medical Journal/Konuralp Tip Dergisi, 2017, 9.2.
citation: 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.
citation: Kwon OY, Jung DY, Kim Y, Cho SH, Yi CH. Effects of ankle exercise combined with deep breathing on blood flow velocity in the femoral vein. Aust J Physiother. 2003;49(4):253-8. doi: 10.1016/s0004-9514(14)60141-0.
citation: Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016 Mar 31;5:381. doi: 10.1186/s40064-016-2039-2. eCollection 2016.