Clinical trial NCT05982405: Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency
Official title: Long-term Effects of Inspiratory Muscle Training in Individuals With Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Venous Insufficiency
Keywords: Venous Insufficiency
pain
edema
respiratory function tests
maximal respiratory pressures
exercise capacity
quality of life
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximal inspiratory pressure (MIP)
timeFrame: After 6-week training and 3 months after 6-week training ends.
Secondary outcomes:
measure: Maximal expiratory pressure (MEP)
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Forced vital capacity (FVC)
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Forced expiratory volume in the first second (FEV1)
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: FEV1 / FVC
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Peak flow rate (PEF)
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Pain Intensity measured with the Numerical Rating Scale.
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Aerobic capacity
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Lower extremity strength
timeFrame: After 6-week training and 3 months after 6-week training ends.
measure: Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
timeFrame: After 6-week training and 3 months after 6-week training ends.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: GÜLŞAH BARĞI, Assoc. Dr.
role: STUDY_DIRECTOR
affiliation: Izmir Democracy University
name: ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Democracy University
name: CEMRE GÖRÜNMEZOĞLU, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: DÜNDAR ÖZALP KARABAY, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.
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.