Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency

Izmir Democracy University

Status: Enrolling

Conditions: Chronic Venous Insufficiency

Treatments: Other: Training group: Inspiratory muscle training; Other: Control group: Thoracic expansion exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05982405

Long effects of IMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Training group

Experimental group

Description:

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.

Treatment:

Other: Training group: Inspiratory muscle training

Control group

Sham Comparator group

Description:

Individuals in the control group will be performed thoracic expansion exercises.

Treatment:

Other: Control group: Thoracic expansion exercise