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Inspiratory Muscle Training Versus Calf Muscle on Venous Function

I

Istanbul University - Cerrahpasa (IUC)

Status

Unknown

Conditions

Venous Insufficiency

Treatments

Other: exercise therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04215133
IstanbulUCe

Details and patient eligibility

About

The aim of this study was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Fourty-two volunteer patients with venous insufficiency will include in the study were randomly divided into three groups as inspiratory exercise, calf muscle exercise and control. While the control group will receive only compression therapy, the inspiratory exercise group will apply inspiratory muscle training consisted of strengthening exercise in addition to compression therapy; kalf muscle exercise group will apply strengthening exercise for calf muscle in addition to compression therapy for 2 days/week with physiotherapist and 3 days/week by themselves, 8 weeks. All the patients will assess with Chronic Venous Disease Quality of life Questionnaire-20 (CIVIQ-20), Nottingham Health Profile, Photopletismograph, Venous Clinical Severity Score (VCSS), hand-held dynamometer, Visual Analogue Scale (VAS), circumference measurements, 6-minute walk test (6MWT), before and after the treatment.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Diagnosis of venous insufficiency between 18-75 years with duplex ultrasound imaging
  • CEAP classification used in venous insufficiency is C2-C3-C4-C5
  • Having written and verbal communication in Turkish

Exclusion criteria

  • Acute deep vein thrombosis
  • The presence of ulceration
  • Being in class III and IV according to the New York Heart Association classification
  • Presence of respiratory failure
  • Undergoing chemotherapy due to the presence of any cancer
  • Being in the process of treatment for neurological, orthopedic or rheumatologic diseases including lower extremity

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 3 patient groups

İnspiratory muscle training group
Experimental group
Treatment:
Other: exercise therapy
Calf muscle training group
Experimental group
Treatment:
Other: exercise therapy
Control
No Intervention group

Trial contacts and locations

1

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Central trial contact

GAMZE AYDIN, MSc

Data sourced from clinicaltrials.gov

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