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Inspiratory Muscle Training Versus Calf Muscle on Venous Function

Primary Purpose

Venous Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise therapy
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring venous insufficiency, exercise therapy, inspiratory muscle, kalf muscle, venous return

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Istanbul University CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

İnspiratory muscle training group

Calf muscle training group

Control

Arm Description

Outcomes

Primary Outcome Measures

The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
Quality of life
Photoplethysmograph (PPG)
venous return time

Secondary Outcome Measures

Hand held dynamometer
muscle strength
Venous Clinical Severity Score (VCSS)
clinical severity
6 minutes walk test
functional capacity
digital goniometer
range of motion of ankle
visual analog scale
pain

Full Information

First Posted
December 25, 2019
Last Updated
May 14, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04215133
Brief Title
Inspiratory Muscle Training Versus Calf Muscle on Venous Function
Official Title
Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
venous insufficiency, exercise therapy, inspiratory muscle, kalf muscle, venous return

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
İnspiratory muscle training group
Arm Type
Experimental
Arm Title
Calf muscle training group
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
exercise therapy
Intervention Description
inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time.
Primary Outcome Measure Information:
Title
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
Description
Quality of life
Time Frame
12 months
Title
Photoplethysmograph (PPG)
Description
venous return time
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hand held dynamometer
Description
muscle strength
Time Frame
12 months
Title
Venous Clinical Severity Score (VCSS)
Description
clinical severity
Time Frame
12 months
Title
6 minutes walk test
Description
functional capacity
Time Frame
12 months
Title
digital goniometer
Description
range of motion of ankle
Time Frame
12 months
Title
visual analog scale
Description
pain
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GAMZE AYDIN, MSc
Phone
+905377600256
Email
gmzetsn@gmail.com
Facility Information:
Facility Name
Istanbul University Cerrahpasa
City
İstanbul
ZIP/Postal Code
34959
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GAMZE AYDIN
Phone
05377600256
Email
gmzetsn@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35710091
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.
Results Reference
derived

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Inspiratory Muscle Training Versus Calf Muscle on Venous Function

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