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

Primary Purpose

Chronic Venous Insufficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Training group: Inspiratory muscle training
Control group: Thoracic expansion exercise
Sponsored by
Izmir Democracy University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Venous Insufficiency focused on measuring Venous Insufficiency, pain, edema, respiratory function tests, maximal respiratory pressures, exercise capacity, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Izmir Democracy University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Training group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Maximal inspiratory pressure (MIP)
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.

Secondary Outcome Measures

Maximal expiratory pressure (MEP)
The MEP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Forced vital capacity (FVC)
Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.
Forced expiratory volume in the first second (FEV1)
Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
FEV1 / FVC
Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) will be evaluated with a spirometer.
Peak flow rate (PEF)
Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Pain Intensity measured with the Numerical Rating Scale.
Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain).
Aerobic capacity
The six-minute walk test (6-MWT) will be performed according to the criteria of the American Thoracic Society for the evaluation of aerobic capacity.
Lower extremity strength
To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
The score will be evaluated using Chronic Venous Disease Quality of Life Questionnaire. Each question is scored on a 5-item Likert scale. Higher scores indicate better quality of life.

Full Information

First Posted
July 28, 2023
Last Updated
September 13, 2023
Sponsor
Izmir Democracy University
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1. Study Identification

Unique Protocol Identification Number
NCT05982405
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Democracy University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
Venous Insufficiency, pain, edema, respiratory function tests, maximal respiratory pressures, exercise capacity, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Individuals in the control group will be performed thoracic expansion exercises.
Intervention Type
Other
Intervention Name(s)
Training group: Inspiratory muscle training
Other Intervention Name(s)
Experimental: Training group
Intervention Description
The individuals in the training group will be performed inspiratory muscle training at 30-50% of the maximal inspiratory pressure. Inspiratory muscle training will be done using an inspiratory muscle training device (PowerBreathe®) that works with the threshold loading principle. Inspiratory muscle training will be done for 15 minutes per a session, 2 times per a day or, if tolerated, 30 minutes per a day and 1 time per a day, 5-7 days/week (one session under the supervision and the others at home), for a total of 6 weeks. Applications made at home will be followed with a diary.
Intervention Type
Other
Intervention Name(s)
Control group: Thoracic expansion exercise
Other Intervention Name(s)
Sham Comparator: Control group
Intervention Description
Individuals in the control group will be performed thoracic expansion exercises. Thoracic expansion exercises will be applied to individuals in an upright sitting position. In this position, individuals will place their hands on their lower ribs and then perform the cycle of "deep breathing + holding the deep breath for 3 seconds + slowly emptying all the breath" 3 times in a row. After this cycle, individuals will be asked to rest by taking 3-4 calm breaths. Immediately after, the individual will be asked to repeat the same cycle and repeat the cycle with calm breaths and rest until it reaches 10 repetitions. The individual will do this session 4 times a day. Individuals will do the first session of breathing exercises under supervision. In this way, incorrect exercise will be prevented. Other breathing exercise sessions will be done by individuals as a home program every day and 4 sessions a day during 6 weeks.
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure (MIP)
Description
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Secondary Outcome Measure Information:
Title
Maximal expiratory pressure (MEP)
Description
The MEP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Forced vital capacity (FVC)
Description
Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Forced expiratory volume in the first second (FEV1)
Description
Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
FEV1 / FVC
Description
Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Description
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) will be evaluated with a spirometer.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Peak flow rate (PEF)
Description
Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Pain Intensity measured with the Numerical Rating Scale.
Description
Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain).
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Aerobic capacity
Description
The six-minute walk test (6-MWT) will be performed according to the criteria of the American Thoracic Society for the evaluation of aerobic capacity.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Lower extremity strength
Description
To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.
Time Frame
After 6-week training and 3 months after 6-week training ends.
Title
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
Description
The score will be evaluated using Chronic Venous Disease Quality of Life Questionnaire. Each question is scored on a 5-item Likert scale. Higher scores indicate better quality of life.
Time Frame
After 6-week training and 3 months after 6-week training ends.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GÜLŞAH BARĞI, Assoc. Dr.
Phone
+90 232 299 0739
Email
gulsahbargi35@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.
Phone
0232 299 0733
Email
ozlem.cinar@idu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GÜLŞAH BARĞI, Assoc. Dr.
Organizational Affiliation
Izmir Democracy University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.
Organizational Affiliation
Izmir Democracy University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CEMRE GÖRÜNMEZOĞLU, MSc
Organizational Affiliation
Izmir Democracy University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DÜNDAR ÖZALP KARABAY, Prof. Dr.
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Democracy University
City
İzmir
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GÜLŞAH BARĞI, Assoc. Dr.
Phone
0232 299 0739
Email
gulsahbargi35@gmail.com
First Name & Middle Initial & Last Name & Degree
ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.
Phone
0232 299 0733
Email
ozlem.cinar@idu.edu.tr

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
background
PubMed Identifier
16387263
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.
Results Reference
background
PubMed Identifier
15883226
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.
Results Reference
background

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

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