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

NCT05982405 | Terminated

• 1 other identifier: Long effects of IMT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency

Keywords

Venous Insufficiency; pain; edema; respiratory function tests; maximal respiratory pressures; exercise capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  After 6-week training and 3 months after 6-week training ends.

Secondary Outcomes (10)

• Maximal expiratory pressure (MEP)

  After 6-week training and 3 months after 6-week training ends.

• Forced vital capacity (FVC)

  After 6-week training and 3 months after 6-week training ends.

• Forced expiratory volume in the first second (FEV1)

  After 6-week training and 3 months after 6-week training ends.

• FEV1 / FVC

  After 6-week training and 3 months after 6-week training ends.

• Flow rate 25-75% of forced expiratory volume (FEF 25-75%)

  After 6-week training and 3 months after 6-week training ends.

Study Arms (2)

Training group

EXPERIMENTAL

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.

Other: Training group: Inspiratory muscle training

Control group

SHAM COMPARATOR

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

Other: Control group: Thoracic expansion exercise

Interventions

Training group: Inspiratory muscle training OTHER

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.

Also known as: Experimental: Training group

Training group

Control group: Thoracic expansion exercise OTHER

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.

Also known as: Sham Comparator: Control group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35710091 BACKGROUND

• 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.

  PMID: 16387263 BACKGROUND

• 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.

  PMID: 15883226 BACKGROUND

MeSH Terms

Conditions

Venous Insufficiency; Pain; Edema

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GÜLŞAH BARĞI, Assoc. Dr.

  Izmir Democracy University

  STUDY DIRECTOR

• ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• CEMRE GÖRÜNMEZOĞLU, MSc

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• DÜNDAR ÖZALP KARABAY, Prof. Dr.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 8, 2023
• Study Start: September 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)