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

NCT05982405 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-18

No results posted yet for this study

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

Interventions

OTHER

Training group: Inspiratory muscle training

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.

OTHER

Control group: Thoracic expansion exercise

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.

Sponsors & Collaborators

  • Izmir Democracy University

    lead OTHER

Principal Investigators

  • GÜLŞAH BARĞI, Assoc. Dr. · Izmir Democracy University

  • ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr. · Izmir Democracy University

  • CEMRE GÖRÜNMEZOĞLU, MSc · Izmir Democracy University

  • DÜNDAR ÖZALP KARABAY, Prof. Dr. · Dokuz Eylul University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-06-30
Completion
2024-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05982405 on ClinicalTrials.gov