Inspiratory Muscle Training in Chronic Venous Diseases

NCT05993650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-17

No results posted yet for this study

Summary

There is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.

Conditions

  • Chronic Venous Insufficiency

Interventions

OTHER

Inspiratuar Muscle Training Group

Inspiratory muscle training will be done for 15 minutes/session, 2 times/day, or 30 minutes/day if tolerated, 5-7 days/week (one under supervision and others at home), for a total of 6 weeks. Applications made at home will be followed with a diary. Inspiratory muscle training will be performed using an inspiratory muscle training device (PowerBreathe®) working with the threshold loading principle.In the first week of the training, 30-50% of the maximal inspiratory pressure (MIP) measured in the initial evaluation of the individual will be adjusted according to the patient's tolerance, and inspiratory muscle training will be performed. Respiratory muscle strength measurement will be repeated every week in the individuals in the training group. 30-50% of the new MIP value obtained will be calculated and adjusted by calculating the new training workload for the application of inspiratory muscle training in the following weeks

OTHER

Thoracic Expansion Exercise Group

Individuals in this group will be given thoracic expansion exercises and patient education. 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 "inhale a deep breathing + holding the deep breath for 3 seconds + slowly exhale 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

  • Özlem Çinar Özdemir · Izmir Democracy University

  • Gülşah BARĞI · Izmir Democracy University

  • Cemre GÖRÜNMEZOĞLU, MSc · Izmir Democracy University

  • Dündar Özalp KARABAY · 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
2023-07-20
Primary Completion
2024-07-10
Completion
2024-07-24

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 NCT05993650 on ClinicalTrials.gov