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

NCT ID: NCT05982405

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-12-30

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.

Conditions

Chronic Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Training group

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.

Group Type: EXPERIMENTAL

Training group: Inspiratory muscle training

Intervention Type: 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.

Control group

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

Group Type: SHAM_COMPARATOR

Control group: Thoracic expansion exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Experimental: Training group; Sham Comparator: Control group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Democracy University

OTHER

Sponsor Role: lead

Responsible Party

Gulsah Bargi

Assoc. prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GÜLŞAH BARĞI, Assoc. Dr.

Role: STUDY_DIRECTOR

Izmir Democracy University

ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

CEMRE GÖRÜNMEZOĞLU, MSc

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

DÜNDAR ÖZALP KARABAY, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Izmir Democracy University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 35710091 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16387263 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15883226 (View on PubMed)

Other Identifiers

Long effects of IMT

Identifier Type: -

Identifier Source: org_study_id