Inspiratory Muscle Training in Chronic Venous Diseases

NCT05993650 | Completed

• 1 other identifier: IMT in Venous Diseases
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic venous insufficiency; maximal respiratory pressures; respiratory function tests; exercise capacity; edema; pain; 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

Secondary Outcomes (10)

• Maximal expiratory pressure (MEP)

  After 6-week training

• Forced vital capacity (FVC)

  After 6-week training.

• Forced expiratory volume in the first second (FEV1)

  After 6-week training.

• FEV1 / FVC

  After 6-week training.

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

  After 6-week training.

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: Inspiratuar Muscle Training Group

Control Group

SHAM COMPARATOR

Individuals in this group will be given thoracic expansion exercises and patient education.

Other: Thoracic Expansion Exercise Group

Interventions

Inspiratuar Muscle Training Group OTHER

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

Also known as: Inspiratuar Muscle Training

Training Group

Thoracic Expansion Exercise Group OTHER

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.

Control Group

Eligibility Criteria

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

You may qualify if:

• Being diagnosed with CVI
• Being between C1-C5 according to the 'Clinical, Etiologic, Anatomic, Pathophysiologic' (CEAP) scale,
• To accept to participate in the study,

You may not qualify if:

• Arterial diseases,
• Presence of advanced cardiorespiratory diseases,
• Having orthopedic and neurological disorders that may affect walking,
• Presence of acute ulcer (\< 3 months) and diabetic ulcers,
• Being pregnant.
• Having a history of deep vein thrombosis,
• Having undergone venous system surgery

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, Karabağlar/İZMİR, 35140, Turkey (Türkiye)

Location

Related Publications (4)

• OZDEMIR, Özlem Çınar; BAKAR, Yeşim; SÜRMELI, Mahmut. Kronik Venöz Yetmezlikte Ağrı, Yaşam Kalitesi Ve Depresyon Arasındaki İlişkinin İncelenmesi. Konuralp Medical Journal/Konuralp Tip Dergisi, 2017, 9.2.

  BACKGROUND

• 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

• Kwon OY, Jung DY, Kim Y, Cho SH, Yi CH. Effects of ankle exercise combined with deep breathing on blood flow velocity in the femoral vein. Aust J Physiother. 2003;49(4):253-8. doi: 10.1016/s0004-9514(14)60141-0.

  PMID: 14632624 BACKGROUND

• Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016 Mar 31;5:381. doi: 10.1186/s40064-016-2039-2. eCollection 2016.

  PMID: 27066388 BACKGROUND

MeSH Terms

Conditions

Edema; Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Özlem Çinar Özdemir

  Izmir Democracy University

  STUDY DIRECTOR

• Gülşah BARĞI

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Cemre GÖRÜNMEZOĞLU, MSc

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Dündar Özalp KARABAY

  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

Model Details: Assessment

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 15, 2023
• Study Start: July 20, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 24, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)