NCT04215133

Brief Summary

The aim of this study was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Fourty-two volunteer patients with venous insufficiency will include in the study were randomly divided into three groups as inspiratory exercise, calf muscle exercise and control. While the control group will receive only compression therapy, the inspiratory exercise group will apply inspiratory muscle training consisted of strengthening exercise in addition to compression therapy; kalf muscle exercise group will apply strengthening exercise for calf muscle in addition to compression therapy for 2 days/week with physiotherapist and 3 days/week by themselves, 8 weeks. All the patients will assess with Chronic Venous Disease Quality of life Questionnaire-20 (CIVIQ-20), Nottingham Health Profile, Photopletismograph, Venous Clinical Severity Score (VCSS), hand-held dynamometer, Visual Analogue Scale (VAS), circumference measurements, 6-minute walk test (6MWT), before and after the treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

December 25, 2019

Last Update Submit

May 14, 2021

Conditions

Venous Insufficiency

Keywords

venous insufficiencyexercise therapyinspiratory musclekalf musclevenous return

Outcome Measures

Primary Outcomes (2)

  • The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)

    Quality of life

    12 months

  • Photoplethysmograph (PPG)

    venous return time

    12 months

Secondary Outcomes (5)

  • Hand held dynamometer

    12 months

  • Venous Clinical Severity Score (VCSS)

    12 months

  • 6 minutes walk test

    12 months

  • digital goniometer

    12 months

  • visual analog scale

    12 months

Study Arms (3)

İnspiratory muscle training group

EXPERIMENTAL
Other: exercise therapy

Calf muscle training group

EXPERIMENTAL
Other: exercise therapy

Control

NO INTERVENTION

Interventions

exercise therapyOTHER

inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time.

Calf muscle training groupİnspiratory muscle training group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of venous insufficiency between 18-75 years with duplex ultrasound imaging
  • CEAP classification used in venous insufficiency is C2-C3-C4-C5
  • Having written and verbal communication in Turkish

You may not qualify if:

  • Acute deep vein thrombosis
  • The presence of ulceration
  • Being in class III and IV according to the New York Heart Association classification
  • Presence of respiratory failure
  • Undergoing chemotherapy due to the presence of any cancer
  • Being in the process of treatment for neurological, orthopedic or rheumatologic diseases including lower extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34959, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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: 35710091DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

GAMZE AYDIN, MSc

CONTACT

+905377600256gmzetsn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

December 25, 2019

First Posted

January 2, 2020

Study Start

July 3, 2019

Primary Completion

May 14, 2021

Study Completion

May 20, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)