NCT03755180

Brief Summary

The aim of this study is to evaluate the effects of exercise training in addition to compression therapy on clinical severity, vein diameter, reflux and quality of life in venous insufficiency patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2019

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

November 23, 2018

Last Update Submit

December 29, 2020

Conditions

Venous Insufficiency

Keywords

Venous InsufficiencyExerciseCompression BandagesDuplex Doppler Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20

    CIVIQ 20 is a disease-related quality of life assessment form especially for chronic venous insufficiency patients. The total score is at least 0 and at most 100, and the higher scores indicate better quality of life.

    Change from Baseline Quality of Life at 6 weeks.

Secondary Outcomes (8)

  • Duplex Ultrasonography

    Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.

  • Venous Clinical Severity Score (VCSS)

    Assessment is performed at baseline and six weeks rehabilitation program.

  • Visual Analogue Scale (VAS)

    Assessment is performed at baseline and six weeks rehabilitation program.

  • The 6 Minute Walk Test

    Assessment is performed at baseline and six weeks rehabilitation program.

  • 10-Meter Walk Test

    Assessment is performed at baseline and six weeks rehabilitation program.

  • +3 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Exercise Group

Other: Exercise TrainingOther: Compression Therapy

Group 2

ACTIVE COMPARATOR

Compression Group

Other: Compression Therapy

Interventions

Exercise TrainingOTHER

In exercise training, aerobic exercise and strengthening exercises, especially for gastrocnemius and tibialis anterior muscles, will be applied to the patients. In addition the exercise training, Compression Therapy is applied to patients.

Group 1
Compression TherapyOTHER

Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.

Group 1Group 2

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of venous insufficiency with duplex ultrasonography
  • Classification of CEAP (Clinical-Etiological-Anatomical-Pathological) used in venous insufficiency is C3-C4-C5-C6
  • Ankle-brachial index (ABI) is less than 0.7
  • Possibility to communicate in written and verbal in Turkish
  • Have a level of cognitive ability to understand the instructions given

You may not qualify if:

  • Presence of deep vein thrombosis
  • Ulceration or open burn wound in lower extremity greater than 4 cm
  • Presence of infected ulceration
  • Cardiorespiratory insufficiency
  • Orthopedic, rheumatologic or neurological comorbidities restrain the exercise in lower extremity
  • Presence of a psychiatric illness requiring the use of prescribed medicines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Venous InsufficiencyMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Saliha Gürdal

    Istanbul University Health Sciences Institute

    PRINCIPAL INVESTIGATOR

  • İpek Yeldan

    Istanbul University Faculty of Health Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

November 23, 2018

First Posted

November 27, 2018

Study Start

November 28, 2018

Primary Completion

June 17, 2019

Study Completion

June 17, 2019

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)