NCT05383469

Brief Summary

The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

February 9, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

February 9, 2022

Last Update Submit

November 10, 2023

Conditions

Chronic Venous Insufficiency

Keywords

exercisecompressionneuromuscular electrical stimulationmassage

Outcome Measures

Primary Outcomes (1)

  • Circumference measurements

    Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.

    Change from Baseline circumferences at 8 weeks.

Secondary Outcomes (6)

  • Visual Analogue Scale (VAS)

    Assessment will be performed at baseline and at 8 weeks.

  • Venous Clinical Severity Score (VCSS)

    Assessment will be performed tat baseline and at 8 weeks.

  • Handheld Dynamometer

    Assessment will be performed at baseline and at 8 weeks.

  • 6-Minute Walking Test

    Assessment will be performed at baseline and at 8 weeks.

  • 10-Meter Walking Test

    Assessment will be performed at baseline and at 8 weeks.

  • +1 more secondary outcomes

Study Arms (3)

Compression Group

ACTIVE COMPARATOR

Routine compression therapy will be administered.

Other: Compression Therapy

Active Group

EXPERIMENTAL

Exercise training will be administered.

Other: Exercise TrainingOther: Compression Therapy

Passive Group

EXPERIMENTAL

Massageand neuromuscular electrical stimulation will be administered.

Other: MassageOther: Neuromuscular Electrical StimulationOther: Compression Therapy

Interventions

Exercise TrainingOTHER

Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises

Active Group
MassageOTHER

Classical massage including superficial and deep stroking and friction methods for the lower extremity.

Passive Group
Neuromuscular Electrical StimulationOTHER

Symmetrical biphasic current at a frequency of 30-85 Hz

Passive Group
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.

Active GroupCompression GroupPassive Group

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 the 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 University-Cerrahpasa

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseMassage

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

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 .Assistant

Study Record Dates

First Submitted

February 9, 2022

First Posted

May 20, 2022

Study Start

September 13, 2022

Primary Completion

December 25, 2022

Study Completion

September 2, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)