Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

NCT ID: NCT05383469

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-09-02

Brief Summary

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

Detailed Description

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Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Cardiovascular Surgery Department will be included this study.

Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In all groups, a common evaluation protocol will be applied to the patients.

Compression therapy will be applied to the first group. Active treatment in addition to compression therapy will be applied to the second group. Passive treatment in addition to compression therapy will be applied to the third group.

Conditions

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Chronic Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Compression Group

Routine compression therapy will be administered.

Group Type ACTIVE_COMPARATOR

Compression Therapy

Intervention Type OTHER

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 Group

Exercise training will be administered.

Group Type EXPERIMENTAL

Exercise Training

Intervention Type OTHER

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

Compression Therapy

Intervention Type OTHER

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.

Passive Group

Massageand neuromuscular electrical stimulation will be administered.

Group Type EXPERIMENTAL

Massage

Intervention Type OTHER

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

Neuromuscular Electrical Stimulation

Intervention Type OTHER

Symmetrical biphasic current at a frequency of 30-85 Hz

Compression Therapy

Intervention Type OTHER

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.

Interventions

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Exercise Training

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

Intervention Type OTHER

Massage

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

Intervention Type OTHER

Neuromuscular Electrical Stimulation

Symmetrical biphasic current at a frequency of 30-85 Hz

Intervention Type OTHER

Compression Therapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Saliha Gürdal Karakelle

Research .Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University-Cerrahpasa

Istanbul, Büyükçekmece, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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99984023-302.14.68-

Identifier Type: -

Identifier Source: org_study_id

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