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Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

I

Istanbul University - Cerrahpasa (IUC)

Status

Completed

Conditions

Chronic Venous Insufficiency

Treatments

Other: Exercise Training
Other: Compression Therapy
Other: Massage
Other: Neuromuscular Electrical Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05383469
99984023-302.14.68-

Details and patient eligibility

About

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

Full description

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.

Enrollment

66 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 3 patient groups

Compression Group
Active Comparator group
Description:
Routine compression therapy will be administered.
Treatment:
Other: Compression Therapy
Active Group
Experimental group
Description:
Exercise training will be administered.
Treatment:
Other: Exercise Training
Other: Compression Therapy
Passive Group
Experimental group
Description:
Massageand neuromuscular electrical stimulation will be administered.
Treatment:
Other: Compression Therapy
Other: Neuromuscular Electrical Stimulation
Other: Massage

Trial contacts and locations

1

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Central trial contact

Saliha Gürdal Karakelle, MSc; İpek Yeldan Karagöz, PhD

Data sourced from clinicaltrials.gov

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