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Enrolling by Invitation

NCT Number: NCT07478406

Relatıonshıp Between Pelvıc Floor and Venous Insuffıcıency

• The aim of the study is to examine the effects of pelvic floor exercises combined with a regular exercise program and compression stockings on symptomatic improvement, capillary circulation, edema, and functional capacity in individuals with chronic venous insufficiency. It is to compare whether these two methods are superior to each other in terms of clinical and functional outcomes. To evaluate the reliability of this combination application, patient compliance, and its contribution to quality of life. In addition to the researcher (doctoral student), a consultant and a research physician will be involved in this study to conduct clinical applications, observe the process, and collect data. The study will be conducted at a single center.

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Key information

Conditions

Chronic Venous Insufficiency, Pelvic Floor, Exercise Behavior Cardiovascular Diseases Motor Activity Vascular Diseases Venous Insufficiency

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahçeşehir University Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

About this study

The aim of this study is to investigate the effects of a regular exercise program combined with compression stocking use versus pelvic floor exercise application on symptomatic improvement, capillary circulation, edema, and functional capacity in individuals with chronic venous insufficiency. It aims to compare whether these two methods are superior to each other in terms of clinical and functional outcomes. It also aims to evaluate the reliability of this combination application, patient compliance, and its contribution to quality of life and hemodynamics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those diagnosed with primary lower extremity venous insufficiency based on Doppler ultrasound measurements
  • Having clinical symptoms and findings
  • Not using any medication for varicose vein treatment
  • Not having undergone varicose vein surgery previously
  • Volunteering to participate in the study
  • Not receiving physical therapy or rehabilitation services for any reason during the study,
  • Possessing the necessary technical equipment and knowledge for telerehabilitation
  • No history of vainismus or chronic pelvic pain

Exclusion criteria

  • DVT
  • Heart failure
  • Thrombophlebitis
  • Venous ulcer
  • Skin pigmentation
  • Lipodermatosclerosis
  • Bleeding varicose vein
  • Open wounds and acute infections
  • Uncontrolled hypertension
  • Orthopedic and neurological diseases that may prevent physical activity
  • Non-cooperative patients with communication problems
  • Failure to comply with the treatment program
  • Pregnancy
  • Having a contraindication for exercise
  • Having communication problems (auditory, visual, etc.)
  • Having difficulty accessing the internet

Treatment and study plan

Pelvic exercise group

Diagnostic Test

The original aspect of the study is that it contributes to the creation of a multidisciplinary treatment protocol by examining the synergistic effects of these two approaches on pelvic floor exercises. It is anticipated that the findings will contribute to the creation of individualized and effective intervention strategies that can serve as a guide for clinicians.

Other names: Exercise, Doppler ultrasound

Control group

Diagnostic Test

This group will be randomly assigned to receive a home exercise program and an exercise and compression stocking diary application.

Other names: exercises

Primary outcomes

  1. The effect of pelvic exercises on lower extremity circulation in patients evaluated with Doppler ultrasound

    Time frame: 6 weeks

    Our study has a randomised, controlled, prospective study design. Participants will be randomly assigned to either the pelvic floor exercise group or the control group using the random.org website and randomisation method. Individuals who sign a voluntary consent form will be evaluated to compare the effects of pelvic floor exercises on the pelvic floor, looking at their superiority over exercise and compression stockings in individuals with chronic venous insufficiency. Individuals will be evaluated face-to-face at a private hospital approved by the ethics committee. The study will report participants' Doppler data, pelvic floor status, and exercise processes. Data will be collected again after a 6-week follow-up period and reported with statistical analysis. The effect of pelvic exercises will be reported here.

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Collaborators

  • Bahçeşehir University

Registry information

Official study title

The Effect of Pelvic Floor Exercises on Venous Function in Chronic Venous Insufficiency: A Doppler Ultrasound Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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