Relatıonshıp Between Pelvıc Floor and Venous Insuffıcıency

NCT07478406 | Enrolling By Invitation

• 2 other identifiers: Pelvic Floor CirculationResearcher
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Chronic Venous Insufficiency, Pelvic Floor, Exercise

Keywords

Venous Insufficiency; Exercise; Compression Bandages

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 weeks

Study Arms (2)

Home exercise group

ACTIVE COMPARATOR

Participants in this group will be given a home exercise program. Participants are asked to do 5 minutes of warm-up exercises beforehand. Participants will perform 10 repetitions of wall-supported toe raises targeting the quadriceps muscle while standing, and 10 repetitions of leg lifts with one leg bent and the other leg straight while lying on their back. Participants will perform 10 wall-supported squats while standing. Ten repetitions of hip extension will be performed while standing with support from the wall, facing the wall. These exercises will be performed separately for each leg. Taking into account the individuals' right to healthcare, if requested, the exercise program will continue for 6 weeks after the 6-week study period is completed.

Diagnostic Test: control group

Group/ pelvic floor exercises

ACTIVE COMPARATOR

Participants in this group will undergo a 20-minute exercise program twice a week via online platforms (Zoom, WhatsApp). The exercise program will consist of pelvic floor exercises. Participants are asked to do 5 minutes of warm-up exercises beforehand. Participants will exhale to their expiratory reserve volume, hold their breath (apnea) 10 times. They will perform 10 repetitions of hip lifts in bed. They will perform 10 repetitions of knee-supported adduction and abduction exercises in a lying position. Pelvic floor exercises will be performed for approximately 6-8 seconds. These exercises will be performed separately for each leg. Cool-down exercises will be performed under patient control. The exercise program will continue for 6 weeks. Participants will continue to wear compression stockings throughout the 6-week period. Participants will continue to perform the exercises on other days according to the home exercise protocol provided to them.

Diagnostic Test: Pelvic exercise group

Interventions

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.

Also known as: Exercise, Doppler ultrasound

Group/ pelvic floor exercises

control group DIAGNOSTIC_TEST

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

Also known as: exercises

Home exercise group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Istanbul Arel University: lead
• Bahçeşehir University: collaborator

Study Sites (1)

Bahçeşehir University Department of Physiotherapy and Rehabilitation

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Venous Insufficiency

Interventions

Exercise; Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted on 32 individuals aged 30-65 who meet the inclusion criteria. In the pelvic floor group, exercise, compression stockings, and pelvic floor exercises will be performed, while in the control group, exercise and compression stockings will be applied. Compression stockings will be worn for a minimum of 9 hours per day, based on the literature. Follow-up will be recorded based on physician evaluation. The 16-person pelvic floor exercise group will have 2 sessions per week for 6 weeks. The 16-person control group will be followed up with an exercise program and compression stockings (9 hours or more) worn at the frequency and duration deemed appropriate by the physician. Exercise compliance in both groups will be monitored using an exercise diary form. This form will be completed over 6 weeks. Both groups will be provided with hand exercise brochures to ensure error-free home exercise protocols. The study will be randomized into two groups: the pelvic exercise gro

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 17, 2026
• Study Start: March 5, 2026
• Primary Completion: March 28, 2026
• Study Completion: April 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)