Chronic Venous Insufficiency, Pelvic Floor, ExerciseNCT07478406
Relatıonshıp Between Pelvıc Floor and Venous Insuffıcıency
A study testing Pelvic exercise group in people with Chronic Venous Insufficiency, Pelvic Floor, Exercise, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Venous Insufficiency, Pelvic Floor, Exercise
- What is being tested?
- Pelvic exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2026to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- DVT
- Heart failure
- Thrombophlebitis
- Venous ulcer
- Skin pigmentation
- Lipodermatosclerosis
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bahçeşehir University Department of Physiotherapy and Rehabilitation
Istanbul, Istanbul
About this study
Official title: The Effect of Pelvic Floor Exercises on Venous Function in Chronic Venous Insufficiency: A Doppler Ultrasound Study
- 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.
Read the detailed description
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.
- Being tested
- Pelvic exercise group, control group
- Keywords
- Venous Insufficiency, Exercise, Compression Bandages
- Medical subject headings
- Motor Activity, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic exercise groupDiagnostic test
Also called Exercise, Doppler ultrasound
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.
control groupDiagnostic test
Also called exercises
This group will be randomly assigned to receive a home exercise program and an exercise and compression stocking diary application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Pelvic exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion28 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Insufficiency, Pelvic Floor, ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478406
- Sponsor's protocol ID
- Pelvic Floor Circulation
- Other IDs
- Researcher
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Exercises on Venous Function in Chronic Venous Insufficiency: A Doppler Ultrasound Study
- ClinicalTrials.gov ID
- NCT07478406
- Acronym / sponsor ID
- Pelvic Floor Circulation
- Keywords
- Venous Insufficiency, Exercise, Compression Bandages
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Home exercise group | Active comparator | Diagnostic Test: control groupParticipants 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. |
| Group/ pelvic floor exercises | Active comparator | Diagnostic Test: Pelvic exercise groupParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- DVT
- Heart failure
- Thrombophlebitis
- Venous ulcer
- Skin pigmentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic exercise groupAlso: Exercise, Doppler ultrasoundThe 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. | Diagnostic test | Group/ pelvic floor exercises |
| control groupAlso: exercisesThis group will be randomly assigned to receive a home exercise program and an exercise and compression stocking diary application. | Diagnostic test | Home exercise group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic exercise group in people with Chronic Venous Insufficiency, Pelvic Floor, Exercise, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of pelvic exercises on lower extremity circulation in patients evaluated with Doppler ultrasound (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.