The Effect of Pelvic Floor Exercises on Venous Function in Chronic Venous Insufficiency: A Doppler Ultrasound Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- The effect of pelvic exercises on lower extremity circulation in patients evaluated with Doppler ultrasound
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Home exercise group
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.
Intervention: control group (Diagnostic Test)
Group/ pelvic floor exercises
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.
Intervention: Pelvic exercise group (Diagnostic Test)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported