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| ID | Type | Description | Link |
|---|---|---|---|
| Researcher | Other Identifier | Bahçeşehir University |
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| Name | Class |
|---|---|
| Bahçeşehir University | OTHER |
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• 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahçeşehir University Department of Physiotherapy and Rehabilitation | Istanbul | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D018608 | Ultrasonography, Doppler |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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
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| control group | Diagnostic Test | This group will be randomly assigned to receive a home exercise program and an exercise and compression stocking diary application. |
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| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |