Structured Home-Based Exercise and Education for Chronic Venous Insufficiency
Effects of a Structured Home-Based Exercise and Education Program on Clinical and Functional Outcomes in Individuals With Chronic Venous Insufficiency: A Randomized Controlled Trial
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Alp Özel, PhD
- Numer telefonu: 6155 +903742534520
- E-mail: alpozel@ibu.edu.tr
Lokalizacje studiów
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Bolu
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Bolu, Bolu, Turcja (Türkiye), 14030
- Rekrutacyjny
- Bolu Abant İzzet Baysal University
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Kontakt:
- Alp Özel, PhD
- Numer telefonu: 6155 +903742534520
- E-mail: alpozel@ibu.edu.tr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Aged 18 years or older
- Physician-confirmed diagnosis of chronic venous insufficiency
- CEAP clinical class C1-C4
- Ability to walk independently
- Ability to understand written and verbal instructions and participate in the group education and home-based exercise program
- Provision of written informed consent
- Symptomatic chronic venous disease affecting at least one lower limb
- Clinically stable and medically suitable for light-to-moderate exercise
Exclusion Criteria:
- Active or healed venous ulcer (CEAP clinical class C5 or C6)
- Acute deep vein thrombosis or active thromboembolic disease
- Lower-extremity surgery within the previous 3 months
- Severe peripheral arterial disease
- Uncontrolled cardiac, pulmonary, metabolic, or systemic disease
- Neurological, orthopedic, or vestibular disorder that prevents performance of the prescribed exercises or walking tests
- Pregnancy
- Participation in another regular exercise or rehabilitation program during the study
- Severe cognitive, psychiatric, or communication disorder that could prevent adherence to the study protocol
- Active lower-extremity infection, cellulitis, or acute superficial vein thrombosis
- Coexisting lymphedema or lower-extremity edema primarily attributable to a non-venous cause
- Planned venous surgery, endovenous ablation, sclerotherapy, or another venous intervention during the 12-week study period
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Aktywny komparator: Control Group
Participants assigned to this arm will continue their physician-prescribed standard medical treatment and receive routine lifestyle recommendations for the management of chronic venous insufficiency.
They will not receive the structured group education session, study-specific home-based exercise program, or weekly adherence monitoring provided to the experimental group.
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Standard care consists of physician-prescribed medical treatment and routine lifestyle recommendations for chronic venous insufficiency.
Participants in the experimental arm will receive the structured home-based exercise and education program in addition to standard care.
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Eksperymentalny: Structured Home-Based Exercise and Education Group
Participants in this arm will continue their physician-prescribed standard medical treatment and receive a structured exercise and education program.
The program will begin with a 30- to 45-minute face-to-face group session led by a physiotherapist.
The session will include education about chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when recommended by a physician.
Participants will also receive instruction and supervised practice in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching exercises.
They will perform the exercise program at home for 20 to 30 minutes per day on at least 5 days per week for 8 weeks.
Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message and documented using a daily exercise log.
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The intervention will be provided in addition to standard medical care.
Participants will attend a 30- to 45-minute face-to-face group education and practical training session led by a physiotherapist.
Education will cover chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when prescribed.
Participants will receive practical training in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching.
Correct exercise performance will be checked individually.
Participants will perform the program at home for 20 to 30 minutes per day, at least 5 days per week, for 8 weeks.
Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in VEINES-QOL Score
Ramy czasowe: Baseline, Week 8, and Week 12
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VEINES-QOL is the 25-item quality-of-life summary score derived from the 26-item VEINES-QOL/Sym questionnaire.
It assesses the impact of chronic venous disease on symptoms, daily activities, and psychological well-being during the previous 4 weeks.
Scores will be transformed to a 0-100 scale, with higher scores indicating better disease-specific quality of life.
Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement.
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Baseline, Week 8, and Week 12
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Change in VEINES-Sym Score
Ramy czasowe: Baseline, Week 8, and Week 12
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VEINES-Sym is the 10-item symptom summary score derived from the 26-item VEINES-QOL/Sym questionnaire.
It assesses the frequency and severity of venous disease-related symptoms during the previous 4 weeks.
Scores will be transformed to a 0-100 scale, with higher scores indicating fewer or less severe symptoms.
Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate symptom improvement.
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Baseline, Week 8, and Week 12
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Six-Minute Walk Distance
Ramy czasowe: Baseline, Week 8, and Week 12
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The Six-Minute Walk Test will be used to assess submaximal functional exercise capacity.
Participants will be instructed to walk as far as possible for 6 minutes along a flat corridor of at least 30 meters.
The total distance walked will be recorded in meters.
Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement in functional exercise capacity.
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Baseline, Week 8, and Week 12
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Change in Heel Rise Test Repetitions
Ramy czasowe: Baseline, Week 8, and Week 12
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The Heel Rise Test will be used to assess calf muscle endurance and plantar flexor function.
Participants will stand on one leg and perform as many heel-rise repetitions as possible according to a standardized protocol.
The number of correctly completed repetitions will be recorded, and the same lower extremity will be assessed at each visit.
Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement in calf muscle endurance.
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Baseline, Week 8, and Week 12
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Change in IPAQ-SF Total Physical Activity
Ramy czasowe: Baseline, Week 8, and Week 12
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The International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a 7-item self-report questionnaire that assesses physical activity performed during the previous 7 days.
The reported frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity will be used to calculate total physical activity in metabolic equivalent minutes per week (MET-min/week) according to the IPAQ scoring protocol.
Higher values indicate a greater level of physical activity.
Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate increased physical activity.
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Baseline, Week 8, and Week 12
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Change in Lower-Extremity Volume
Ramy czasowe: Baseline, Week 8, and Week 12
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Lower-extremity volume will be estimated from serial circumference measurements using the truncated-cone method.
The index limb will be selected before randomization: the affected limb in unilateral disease, the limb with the higher CEAP class in bilateral disease, or the right limb if CEAP classes are equal.
With the participant standing, circumferences will be measured using a non-elastic tape from 4 cm above the floor proximally at 4-cm intervals to just below the knee joint line.
If the final interval is shorter than 4 cm, its actual length will be used.
Segment volumes will be calculated and summed to obtain total volume in milliliters.
The same limb and measurement levels will be used at all visits.
Higher values indicate greater edema.
Change from baseline will be assessed at Weeks 8 and 12; a reduction indicates improvement.
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Baseline, Week 8, and Week 12
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Change in Pain Intensity
Ramy czasowe: Baseline, Week 8, and Week 12
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Lower-extremity pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with anchors of 0 mm indicating no pain and 100 mm indicating the most severe pain.
Higher scores indicate greater pain intensity.
Change from baseline will be evaluated at Weeks 8 and 12; a reduction in the score indicates improvement.
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Baseline, Week 8, and Week 12
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Change in Lower-Extremity Heaviness
Ramy czasowe: Baseline, Week 8, and Week 12
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Perceived lower-extremity heaviness will be assessed using a 100-mm Visual Analog Scale (VAS), with anchors of 0 mm indicating no heaviness and 100 mm indicating the most severe heaviness.
Higher scores indicate greater symptom severity.
Change from baseline will be evaluated at Weeks 8 and 12; a reduction in the score indicates improvement.
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Baseline, Week 8, and Week 12
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Exercise Adherence Rate
Ramy czasowe: Throughout the 8-week intervention period.
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Exercise adherence will be assessed in the experimental group using daily exercise logs reviewed during weekly telephone calls or text-message follow-ups.
An exercise day will be considered completed when the participant reports performing the prescribed home-based program for at least 20 minutes.
The adherence rate will be calculated as the number of completed exercise days divided by 40 prescribed exercise days (5 days per week for 8 weeks), multiplied by 100.
Values will range from 0% to 100%, with higher percentages indicating greater adherence.
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Throughout the 8-week intervention period.
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Alp Özel, PhD, Abant Izzet Baysal University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Objawy neurologiczne
- Choroby Układu Nerwowego
- Choroby oczu
- Zaburzenia widzenia
- Zaburzenia czucia
- Ślepota
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Ślepota, korowy
- Administracja usług zdrowotnych
- Jakość opieki zdrowotnej, dostęp i ocena
- Jakość opieki zdrowotnej
- Wskaźniki jakości, opieka zdrowotna
- Standard opieki
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- AIBU-FTR-AO-06
- 2026-SOS-05 (Inny numer grantu/finansowania: Bolu Abant Izzet Baysal University Scientific Research Projects Coordination Unit)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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