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
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Studietype
Inschrijving (Geschat)
Inschrijving
Fase
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
Studiecontact
- Naam: Alp Özel, PhD
- Telefoonnummer: 6155 +903742534520
- E-mail: alpozel@ibu.edu.tr
Studie Locaties
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Bolu
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Bolu, Bolu, Turkije (Türkiye), 14030
- Werving
- Bolu Abant İzzet Baysal University
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Contact:
- Alp Özel, PhD
- Telefoonnummer: 6155 +903742534520
- E-mail: alpozel@ibu.edu.tr
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-
Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in VEINES-QOL Score
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Six-Minute Walk Distance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Sponsor
Onderzoekers
Onderzoekers
- Hoofdonderzoeker: Alp Özel, PhD, Abant Izzet Baysal University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Studie start
Primaire voltooiing (Geschat)
Primaire voltooiing
Studie voltooiing (Geschat)
Studie voltooiing
Studieregistratiedata
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Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
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Eerst geplaatst
Updates van studierecords
Laatste update geplaatst (Werkelijk)
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Oogziekten
- Gezichtsstoornissen
- Sensatiestoornissen
- Blindheid
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Blindheid, Corticaal
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Kwaliteitsindicatoren, gezondheidszorg
- Zorgstandaard
Andere studie-ID-nummers
Andere studie-ID-nummers
- AIBU-FTR-AO-06
- 2026-SOS-05 (Ander subsidie-/financieringsnummer: Bolu Abant Izzet Baysal University Scientific Research Projects Coordination Unit)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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