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Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

28 agosto 2026 aggiornato da: Alp Ozel, Abant Izzet Baysal University

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

The goal of this clinical trial is to learn whether a structured home-based exercise and education program can improve quality of life and leg symptoms in adults with chronic venous insufficiency. Chronic venous insufficiency occurs when the veins in the legs do not return blood effectively toward the heart. The main questions the study aims to answer are: Does the exercise and education program improve quality of life related to chronic venous insufficiency after 8 weeks, and is any improvement maintained at Week 12? Does the program reduce leg symptoms after 8 weeks, and is any improvement maintained at Week 12? Researchers will compare participants who receive the structured exercise and education program in addition to standard medical care with participants who receive standard medical care and routine lifestyle advice without structured exercise training. A total of 120 participants will be assigned by chance to one of the two groups. Participants will: Continue the standard medical care recommended by their physicians. Attend assessments at the beginning of the study, at Week 8, and at Week 12. Complete questionnaires and tests assessing quality of life, leg symptoms, walking capacity, calf muscle endurance, physical activity, pain, heaviness, and lower-limb swelling. Participants assigned to the intervention group will also attend a 30- to 45-minute group education session, perform home-based exercises for 20 to 30 minutes per day on at least 5 days per week for 8 weeks, record their exercise sessions, and receive weekly follow-up by telephone or message.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The sample size was calculated using R version 4.5.3 with the pwr package. Previously published VEINES-QOL change data suggested a standardized effect size of approximately 0.72. However, because this estimate was derived from a single small study with very low-certainty evidence, a more conservative effect size of Cohen's d = 0.55 was prespecified. For a two-sided independent-samples comparison with a significance level of 0.05 and 80% statistical power, 53 participants were required in each group (106 participants in total). The target enrollment was increased to 120 participants to allow for potential attrition. The allocation sequence will be generated before participant enrollment by a staff nurse designated to manage the allocation process, using a prespecified script based on the blockrand package in R version 4.5.3, with a 1:1 allocation ratio and randomly varying block sizes. The designated staff nurse will otherwise not be involved in eligibility assessment, participant enrollment, intervention delivery, or outcome assessment. The sequence will be maintained in a password-protected electronic allocation system accessible only to the designated staff nurse. After eligibility has been confirmed, written informed consent has been obtained, and baseline assessments have been completed, the enrolling researcher will submit the participant's unique study identification number for allocation. The system will release only the assignment for the current participant, while future assignments will remain concealed. Repeated-measures data will be analyzed using linear mixed-effects models. Group, time, and the group-by-time interaction will be included as fixed effects, with participant-specific random effects included as appropriate. Statistical tests will be two-sided, with the significance level set at 0.05.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
    • Bolu
      • Bolu, Bolu, Turchia (Türkiye), 14030
        • Reclutamento
        • Bolu Abant İzzet Baysal University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Standard Care (in control arm)
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.
Sperimentale: 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.
Comportamentale: Structured Home-Based Exercise and Education Program
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in VEINES-QOL Score
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Change in VEINES-Sym Score
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Six-Minute Walk Distance
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Change in Heel Rise Test Repetitions
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Change in IPAQ-SF Total Physical Activity
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Change in Lower-Extremity Volume
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Change in Pain Intensity
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Change in Lower-Extremity Heaviness
Lasso di tempo: Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Exercise Adherence Rate
Lasso di tempo: Throughout the 8-week intervention period.
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.
Throughout the 8-week intervention period.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Abant Izzet Baysal University

Investigatori

  • Investigatore principale: Alp Özel, PhD, Abant Izzet Baysal University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 agosto 2026

Completamento primario (Stimato)

21 settembre 2027

Completamento dello studio (Stimato)

21 settembre 2027

Date di iscrizione allo studio

Primo inviato

18 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 agosto 2026

Primo Inserito (Effettivo)

21 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AIBU-FTR-AO-06
  • 2026-SOS-05 (Altro numero di sovvenzione/finanziamento: Bolu Abant Izzet Baysal University Scientific Research Projects Coordination Unit)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data underlying the results reported in the primary publication will be shared. These data will include demographic and baseline clinical characteristics, allocated study group, VEINES-QOL and VEINES-Sym scores, Six-Minute Walk Test distance, Heel Rise Test repetitions, IPAQ-SF total physical activity, pain and lower-extremity heaviness scores, lower-extremity volume, exercise adherence, adverse events, withdrawal status, and outcome data collected at the relevant study time points. A data dictionary and coding guide will accompany the dataset. Direct identifiers and free-text information that could permit participant re-identification will not be shared. Only data from participants whose consent permits data sharing will be included.

Periodo di condivisione IPD

Data will become available following publication of the primary study results and will remain available for 5 years.

Criteri di accesso alla condivisione IPD

De-identified individual participant data and supporting documents will be made available to qualified researchers upon reasonable request to the principal investigator. Requests should include a research proposal describing the purpose of the planned analysis. Access will be granted for scientifically appropriate purposes, subject to applicable ethical and institutional requirements and a data use agreement where required.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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