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Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

2026年8月28日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Alp Özel, PhD
  • 電話番号：6155 +903742534520
  • メール：alpozel@ibu.edu.tr

研究場所

  • トルコ（Türkiye）
    • Bolu
      • Bolu、Bolu、トルコ（Türkiye）、14030
        • 募集
        • Bolu Abant İzzet Baysal University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
他の：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.
実験的：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in VEINES-QOL Score
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Six-Minute Walk Distance
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Abant Izzet Baysal University

捜査官

  • 主任研究者：Alp Özel, PhD、Abant Izzet Baysal University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月28日

一次修了 (推定)

2027年9月21日

研究の完了 (推定)

2027年9月21日

試験登録日

最初に提出

2026年8月18日

QC基準を満たした最初の提出物

2026年8月18日

最初の投稿 (実際)

2026年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月28日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AIBU-FTR-AO-06
  • 2026-SOS-05 (その他の助成金/資金番号：Bolu Abant Izzet Baysal University Scientific Research Projects Coordination Unit)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

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