Structured Home-Based Exercise and Education for Chronic Venous Insufficiency
2026년 8월 28일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
120
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Alp Özel, PhD
- 전화번호: 6155 +903742534520
- 이메일: alpozel@ibu.edu.tr
연구 장소
-
-
Bolu
-
Bolu, Bolu, 터키 (Türkiye), 14030
- 모병
- Bolu Abant İzzet Baysal University
-
연락하다:
- Alp Özel, PhD
- 전화번호: 6155 +903742534520
- 이메일: alpozel@ibu.edu.tr
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
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.
|
|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in VEINES-QOL Score
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Six-Minute Walk Distance
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Alp Özel, PhD, Abant Izzet Baysal University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 8월 28일
기본 완료 (추정된)
기본 완료
2027년 9월 21일
연구 완료 (추정된)
연구 완료
2027년 9월 21일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 18일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 18일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 31일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 28일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- AIBU-FTR-AO-06
- 2026-SOS-05 (기타 보조금/기금 번호: Bolu Abant Izzet Baysal University Scientific Research Projects Coordination Unit)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Data will become available following publication of the primary study results and will remain available for 5 years.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .