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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in VEINES-QOL Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Structured Home-Based Exercise and Education Program (Behavioral)
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.
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Change in VEINES-QOL Score
时间窗: 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.
Change in VEINES-Sym Score
时间窗: 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.
次要结局
- Change in Six-Minute Walk Distance(Baseline, Week 8, and Week 12)
- Change in Heel Rise Test Repetitions(Baseline, Week 8, and Week 12)
- Change in IPAQ-SF Total Physical Activity(Baseline, Week 8, and Week 12)
- Change in Lower-Extremity Volume(Baseline, Week 8, and Week 12)
- Exercise Adherence Rate(hroughout the 8-week intervention period.)
- Change in Pain Intensity(Baseline, Week 8, and Week 12)
- Change in Lower-Extremity Heaviness(Baseline, Week 8, and Week 12)
- Exercise Adherence Rate(Throughout the 8-week intervention period.)
研究者
Alp Ozel
Assistant Professor
Abant Izzet Baysal University