Department of Medicine, Federal University of Alagoas, Arapiraca, Brazil.
Department of Physiology, Federal University of Paraná, Curitiba, Brazil.
Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD010637. doi: 10.1002/14651858.CD010637.pub3.
BACKGROUND: Chronic venous insufficiency (CVI) is a condition related to chronic venous disease that may progress to venous leg ulceration and impair quality of life of those affected. Treatments such as physical exercise may be useful to reduce CVI symptoms. This is an update of an earlier Cochrane Review. OBJECTIVES: To evaluate the benefits and harms of physical exercise programmes for the treatment of individuals with non-ulcerated CVI. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 28 March 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing exercise programmes with no exercise in people with non-ulcerated CVI. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were intensity of disease signs and symptoms, ejection fraction, venous refilling time, and incidence of venous leg ulcer. Our secondary outcomes were quality of life, exercise capacity, muscle strength, incidence of surgical intervention, and ankle joint mobility. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included five RCTs involving 146 participants. The studies compared a physical exercise group with a control group that did not perform a structured exercise programme. The exercise protocols differed between studies. We assessed three studies to be at an overall unclear risk of bias, one study at overall high risk of bias, and one study at overall low risk of bias. We were not able to combine data in meta-analysis as studies did not report all outcomes, and different methods were used to measure and report outcomes. Two studies reported intensity of CVI disease signs and symptoms using a validated scale. There was no clear difference in signs and symptoms between groups in baseline to six months after treatment (Venous Clinical Severity Score mean difference (MD) -0.38, 95% confidence interval (CI) -3.02 to 2.26; 28 participants, 1 study; very low-certainty evidence), and we are uncertain if exercise alters the intensity of signs and symptoms eight weeks after treatment (MD -4.07, 95% CI -6.53 to -1.61; 21 participants, 1 study; very low-certainty evidence). There was no clear difference in ejection fraction between groups from baseline to six months follow-up (MD 4.88, 95% CI -1.82 to 11.58; 28 participants, 1 study; very low-certainty evidence). Three studies reported on venous refilling time. We are uncertain if there is an improvement in venous refilling time between groups for baseline to six-month changes (MD 10.70 seconds, 95% CI 8.86 to 12.54; 23 participants, 1 study; very low-certainty evidence) or baseline to eight-week change (MD 9.15 seconds, 95% CI 5.53 to 12.77 for right side; MD 7.25 seconds, 95% CI 5.23 to 9.27 for left side; 21 participants, 1 study; very low-certainty evidence). There was no clear difference in venous refilling index for baseline to six-month changes (MD 0.57 mL/min, 95% CI -0.96 to 2.10; 28 participants, 1 study; very low-certainty evidence). No included studies reported the incidence of venous leg ulcers. One study reported health-related quality of life using validated instruments (Venous Insufficiency Epidemiological and Economic Study (VEINES) and 36-item Short Form Health Survey (SF-36), physical component score (PCS) and mental component score (MCS)). We are uncertain if exercise alters baseline to six-month changes in health-related quality of life between groups (VEINES-QOL: MD 4.60, 95% CI 0.78 to 8.42; SF-36 PCS: MD 5.40, 95% CI 0.63 to 10.17; SF-36 MCS: MD 0.40, 95% CI -3.85 to 4.65; 40 participants, 1 study; all very low-certainty evidence). Another study used the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), and we are uncertain if exercise alters baseline to eight-week changes in health-related quality of life between groups (MD 39.36, 95% CI 30.18 to 48.54; 21 participants, 1 study; very low-certainty evidence). One study reported no differences between groups without presenting data. There was no clear difference between groups in exercise capacity measured as time on treadmill (baseline to six-month changes) (MD -0.53 minutes, 95% CI -5.25 to 4.19; 35 participants, 1 study; very low-certainty evidence). We are uncertain if exercise improves exercise capacity as assessed by the 6-minute walking test (MD 77.74 metres, 95% CI 58.93 to 96.55; 21 participants, 1 study; very low-certainty evidence). Muscle strength was measured using dynamometry or using heel lifts counts. We are uncertain if exercise increases peak torque/body weight (120 revolutions per minute) (changes from baseline to six months MD 3.10 ft-lb, 95% CI 0.98 to 5.22; 29 participants, 1 study; very low-certainty evidence). There was no clear difference between groups in baseline to eight-week change in strength measured by a hand dynamometer (MD 12.24 lb, 95% CI -7.61 to 32.09 for the right side; MD 11.25, 95% CI -14.10 to 36.60 for the left side; 21 participants, 1 study; very low-certainty evidence). We are uncertain if there is an increase in heel lifts (n) (baseline to six-month changes) between groups (MD 7.70, 95% CI 0.94 to 14.46; 39 participants, 1 study; very low-certainty evidence). There was no clear difference between groups in ankle mobility measured during dynamometry (baseline to six-month change MD -1.40 degrees, 95% CI -4.77 to 1.97; 29 participants, 1 study; very low-certainty evidence). We are uncertain if exercise increases plantar flexion measured by a goniometer (baseline to eight-week change MD 12.13 degrees, 95% CI 8.28 to 15.98 for right leg; MD 10.95 degrees, 95% CI 7.93 to 13.97 for left leg; 21 participants, 1 study; very low-certainty evidence). In all cases, we downgraded the certainty of evidence due to risk of bias and imprecision. AUTHORS' CONCLUSIONS: There is currently insufficient evidence to assess the benefits and harms of physical exercise in people with chronic venous disease. Future research into the effect of physical exercise should consider types of exercise protocols (intensity, frequency, and time), sample size, blinding, and homogeneity according to the severity of disease.
背景:慢性静脉功能不全(CVI)是一种与慢性静脉疾病相关的病症,可能进展为静脉性腿部溃疡,并降低受影响者的生活质量。体育锻炼等治疗方法可能有助于减轻 CVI 症状。这是对先前 Cochrane 综述的更新。
目的:评估非溃疡性 CVI 患者的身体锻炼方案的益处和危害。
检索策略:Cochrane 血管信息专家检索了 Cochrane 血管专题登记册、CENTRAL、MEDLINE、Embase 和 CINAHL 数据库以及世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov 试验注册库,检索日期截至 2022 年 3 月 28 日。
纳入排除标准:我们纳入了比较非溃疡性 CVI 患者的运动方案与不运动的随机对照试验(RCT)。
数据收集与分析:我们使用了标准的 Cochrane 方法。我们的主要结局是疾病体征和症状的严重程度、射血分数、静脉再充盈时间和静脉性腿部溃疡的发生率。我们的次要结局是生活质量、运动能力、肌肉力量、手术干预的发生率和踝关节活动度。我们使用 GRADE 评估每个结局的证据确定性。
主要结果:我们纳入了五项 RCT,涉及 146 名参与者。这些研究比较了物理锻炼组与不进行结构化锻炼方案的对照组。研究之间的锻炼方案不同。我们评估了三项研究的总体不确定偏倚风险,一项研究的总体高偏倚风险,和一项研究的总体低偏倚风险。我们无法对数据进行荟萃分析,因为研究没有报告所有结局,并且使用不同的方法来测量和报告结局。两项研究使用验证过的量表报告了 CVI 疾病体征和症状的严重程度。在治疗后 6 个月时,两组在体征和症状方面没有明显差异(静脉临床严重程度评分平均差值(MD)-0.38,95%置信区间(CI)-3.02 至 2.26;28 名参与者,1 项研究;非常低确定性证据),我们不确定运动是否在治疗后 8 周时改变体征和症状的严重程度(MD-4.07,95% CI-6.53 至-1.61;21 名参与者,1 项研究;非常低确定性证据)。在射血分数方面,两组在基线至 6 个月的随访中没有明显差异(MD 4.88,95% CI-1.82 至 11.58;28 名参与者,1 项研究;非常低确定性证据)。三项研究报告了静脉再充盈时间。我们不确定基线至 6 个月的变化(MD 10.70 秒,95% CI 8.86 至 12.54;23 名参与者,1 项研究;非常低确定性证据)或基线至 8 周的变化(MD 9.15 秒,95% CI 5.53 至 12.77 右;MD 7.25 秒,95% CI 5.23 至 9.27 左;21 名参与者,1 项研究;非常低确定性证据)之间的静脉再充盈时间是否有改善。在基线至 6 个月的变化中,静脉再充盈指数没有明显差异(MD 0.57 mL/min,95% CI-0.96 至 2.10;28 名参与者,1 项研究;非常低确定性证据)。没有纳入的研究报告静脉性腿部溃疡的发生率。一项研究使用验证过的工具(静脉淤滞性皮炎流行病学和经济研究(VEINES)和 36 项简短健康调查(SF-36),身体成分评分(PCS)和心理成分评分(MCS))报告了健康相关生活质量。我们不确定运动是否在 6 个月的基线至变化中改变了两组之间的健康相关生活质量(VEINES-QOL:MD 4.60,95% CI 0.78 至 8.42;SF-36 PCS:MD 5.40,95% CI 0.63 至 10.17;SF-36 MCS:MD 0.40,95% CI-3.85 至 4.65;40 名参与者,1 项研究;全部为非常低确定性证据)。另一项研究使用了慢性静脉疾病生活质量问卷(CIVIQ-20),我们不确定运动是否在 8 周的基线至变化中改变了两组之间的健康相关生活质量(MD 39.36,95% CI 30.18 至 48.54;21 名参与者,1 项研究;非常低确定性证据)。一项研究没有报告两组之间的差异,也没有提供数据。在跑步机上的运动能力(基线至 6 个月的变化)方面,两组之间没有明显差异(MD-0.53 分钟,95% CI-5.25 至 4.19;35 名参与者,1 项研究;非常低确定性证据)。我们不确定运动是否能改善 6 分钟步行试验评估的运动能力(MD 77.74 米,95% CI 58.93 至 96.55;21 名参与者,1 项研究;非常低确定性证据)。肌肉力量使用测力计或使用脚跟升高计数来测量。我们不确定运动是否能增加峰值扭矩/体重(120 转/分钟)(从基线到 6 个月的变化 MD 3.10 英尺-磅,95% CI 0.98 至 5.22;29 名参与者,1 项研究;非常低确定性证据)。在基线至 8 周的变化中,两组在手握式测力计测量的力量方面没有明显差异(MD 12.24 磅,95% CI-7.61 至 32.09 右;MD 11.25,95% CI-14.10 至 36.60 左;21 名参与者,1 项研究;非常低确定性证据)。我们不确定脚跟升高(n)(基线至 6 个月的变化)之间是否有增加(MD 7.70,95% CI 0.94 至 14.46;39 名参与者,1 项研究;非常低确定性证据)。在动态测功计测量的踝关节活动度方面,两组之间没有明显差异(基线至 6 个月的变化 MD-1.40 度,95% CI-4.77 至 1.97;29 名参与者,1 项研究;非常低确定性证据)。我们不确定运动是否能增加跖屈角度(用角度计测量)(基线至 8 周的变化 MD 12.13 度,95% CI 8.28 至 15.98 右;MD 10.95 度,95% CI 7.93 至 13.97 左;21 名参与者,1 项研究;非常低确定性证据)。在所有情况下,我们都因偏倚和不精确而降低了证据的确定性。
作者结论:目前尚无足够证据评估慢性静脉疾病患者进行身体锻炼的益处和危害。未来关于体育锻炼效果的研究应考虑运动方案的类型(强度、频率和时间)、样本量、盲法和根据疾病严重程度进行分组。
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