Schmitz Kathryn H, Troxel Andrea B, Dean Lorraine T, DeMichele Angela, Brown Justin C, Sturgeon Kathleen, Zhang Zi, Evangelisti Margaret, Spinelli Bryan, Kallan Michael J, Denlinger Crystal, Cheville Andrea, Winkels Renate M, Chodosh Lewis, Sarwer David B
Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.
Department of Biostatistics, New York University School of Medicine, New York.
JAMA Oncol. 2019 Nov 1;5(11):1605-1613. doi: 10.1001/jamaoncol.2019.2109.
To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes.
To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial ) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018.
A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs.
The 12-month change in the percentage of interlimb volume difference.
Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group.
Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes.
ClinicalTrials.gov identifier: NCT01515124.
据我们所知，尚无随机临床试验评估体重减轻与家庭锻炼计划相结合对淋巴水肿结果的影响。
评估超重乳腺癌幸存者的体重减轻、家庭锻炼以及体重减轻与家庭锻炼相结合对临床淋巴水肿结果的影响。
设计、地点和参与者：这项针对351名患有乳腺癌相关淋巴水肿（BCRL）的超重乳腺癌幸存者的随机临床试验（稳定运动研究中的女性[WISER]幸存者临床试验）于2012年3月12日至2016年5月28日在学术和社区医院的会议室以及参与者家中进行；从干预开始进行为期1年的随访。2018年9月26日至2018年10月28日进行了意向性治疗的统计分析。
一项为期52周的家庭锻炼计划，包括每周两次力量/阻力训练和每周180分钟的步行，一项为期20周的代餐和52周生活方式改变咨询的体重减轻计划，以及家庭锻炼和体重减轻计划的组合。
四肢体积差异百分比的12个月变化。
351名参与者中，90名被随机分配到对照组（基于机构的淋巴水肿护理，无家庭锻炼或体重减轻干预），87名被分配到锻炼干预组，87名被分配到体重减轻干预组，87名被分配到锻炼与体重减轻联合干预组；218名（62.1%）为白人，122名（34.8%）为黑人，11名（3.1%）为其他种族或族裔。自乳腺癌诊断以来的中位时间为6年（范围1 - 29年）。客观临床评估中上肢总评分的平均（标准差）变化在对照组为 -1.40（11.10），锻炼组为 -2.54（13.20），体重减轻组为 -3.54（12.88），联合组为 -3.84（10.09）。自我报告调查中上肢总体评分的平均（标准差）变化在对照组为 -0.39（2.33），锻炼组为 -0.12（2.14），体重减轻组为 -0.57（2.47），联合组为 -0.62（2.38）。对照组自基线以来的体重减轻为 -0.55%（95%CI， -2.22%至1.11%），联合组为 -8.06%（95%CI， -9.82%至6.29%），体重减轻组为 -7.37%（95%CI， -8.90%至 -5.84%），锻炼组为 -0.44%（95%CI， -1.81%至0.93%）。
研究结果表明，体重减轻、家庭锻炼以及联合干预并未改善BCRL结果；与家庭锻炼计划相比，有监督的基于机构的锻炼计划可能对改善淋巴水肿结果更有益。
ClinicalTrials.gov标识符：NCT01515124 。
