School of Nursing, Oregon Health & Science University, Portland, OR 97239, USA.
BMC Cancer. 2012 Dec 5;12:577. doi: 10.1186/1471-2407-12-577.
Women with cancer are significantly more likely to fall than women without cancer placing them at higher risk of fall-related fractures, other injuries and disability. Currently, no evidence-based fall prevention strategies exist that specifically target female cancer survivors. The purpose of the GET FIT (Group Exercise Training for Functional Improvement after Treatment) trial is to compare the efficacy of two distinct types of exercise, tai chi versus strength training, to prevent falls in women who have completed treatment for cancer. The specific aims of this study are to: 1) Determine and compare the efficacy of both tai chi training and strength training to reduce falls in older female cancer survivors, 2) Determine the mechanism(s) by which tai chi and strength training each reduces falls and, 3) Determine whether or not the benefits of each intervention last after structured training stops.
METHODS/DESIGN: We will conduct a three-group, single-blind, parallel design, randomized controlled trial in women, aged 50-75 years old, who have completed chemotherapy for cancer comparing 1) tai chi 2) strength training and 3) a placebo control group of seated stretching exercise. Women will participate in supervised study programs twice per week for six months and will be followed for an additional six months after formal training stops. The primary outcome in this study is falls, which will be prospectively tracked by monthly self-report. Secondary outcomes are maximal leg strength measured by isokinetic dynamometry, postural stability measured by computerized dynamic posturography and physical function measured by the Physical Performance Battery, all measured at baseline, 3, 6 and 12 months. The sample for this trial (N=429, assuming 25% attrition) will provide adequate statistical power to detect at least a 47% reduction in the fall rate over 1 year by being in either of the 2 exercise groups versus the control group.
The GET FIT trial will provide important new knowledge about preventing falls using accessible and implementable exercise interventions for women following chemotherapy for cancer. ClinicalTrials.gov NCT01635413.
患有癌症的女性比没有癌症的女性更容易摔倒，这使她们面临更高的跌倒相关骨折、其他伤害和残疾风险。目前，没有针对女性癌症幸存者的循证跌倒预防策略。GET FIT（治疗后功能性团体锻炼）试验的目的是比较两种不同类型的运动，即太极拳与力量训练，以预防已完成癌症治疗的女性跌倒。本研究的具体目的是：1）确定并比较太极拳训练和力量训练在减少老年女性癌症幸存者跌倒方面的效果，2）确定太极拳和力量训练各自减少跌倒的机制，3）确定每个干预措施在结构训练停止后是否仍具有益处。
方法/设计：我们将对年龄在 50-75 岁之间、已完成癌症化疗的女性进行一项三组、单盲、平行设计、随机对照试验，比较 1）太极拳、2）力量训练和 3）坐姿伸展运动的安慰剂对照组。女性将参加每周两次的监督研究计划，为期六个月，并在正式培训停止后再随访六个月。本研究的主要结果是跌倒，将通过每月的自我报告进行前瞻性跟踪。次要结果是通过等速测力计测量最大腿部力量、通过计算机动态姿势描记术测量姿势稳定性以及通过物理表现电池测量身体功能，所有结果均在基线、3、6 和 12 个月时测量。该试验的样本（N=429，假设 25%的流失率）将通过在 2 个运动组中的任何一个与对照组相比，提供足够的统计能力来检测至少 47%的跌倒率在 1 年内降低。
GET FIT 试验将为使用可及和可实施的运动干预措施为接受过癌症化疗的女性预防跌倒提供重要的新知识。ClinicalTrials.gov NCT01635413。
