The GET FIT trial (NCT01635413): A randomized controlled trial of strength training versus Tai Ji Quan for fall prevention among female cancer survivors.

Abstract

12059 Background: Women with cancer are significantly more likely to fall than women without cancer but there are not yet any evidence-based fall prevention strategies that specifically target cancer survivors. The GET FIT trial compares the efficacy of two distinct types of exercise, strength training vs. tai ji quan, to prevent falls in women finished with chemotherapy. Methods: We conducted a 3 group, single-blind, parallel design, randomized controlled trial in older, inactive women cancer survivors treated with chemotherapy. Women were randomly assigned to 1 of 3 intervention groups: 1) strength training, 2) tai ji quan or 3) a placebo control group (stretching) that trained 2x/week for 6 months. Additional follow-up occurred 6 months after formal training stopped. The primary outcome was fall rate across 6-and 12 months; secondary outcomes, reflective of training fidelity, were maximal leg strength (by 1-repetition maximum) and dynamic postural control (by computerized dynamic posturography), collected at 0, 3, and 6 months. Results: 442 women (mean age 62.4 + 6.3 yrs.) were enrolled and randomly assigned to study groups. Over the 6 months prior to enrollment, 21% of the sample (n = 94) reported at least one fall (of which, 37% (n = 35) reported two or more falls)), and 12% (n = 51) reported at least one injurious fall. Retention across the 12 months study period was 88%, while adherence to the study interventions over 6 months averaged 73%, 71%, and 74% for the strength, tai ji quan and stretching (control) groups, respectively. 26% of the sample (n = 99 of 382) reported at least one fall during the intervention and 27% (n = 102) reported falls during follow up. Using regression models, there were no significant differences in the odds of having at least one fall during the intervention period (1-6 months) or across the entire follow-up period (1-12 months) between the control and either the strength or tai ji quan groups. At 6 months, the strength group showed a greater increase from baseline in maximal leg strength (+14.3 kg, 95% CI: 11.4-17.1) than the control group (+7.5 kg, 95% CI: 4.6-10.4, p = 0.002). Whereas, the tai ji quan group showed a greater increase in dynamic postural control (+2.42%, 95% CI: 1.36-3.48) compared to the control group (+0.35%, 95% CI: -0.69-1.38, p = 0.007). Conclusions: Despite evidence for fidelity of strength and tai ji quan training to improve muscle strength and postural control, respectively, neither program significantly lowered fall rates over a placebo control group. It is possible that the dose of exercise was too low and/or the sample was not at high risk of falls. The etiology of fall risk in women cancer survivors needs to be better understood as it may differ from risk factors in older adults. Future trials should consider patient-centered, tailored fall-prevention interventions for cancer survivors based on identified fall risk factors. Clinical trial information: NCT01635413.