School of Rehabilitation Science, Faculty of Health Science, McMaster University, IAHS, 1400 Main St. W, Hamilton, ON, L8S 1C7, Canada.
Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, ON, Canada.
BMC Pulm Med. 2024 Aug 24;24(1):408. doi: 10.1186/s12890-024-03215-2.
Available evidence suggests that adults with chronic obstructive pulmonary disease (COPD) performed substantially worse than healthy controls on many balance measures and balance training can improve the balance measures in this population. We conducted this study to determine the effects of incorporating balance training into pulmonary rehabilitation (PR) on the incidence of falls at 12 months follow-up in high fall risk adults with COPD.
We conducted a prospective international multi-center randomized controlled trial. Eligible participants were adults with COPD at a high risk of future falls and were randomly assigned (1:1) to the intervention or control group. The intervention included personalized balance training for a targeted total of 90 min per week. Both the intervention and control groups received usual PR (2-3 times per week for 8-12 weeks). The primary outcome was the incidence of falls at 12-month follow-up using monthly fall diary calendars. Negative binomial regression or recurrent events models were used to examine the effects of the intervention on fall events. Multiple imputations were performed to deal with missing values.
Of 258 participants who were enrolled in the trial, 178 provided falls information (intervention group = 91, control group = 87) and were included in the main analysis. Forty-one participants (45%) experienced at least one fall event in the intervention group and 33 (38%) in the control group (p = 0.34). The mean incidence of falls at 12 months was similar between the two groups (128 versus 128 per 100 person-years; mean difference: 0.30, 95% CI: -0.76 to 1.36 per 100 person-years). The results are robust after multiple imputations for missing data (n = 67).
PR incorporating balance training compared to PR alone did not reduce the incidence of falls over the 12-month period in high fall risk adults with COPD.
The study was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016.
现有证据表明，慢性阻塞性肺疾病（COPD）患者在许多平衡测试中表现明显差于健康对照组，且平衡训练可改善该人群的平衡测试结果。本研究旨在确定将平衡训练纳入 COPD 患者肺康复（PR）中对 12 个月随访时高跌倒风险成人跌倒发生率的影响。
我们开展了一项前瞻性国际多中心随机对照试验。符合条件的参与者为未来有跌倒风险的 COPD 高风险成人，他们被随机分配（1:1）至干预组或对照组。干预组包括个性化的平衡训练，目标是每周总计 90 分钟。干预组和对照组均接受常规 PR（每周 2-3 次，持续 8-12 周）。主要结局是使用每月跌倒日记日历在 12 个月随访时的跌倒发生率。采用负二项回归或复发性事件模型来检验干预对跌倒事件的影响。采用多重插补法处理缺失值。
在 258 名入组试验的参与者中，有 178 名提供了跌倒信息（干预组=91 名，对照组=87 名），并纳入主要分析。干预组中有 41 名（45%）参与者发生至少 1 次跌倒事件，对照组中有 33 名（38%）参与者发生至少 1 次跌倒事件（p=0.34）。两组 12 个月的跌倒发生率相似（128 次/100 人年vs. 128 次/100 人年；平均差异：0.30，95%CI：-0.76 至 1.36 次/100 人年）。对缺失数据（n=67）进行多重插补后，结果仍然稳健。
与单独 PR 相比，将平衡训练纳入 PR 并未降低 COPD 高跌倒风险成人在 12 个月期间的跌倒发生率。
该研究于 2016 年 12 月 14 日在 ClinicalTrials.gov 上注册（NCT02995681）。
