Abstract
BACKGROUND: Although early ambulation (EA) is associated with improved outcomes in post-operative patients, implementation of EA in elderly patients is still a challenge. In this study, we aimed to design and assess a precision early ambulation program for cardiac rehabilitation. METHODS: We conducted a single-center, randomized and controlled clinical trial in elderly patients aged over 60 years after off-pump coronary artery bypass graft (OPCABG) surgery. Patients were randomly assigned to a precision early ambulation (PEA) group or a routine ambulation (Control) group. Age-predicted maximal heart rate (APMHR) and maximal oxygen uptake (VO(2max)) were used as a reference to formulate and monitor the PEA regimen. The primary end-point was the postoperative length of stay in hospital (PLOS). The secondary end-points included 90-day mortality, incidence of early discharge, laboratory tests, length of ICU stay, the incidence of multiple organ complications and post-traumatic stress disorder (PTSD). Ambulation outcomes were also recorded. RESULTS: In total, 178 patients were enrolled (n = 89 per group). In the intent-to-treat analysis, PLOS in the PEA group was shorter than that in the Control group (9.04 ± 3.08 versus 10.09 ± 3.32 days, respectively. Mean difference 1.045 days; 95% confidence interval [CI] 0.098-1.992; P = 0.031 in the unadjusted model; mean difference 0.957 days; CI 0.007-1.907; P = 0.048 in adjusted model). The incidence of early discharge differed significantly between the PEA and control groups (41[46.1%] versus 24[27.0%] patients, respectively. Odds ratio [OR] 0.432; CI 0.231-0.809; P = 0.009 in unadjusted model; OR 0.466; CI 0.244-0.889, P = 0.02 in adjusted model). The time of first bowel movement, partial pressure O(2) and post-traumatic stress disorder score in the PEA group were better than those in the Control group. Participants walked much longer distances on day 3 in the PEA group than those in the Control group (76.12 ± 29.02 versus 56.80 ± 24.40 m, respectively, P < 0.001). CONCLUSION: APMHR and VO(2max) are valuable for implementation of PEA according to an established security threshold. PEA after OPCAPG surgery is safe and reliable for elderly patients, not only reducing the hospital stay, but also improving their physiological and psychological symptoms. TRIAL REGISTRATION: This study is a component of a protocol retrospectively registered: Application of ERAS in cardiovascular surgery. TRIAL REGISTRATION NUMBER: ChiCTR1800018167 . Date of registration: 3rd September, 2018. URL of trial registry record: http://www.chictr.org.cn/index.aspx.