REINFORCE: A randomized trial of resistance training in patients with radically treated respiratory cancer.

Abstract

7541 Background: Limited evidence suggest that patients (pts) with respiratory cancer improve their post-radical treatment (PRT) exercise capacity (EC) and quality of life (QoL) by rehabilitation (REH). Whole body vibration (WBV) is proposed as an alternative to conventional resistance training (CRT). REINFORCE investigates the effect of 2 supervised resistance training programs on functional and maximal EC and QoL, measured by resp. 6 minutes walking distance (6MWD), Wmax and EORTC-QLQ-C30 physical functioning (PF). Methods: Consecutive pts with cI-IIIB (N)SCLC or cI-II mesothelioma were evaluated before (M1) and after (M2) completion of either surgery (S) +/- platin-based chemotherapy (PCT) and postop. radiotherapy (RT) or RT +/- PCT, and then randomized to usual care (UC) or 38 sessions of either CRT or WBV. After stratification for COPD, S, PCT and center, 6MWD (primary endpoint), Wmax and PF were measured at M1, M2 and after 12 weeks (w) of REH (M3). Minimal clinical important difference in 6MWD is 54 m, in Wmax 10 Watt and in PF +9 points. Mean changes are compared within and in-between the intention-to-treat intervention groups using linear regression models. Results: 70 pts were randomized with balanced M1-characteristics: UC 24; CRT 24; WBV 22; male 73%, median age 62 y(29-79); median BMI 25 kg/m²(16-42); COPD 40%; NSCLC 91%; stage I-II 60%. 48% had S and 6% RT as sole therapy, 46% a combination of S or RT with PCT and/or PORT; pneumectomy in 19%. A median of 28 CRT-sessions (10 – 36) and 23 WBV-sessions (0 – 37) were attended with a median M2-M3 interval of 14 w (9-30). M2-M3 change in 6MWD is 95 m (58-132) in CRT (p<.0001), 37m (-1-76) in WBV (p =0.06), 1 m(-34-36) in UC and is significantly higher with CRT than with WBV (p value vs. UC 0.0006 and 0.16, resp.) and highest in CRT-pts without COPD (133 m (86-181), p< 0.0001). M3 values did not significantly exceed M1 with either intervention. M2-M3 change in Wmax significantly improved with 15 Watt (6-24) in both CRT and WBV(p= 0.002). M2-M3 PF increased 6 points (-1–14) in CRT (p= 0.1) and 8 points (0–16) in WBV (p=0.04). Conclusions: In pts with respiratory cancer, PRT REH is recommended, with CRT significantly improving functional and maximal EC and WBV increasing maximal EC and PF. Clinical trial information: NCT00752700.