Randomized Controlled Trial of a Virtually Delivered Exercise and Stress Management Program to Improve Physical Performance of Hematopoietic Cell Transplant Survivors.

Abstract

Because of advances in hematopoietic cell transplant (HCT), meeting the long-term health needs of increasing numbers of HCT survivors remains challenging. This multicenter trial aimed to assess the short- and long-term effects of an exercise and mindfulness intervention delivered by telehealth. One hundred thirty-nine participants >6 months post-HCT were randomly assigned 1:1 to a 6-week personalized exercise and mindfulness training with three motivation sessions at 3-6 months via an online meeting platform or usual care. Physical and quality-of-life (QOL) assessments were conducted online for 12 months. The primary end point was the 6-minute walk test (6-MWT) at 3 months. The median time post-HCT was 21 months (range, 7-67 months). Improvement in mean difference of 6-MWT was found in the intervention group compared with control (intention-to-treat) at 3 months (51.4 m [95% CI, 27.3 to 75.5]; <i>P</i> < .001; effect size [ES], 0.52) and was maintained at 12 months (59.3 m, <i>P</i> = .003; ES, 0.60). Sustained improvements in mean difference for sit-to-stand (STS) at 3 and 12 months were seen. There were no significant changes in hand grip strength or QOL outcomes between groups. A significant difference in serum soluble intercellular adhesion molecule-1 (sICAM-1) concentration was observed between the intervention and control groups in the exploratory study. No intervention adverse events were found. The supervised multimodal telehealth intervention provided clinically meaningful and durable improvement of physical capacity in HCT survivors. This home-based program has the potential to provide an unmet need for HCT survivors. Similar programs may benefit survivors of other cancers, organ transplants, and chronic disorders.