Effects of a Partially Supervised Conditioning Program in Cystic Fibrosis: An International Multicenter, Randomized Controlled Trial (ACTIVATE-CF)

Abstract

Rationale The long-term effects of vigorous physical activity (PA) on lung function in cystic fibrosis are unclear. Objectives To evaluate effects of a 12-month partially supervised PA intervention using motivational feedback. Methods In a parallel-arm multicenter randomized controlled trial (ACTIVATE-CF), relatively inactive patients aged at least 12 years were randomly assigned (1:1 ratio) to an intervention group or control group. The intervention group consented to add 3 hours of vigorous PA per week, whereas the control group was asked not to change their PA behavior. Primary endpoint was change in percent predicted FEV 1 (ΔFEV 1 ) at 6 months. Secondary endpoints included PA, exercise capacity, exercise motives, time to first exacerbation and exacerbation rates, quality of life, anxiety, depression, stress, and blood glucose control. Data were analyzed using mixed linear models. Measurements and Main Results A total of 117 patients (40% of target sample size) were randomized to an intervention (n = 60) or control group (n = 57). After 6 months, ΔFEV 1 was significantly higher in the control group compared with the intervention group (2.70% predicted [95% confidence interval, 0.13–5.26]; P = 0.04). The intervention group reported increased vigorous PA compared with the control group at each study visit, had higher exercise capacity at 6 and 12 months, and higher PA at 12 months. No effects were seen in other secondary outcomes. Conclusions ACTIVATE-CF increased vigorous PA and exercise capacity, with effects carried over for the subsequent 6 months, but resulted in better FEV 1 in the control group.

Effects of Exercise on Nutritional Status in People with Cystic Fibrosis: A Systematic Review

“…Weight, BMI, and fat-free mass were improved in both children and adults; in addition, the number of adults classified as “malnourished” decreased from 41% to 24%, but was unchanged (24%) in children. To our knowledge, the largest exercise-related CF study was recently completed and published [ 29 ]. The ACTIVATE-CF study randomized 117 children (≥12 years old) and adults to a 12 month partially supervised vigorous physical activity intervention [ 29 ]; although data on body composition were collected as a secondary outcome [ 30 ], these data are not yet reported.…”

Disconcerting and Counterintuitive Findings from a Trial of Exercise in Cystic Fibrosis: Can Exercise Make Our Patients Worse?

“…This despite the fact that the intervention group reported more vigorous physical activity levels and had a higher exercise capacity ( o 2 peak) at 6 and 12 months. There were no differences between the two groups in the time to first exacerbation or number of exacerbations or hospitalizations ( 4 ).…”

“…In this issue of the Journal , the authors of the ACTIVATE-CF trial (pp. 330–339 ) ( 4 ) have endeavored to provide such evidence. We applaud the authors for investigating such an important component of CF care and successfully implementing this complex intervention.…”

“…The intervention group was asked to add at least 3 hours of vigorous physical activity per week (including 30 minutes of strength-building exercises and 2 hours of aerobic activity), whereas the control group was asked to continue their current activity level. The intervention group also received structured motivational interviews, exercise intensity prescriptions, activity counseling, and monitoring of their training ( 4 ).…”

“…Perhaps in light of the improved health of patients with CF, and more patients maintaining their FEV 1 in the normal range, FEV 1 may no longer be the most appropriate primary endpoint for many studies ( 8 , 9 ). And although there is evidence showing that exercise can improve lung function in CF at 6 months ( 4 ), and it has been used as a substitute for chest physiotherapy ( 10 ), is there a good physiologic reason to think it will increase FEV 1 ? Given the significance of o 2 peak as a prognostic factor for survival in CF ( 11 , 12 ), cardiopulmonary exercise testing might be a better choice of outcome for studies examining the effects of exercise and exercise programs.…”