2005 OPEN FORUM Abstracts
Improvement in Self-Reported Exercise Participation with the Combination of Tiotropium and Rehabilitative Exercise Training in COPD Patients
Steven Kesten, MD1; Richard Casaburi, MD2; David Kukafka, MD3; Christopher B. Cooper, MD4 1Boehringer Ingelheim, Ridgefield, CT, 2Harbor-UCLA Med Center, Torrance, CA; 3North Colorado Pulmonary Consultants PC, Fort Collins, CO; 4UCLA School of Medicine, Los Angeles, CA.
Background: We have previously demonstrated that improvements in ventilatory mechanics during treatment with tiotropium augments the exercise tolerance benefits observed during pulmonary rehabilitation (PR) (Casaburi et al. Chest 2004). We wondered whether patients also were able to increase their physical activities outside of the PR program.
Methods: COPD patients participating in 8 weeks of PR (treadmill training 3/week; ³30 minutes/session) were studied in a randomized, double-blind, placebo-controlled trial of tiotropium 18 µg once daily (tiotropium=47, placebo=44). Study drug was administered for 5 weeks prior to, 8 weeks during and 12 weeks following PR. The primary endpoint was endurance time (ET) during treadmill walking (0% incline; 80% of maximum speed attained at an initial incremental test). As part of the protocol, all patients were requested to complete an activity questionnaire that captured participation in pre-defined activities (i.e. walking, stairs, cycling, swimming, treadmill, other), the frequency of activity and the mean duration of participation during the two weeks prior to each visit. The overall mean time participating in such activities was calculated as the product of the number of sessions in an activity and the duration of participation. The time for each activity was summed and divided by the number of patients submitting an activity form at a minimum of weeks 4 and 25 to ascertain mean participation per patient.
Results: Mean age=67 years; 57% male; FEV1=0.88 L (34% predicted); baseline ET=9.72 min. Tiotropium amplified the effectiveness of PR as discerned from the mean increase in ET from week 4 to week 13 (80% with tiotropium group, 57% with placebo group). In the follow-up period, the improvements were maintained in the tiotropium group and began to decline in the placebo group. On an individual clinic visit day, only 36 to 57 patients completed the activity outside of PR questionnaire. The fraction of completers was similar in the two subject groups. Of the patients completing questionnaires, the mean (SE) duration of participation (minutes during 2 weeks prior to each visit) and difference from week 4 (prior to PR) are as follows:
|N||Time (min)||Δ Week 4 (min)||N||Time (min)||Δ Week 4 (min)|
|Prior to PR (week 4)||29||255 (38)||-||28||250 (45)||-|
|During PR (week 8)||25||322 (39)||43 (53)||17||349 (74)||110 (85)|
|End of PR (week 13)||22||526 (75)||269 (63)||16||355 (102)||99 (106)|
|Follow-up (week 21)||19||432 (59)||159 (58)||17||394 (97)||125 (108)|
|Follow-up (week 25)||22||562 (86)||262 (96)||16||346 (95)||60 (93)|
Conclusions: Tiotropium amplifies the effectiveness of PR as seen by increases in patient self-reported participation in physical activities outside of PR. This observation corroborates the significant improvements in treadmill endurance time with tiotropium relative to the control group documented in the PR program; however, definitive conclusions are limited as not all patients submitted the activity form.
Funded by Boehringer Ingelheim and Pfizer.