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Comparison of lung volume reduction surgery and physical training on health status and physiologic outcomes: a randomized controlled clinical trial
Hillerdal G, Lofdahl CG, Strom K, Skoogh BE, Jorfeldt L, Nilsson F, Forslund-Stiby D, Ranstam J, Gyllstedt E
Chest 2005 Nov;128(5):3489-3499
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY OBJECTIVES: In 1996, researchers in Sweden initiated a collaborative randomized study comparing lung volume reduction surgery (LVRS) and physical training with physical training alone. The primary end point was health status; secondary end points included survival and physiologic measurements. DESIGN: After an initial 6-week physical training program, researchers' patients were randomized to either LVRS (surgical group (SG)) with continued training for 3 months, or to continued training alone (training group (TG)) for 1 year. SETTING: All seven thoracic surgery centers in Sweden. PATIENTS: All patients in Sweden with severe emphysema fulfilling inclusion criteria for LVRS. INTERVENTIONS: Patients randomized to surgery underwent a median sternotomy, except for a few patients in whom thoracotomy or video-assisted thoracoscopy were performed. In the TG, supervised physical training continued for 1 year; in the SG, supervised physical training continued for 3 months postoperatively. MEASUREMENTS AND RESULTS: Fifty-three patients were included in each group. Six in-hospital deaths occurred after surgery (12%), and one more death occurred during follow-up. Two deaths occurred in the TG. The difference in death rates between the groups was not statistically significant. Health status, as measured by St George Respiratory Questionnaire (SGRQ) (total scale score mean difference at 1 year, 14.7; 95% confidence interval (CI) 9.8 to 19.7) as well as by the Medical Outcomes Study Short-Form General Health Survey (physical function scale score mean difference at 1 year, 19.7; 95% CI 12.1 to 27.3) was improved from baseline in the SG compared with the TG. FEV1, residual volume, and shuttle walking test values also improved in the SG but not in the TG after 6 months and 12 months. CONCLUSIONS: In severe emphysema, LVRS can improve health status in survivors but is associated with mortality risk. The effects are stable for at least 1 year. Physical training alone failed to achieve a similar improvement.

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