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Effectiveness and safety of supervised home-based physical training in patients with COPD on long-term home oxygen therapy: a randomized trial
Kovelis D, Gomes ARS, Mazzarin C, Biazim SK, Pitta F, Valderramas S
Chest 2020 Mar 27:Epub ahead of print
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Patients with COPD in advanced stages who need long-term home oxygen therapy (LTHOT) have difficulty participating in outpatient pulmonary rehabilitation (PR) programs. This difficulty is due to the severity of their disease, limitations involving transportation and mobility, high costs, and issues related to patients' safety and individual needs. Unsupervised home-based physical training (PT) is frequently used. RESEARCH QUESTION: The main objective of this study was to investigate the effectiveness of a supervised home-based PT program on exercise capacity and other outcomes in patients with COPD receiving LTHOT. STUDY DESIGN AND METHODS: In a randomized clinical trial, patients with COPD who were on LTHOT were allocated into two groups: the supervised physical training (PT) group, consisting of patients who received home-based supervised muscle strength and endurance training in twice-weekly 60-min sessions for 12 weeks; and the unsupervised activity booklet group, consisting of patients who received a booklet advising them to perform exercise twice a week for 12 weeks. All participants were assessed prior to and following the intervention in terms of exercise capacity (6-min step-test and the 1-min sit-to-stand test); dyspnea (Medical Research Council scale); fatigue (Brazilian Portuguese version of the Fatigue Severity Scale); and health status (COPD Assessment Test). RESULTS: A total of 44 patients were assessed (mean age 70 +/- 8 years; FEV1 33 +/- 14% predicted) (PT group n = 22; booklet group n = 22). Only the PT group patients presented significant improvement in the 6-min step-test (21 +/- 9 versus 14 +/- 1; p = 0.001), Medical Research Council scale (3.3 +/- 1.0 versus 3.9 +/- 0.9; p = 0.013), Brazilian Portuguese version of the Fatigue Severity Scale (5.0 +/- 1.4 versus 5.2 +/- 1.3; p = 0.015), and COPD Assessment Test (21 +/- 8 versus 26 +/- 6; p = 0.001). No adverse effects were observed. INTERPRETATION: Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue, and health status in patients with COPD on LTHOT. CLINICAL TRIAL REGISTRATION: Brazilian Registry of Clinical Trials RBR-535smn.

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