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Standardized exercise training is feasible, safe, and effective in pulmonary arterial and chronic thromboembolic pulmonary hypertension: results from a large European multicentre randomized controlled trial
Grunig E, MacKenzie A, Peacock AJ, Eichstaedt CA, Benjamin N, Nechwatal R, Ulrich S, Saxer S, Bussotti M, Sommaruga M, Ghio S, Gumbiene L, Paleviciute E, Jureviciene E, Cittadini A, Stanziola AA, Marra AM, Kovacs G, Olschewski H, Barbera JA, Blanco I, Spruit MA, Franssen FME, Vonk Noordegraaf A, Reis A, Santos M, Viamonte SG, Demeyer H, Delcroix M, Bossone E, Johnson M
European Heart Journal 2021 Jun 14;42(23):2284-2295
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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*

AIMS: This prospective, randomized, controlled, multicentre study aimed to evaluate efficacy and safety of exercise training in patients with pulmonary arterial (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). METHODS AND RESULTS: For the first time a specialized PAH/CTEPH rehabilitation programme was implemented in 11 centres across 10 European countries. Out of 129 enrolled patients, 116 patients (58 versus 58 randomized into a training or usual care control group) on disease-targeted medication completed the study (85 female; mean age 53.6 +/- 12.5 years; mean pulmonary arterial pressure 46.6 +/- 15.1 mmHg; World Health Organization (WHO) functional class II 53%, III 46%; PAH n = 98; CTEPH n = 18). Patients of the training group performed a standardized in-hospital rehabilitation with mean duration of 25 days (95% confidence interval (CI) 17 to 33 days), which was continued at home. The primary endpoint, change of 6-min walking distance, significantly improved by 34.1 +/- 8.3 m in the training compared with the control group (95% CI 18 to 51 m; p < 0.0001). Exercise training was feasible, safe, and well-tolerated. Secondary endpoints showed improvements in quality of life (Short-Form Health Survey 36 Mental Health 7.3 +/- 2.5, p = 0.004), WHO-functional class (training versus control improvement 9:1, worsening 4:3; Chi2 p = 0.027) and peak oxygen consumption (0.9 +/- 0.5 mL/min/kg, p = 0.048) compared with the control group. CONCLUSION: This is the first multicentre and so far the largest randomized, controlled study on feasibility, safety, and efficacy of exercise training as add-on to medical therapy in PAH and CTEPH. Within this study, a standardized specialized training programme with in-hospital start was successfully established in 10 European countries.
For more information on this journal, please visit http://www.harcourt-international.com/journals/EUHJ.

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