A Randomized Clinical Trial to Evaluate the Efficacy and Safety of the ACTLIFE Exercise Program for Women with Post-menopausal Osteoporosis: Study Protocol

Laura Bragonzoni, Giuseppe Barone, Francesco Benvenuti, Veronica Canal, Claudio Ripamonti, Sofia Marini and Laura Dallolio
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Laura Bragonzoni: Department of Life Quality Studies, University of Bologna; Campus Rimini, Corso d’Augusto, 237, 47921 Rimini, Italy
Giuseppe Barone: Department of Life Quality Studies, University of Bologna; Campus Rimini, Corso d’Augusto, 237, 47921 Rimini, Italy
Francesco Benvenuti: Department of Life Quality Studies, University of Bologna; Campus Rimini, Corso d’Augusto, 237, 47921 Rimini, Italy
Veronica Canal: Unit of Hygiene, Public Health and Medical Statistics, Department of Biomedical and Neuromotor Science, University of Bologna, Via San Giacomo, 12, 40138 Bologna, Italy
Claudio Ripamonti: Center for Osteoporosis and Bone Metabolic Disease, Rizzoli Orthopaedic Institute, Via G.C. Pupilli,1, 40136 Bologna, Italy
Sofia Marini: Department of Life Quality Studies, University of Bologna; Campus Rimini, Corso d’Augusto, 237, 47921 Rimini, Italy
Laura Dallolio: Unit of Hygiene, Public Health and Medical Statistics, Department of Biomedical and Neuromotor Science, University of Bologna, Via San Giacomo, 12, 40138 Bologna, Italy

IJERPH, 2020, vol. 17, issue 3, 1-10

Abstract: Osteoporosis (OP) is a systemic disease of the skeleton characterized by increased risk of fracture. There is a general consensus on the efficacy of physical activity in the prevention of bone loss, falls and fractures, but there is no agreement on the best setting to exercise. The aim of the study is to evaluate the efficacy of a 12-months exercise protocol for women with post-menopausal OP when administered as individual home training (IHT) versus gym group training (GGT). The study is a randomized trial with two parallel groups. Sedentary patients with primary post-menopausal osteoporosis are recruited at the Istituto Ortopedico Rizzoli of Bologna. In the first group, the 12-month ACTLIFE program is performed as IHT, while in the second as GGT. The program is aimed at improving joint mobility, muscle force, balance, motor coordination and endurance. The study is single blinded. Patients are assessed at baseline and after 6 and 12 months. The primary outcome is the modification of quality of life measured with the Short Osteoporosis Quality of Life Questionnaire (ECOS-16). The findings of this study will highlight advantages and disadvantages of exercising in the two different settings and provide evidence on how to increase physical activity in osteoporotic women.

Keywords: post-menopausal osteoporosis; physical activity; quality of life; exercise; gym training; home training (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2020
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (1)

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