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

Author

Listed:
  • 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)

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.

Suggested Citation

  • Laura Bragonzoni & Giuseppe Barone & Francesco Benvenuti & Veronica Canal & Claudio Ripamonti & Sofia Marini & Laura Dallolio, 2020. "A Randomized Clinical Trial to Evaluate the Efficacy and Safety of the ACTLIFE Exercise Program for Women with Post-menopausal Osteoporosis: Study Protocol," IJERPH, MDPI, vol. 17(3), pages 1-10, January.
  • Handle: RePEc:gam:jijerp:v:17:y:2020:i:3:p:809-:d:313840
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    References listed on IDEAS

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    1. Sofia Marini & Erica Leoni & Alessandra Raggi & Tiziana Sanna & Nazzarena Malavolta & Buffa Angela & Pasqualino Maietta Latessa & Laura Dallolio, 2019. "Proposal of an Adapted Physical Activity Exercise Protocol for Women with Osteoporosis-Related Vertebral Fractures: A Pilot Study to Evaluate Feasibility, Safety, and Effectiveness," IJERPH, MDPI, vol. 16(14), pages 1-15, July.
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    Cited by:

    1. Erika Pinelli & Giuseppe Barone & Sofia Marini & Francesco Benvenuti & Marie H. Murphy & Mikko Julin & Wolfgang Kemmler & Simon Von Stengel & Stefano Di Paolo & Laura Dallolio & Pasqualino Maietta Lat, 2021. "Effects of COVID-19 Lockdown on Adherence to Individual Home- or Gym-Based Exercise Training among Women with Postmenopausal Osteoporosis," IJERPH, MDPI, vol. 18(5), pages 1-8, March.

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    1. Erika Pinelli & Giuseppe Barone & Sofia Marini & Francesco Benvenuti & Marie H. Murphy & Mikko Julin & Wolfgang Kemmler & Simon Von Stengel & Stefano Di Paolo & Laura Dallolio & Pasqualino Maietta Lat, 2021. "Effects of COVID-19 Lockdown on Adherence to Individual Home- or Gym-Based Exercise Training among Women with Postmenopausal Osteoporosis," IJERPH, MDPI, vol. 18(5), pages 1-8, March.

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