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

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.

The Effect of Physical Activity on Bone Biomarkers in People With Osteoporosis: A Systematic Review

“…In addition, exercise can help to achieve beneficial and significant effects on quality of life, balance, and functional mobility also in patients with osteoporosis-related vertebral fractures (43,44). However, there is still no agreement on which type of exercise, in terms of intensity, frequency, duration, type and setting, is optimal and can affect bone metabolism in people with osteoporosis (45)(46)(47).…”

Effects of COVID-19 Lockdown on Adherence to Individual Home- or Gym-Based Exercise Training among Women with Postmenopausal Osteoporosis

“…Details on study methods have been published previously [ 21 ]. Briefly, postmenopausal women with OP were recruited by the Centro Osteoporosi e Malattie Metaboliche dello Scheletro of Rizzoli Orthopaedic Institute of Bologna, Italy, and had no significant comorbidities affecting motor or cognitive functions.…”

“…Subsequently, the trainer contacted the IHT participants at pre-established time intervals to encourage them to exercise regularly and to obtain information on their health status. Every 6–8 weeks, a face-to-face appointment was scheduled to review and upgrade the exercise program [ 21 ], based on the progression principle.…”

“…Thus, our study was originally designed to consider whether IHT could be a valid alternative to GGT, since it could overcome problems related to accessibility to gyms or time schedule rigidity. With these premises, within the European project ACTLIFE, we started a randomized trial [ 21 ] to verify the efficacy of a physical activity program designed to improve the quality of life in sedentary women with postmenopausal OP, when administered IHT or GGT. During the trial, the COVID-19 pandemic resulted in a government-imposed national lockdown from 9 March–May 18 2020, restricting the movement of the population except for necessity, work, and health circumstances.…”

Osteoporosis and the Potential of Cell-Based Therapeutic Strategies

“…A healthy and active lifestyle is vital for the proper maintenance of all body tissues, including bone. Several studies have highlighted the importance of physical exercise to improve the quality of life of patients with osteoporosis [92][93][94]. Recently, Filipović, T. et al 2020 [95], has demonstrated that exercising is able to modulate the enzymatic activity of serum matrix metalloproteinase-9 (MMP-9) and tissue inhibitor of metalloproteinase 1 (TIMP-1) in postmenopausal osteoporotic patients.…”