Comparing the Effect of Bone-loading Exercises and Pulsed Electromagnetic Fields on Bone Turnover Markers in Women with Osteoporosis: A Randomized Clinical Trial Study Protocol.

Abstract

Objective: Given the bone sensitivity to mechanical stimulus, bone-loading exercises and applying the Pulsed Electromagnetic Fields (PEMF(s)) are recommended for promoting bone strength. In this context, these two interventions 's effect on bone turnover markers (BTMs) in osteoporosis patients is yet to be clarified; consequently, an attempt is made in this study to compare the effect of these two interventions on bone turnover markers in women with Postmenopausal Osteoporosis (PMOP).

Methods: This study is design as a randomized, single-center, three-arms, controlled trial. A total of 51 women with PMOP will be randomly assigned to three groups of 17, using opaque, sealed envelopes containing labels for A, B, and C groups. Group A) will receive bone-loading exercises, B) will follow the PEMF(s) and C) will be exposed to the combination of A and B. These three groups will require intervention for 24 sessions (2 sessions/week) next to their routine medical treatment (Alendronate+ Calcium+ Vitamin D). The primary outcome of this study is the serum biomarker of bone formation (bone-specific alkaline phosphatase, BSALP) and resorption (N-terminal telopeptide, NTX). The secondary outcomes consist of thoracic kyphosis angle, fear of falling, and quality of life. The outcomes are measured three times: at baseline, after 24 sessions of intervention, and at 12 weeks follow-up. A primary outcome will be measured and reported by a laboratory expert who is blinded to the participant grouping.

Result: The trial has the code of ethics for research (IR.TUMS.FNM.REC.1401.126) and the code of Iranian Registry of Clinical Trials (IRCT) (IRCT20221202056687N1). Study results are expected to be available by mid-2024.

Conclusion: This trial will provide new practical knowledge on the bone-loading exercises and PEMFS(s)'s effect on PMOP women. This knowledge is of the essence for physiotherapists, clinicians, other healthcare professionals, and policymakers in the healthcare system.