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

Document Type : PROTOCOL

Authors

1 Physical Therapy Department, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran

2 Department of Rheumatology, Zanjan University of Medical Sciences, Zanjan, Iran

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. 
Level of evidence: Not applicable

Keywords

Main Subjects

References

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The Archives of Bone and Joint Surgery
Volume 12, Issue 7
July 2024
Pages 522-530

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History

  • Receive Date: 24 December 2023
  • Revise Date: 01 May 2024
  • Accept Date: 07 April 2024

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