SUBMITTED 12 OCT 2022 1 REVISION REQ. 13 DEC 22; REVISION RECD. 15 JAN 23 2 ACCEPTED 8 FEB 23 3 ONLINE-FIRST: FEBRUARY 2023 4 DOI: https://doi.org/10.18295/squmj.1.2023.010 5 6 Effect of Life-Style Modification Intervention Programme on Bone Mineral 7 Density among Postmenopausal Women with Osteoporosis 8 Anupama D.S,1 *Judith A. Noronha,1 Kiran K.V. Acharya,2 Mukhyaprana 9 Prabhu,3 Ravishankar N,4 Baby S. Nayak5 10 11 5Department of Child Health Nursing, 1Manipal College of Nursing, Manipal Academy of 12 Higher Education, Manipal, India; Departments of 3Medicine and 2Orthopedics, Kasturba 13 Medical College, Manipal, India; 4Department of Biostatistics, Vallabhai Patel Chest 14 Institute, University of Delhi, Delhi, India. 15 *Corresponding Author’s e-mail: judith.n@manipal.edu 16 17 Abstract 18 Objectives: Osteoporosis is one of the major public health problems worldwide among 19 postmenopausal osteoporotic women. Lifestyle modification interventions along with 20 pharmacotherapy helps to revert the bone loss and prevent the complications. Methods: A 21 randomized controlled trial was conducted at Kasturba Hospital, Manipal from January 2019 22 to December 2021 among postmenopausal women with osteoporosis. The postmenopausal 23 women who attended the osteoporosis clinic and were within the age group of 45-65 years, 24 could speak and understand English or Kannada, and whose Bone Mineral Density (BMD) 25 score was between -1 and -3 were included for the study. The total sample size of the study 26 was 120 with 60 in each of the experimental and control group. After obtaining the informed 27 consent, stratified block randomization method was used to allocate the participants to 28 intervention and control group. The BMD was monitored by the portable ultrasound 29 densitometer by a technician at the outpatient departments. The baseline information was 30 collected by a structured demographic questionnaire. Intervention group participants received 31 Lifestyle Modification Intervention Program (LMIP) whereas control group received the 32 standard regular care by the physician. Follow up was done at three and six months. Results: 33 The results revealed that the increase in the BMD median score among the experimental 34 group was from -2.2 [(-2.5, -1.8)] to -1.5 [(-1.8, -0.65)] where as in the control group it was 35 from -2.3 [(-2.6, -1.9)] to -2.0 [(-2.4, -1.5)]. The increase in the median score of the 36 experimental group (0.7) was higher than in the control group (0.3). The results of Mann 37 Whitey U test showed a statistical significance between the intervention and control groups in 38 the post test after 6 months (U =.505.5, p<0.05). Wilcoxon signed rank test showed the 39 significant change in both the intervention and control groups from pre-test to post-test I (3 40 months) and Post-test II (6 months) (p<0.001). Conclusion: The lifestyle modification 41 intervention was found to be effective in improving the bone health status of postmenopausal 42 women. Hence it is very important to integrate in regular therapy. 43 Keywords: LMIP, postmenopausal women, bone health status, bone mineral density 44 45 Advances in Knowledge 46  Effective lifestyle modification intervention was efficient in improving the 47 Bone Mineral Density of Postmenopausal women with osteoporosis 48  The constant encouragement and motivation endure lifestyle modification 49  Counselling and education are imperative to improve the bone health status of 50 the postmenopausal women 51 Application to Patient Care 52  Integrating lifestyle modification interventions with pharmacological 53 treatment would aid postmenopausal osteoporotic women in reversing bone 54 loss and speeding recovery. 55  The distribution of informational, educational, and communication materials, 56 as well as organized counselling services to postmenopausal osteoporotic 57 women, would be beneficial for the self-management of osteoporosis. 58 59 Introduction 60 Osteoporosis is a widespread illness that causes a systemic loss of bone mass and 61 microarchitecture, resulting in fragility fractures. 1 Osteoporosis is more commonly seen in 62 older adults and women. 2 With an older population and an improvement in life expectancy, 63 osteoporosis is becoming a worldwide epidemic. According to estimates, more than 200 64 million individuals worldwide have osteoporosis3, and one in three women over 50 and one in 65 five men may experience osteoporotic fractures at some point in their lifetime4. These fractures, 66 which primarily occur at the hip, vertebrae, and distal forearm 5 are associated with significant 67 morbidity, mortality, and reduced quality of life, which can be attributed not only to the fracture 68 itself but also to the high prevalence of comorbidities.6 69 70 Osteoporosis is diagnosed by measuring BMD of the hip and spine with dual energy X-ray 71 absorptiometry.7 BMD can be assessed using quantitative computed tomography, but it is 72 limited by radiation exposure and cost. Quantitative calcaneal ultrasonography and peripheral 73 DEXA, which measure BMD in the heel, finger, and forearm and can effectively predict 74 fracture risk, are much more portable and less expensive than central DEXA. 8 The World 75 Health Organization defines osteoporosis as a BMD that is 2.5 standard deviations or more 76 below the average for young healthy women.6 77 78 Since oestrogen is essential for maintaining bone health, postmenopausal women have a higher 79 prevalence of osteoporosis and associated fractures than older men. A 60-year-old woman has 80 an approximately 44% lifetime risk of fracture, which is nearly double the 25% risk for a man 81 of the same age.9. The prevention and treatment of postmenopausal osteoporosis may involve 82 a variety of non-pharmacologic approaches.10 Certain osteoporosis risk factors in 83 postmenopausal women can be reversed by modifying one's lifestyle, for instance through 84 exercise, smoking cessation, and reducing consumption of caffeine and alcohol. Regular 85 weight-bearing activity and a balanced diet with appropriate calcium and vitamin D 86 consumption are the main two lifestyle changes that can reduce the risk of fracture in 87 postmenopausal women. Other modifiable lifestyle variables important for bone health and 88 lowering fracture risk include not smoking, weight management, reduced alcohol intake, and 89 precautions for potential falls at home.11,12 For people with osteoporosis who are at risk for 90 falls and fractures, improving lighting at home, removing obstacles from the home that can 91 cause falls, and using undergarments with hip protectors are advised. Resistance training and 92 weight-bearing exercises are suggested for postmenopausal women because they help to 93 maintain BMD13 Although lifestyle changes alone may not be sufficient to prevent bone loss 94 or reduce fracture risk, particularly in high-risk groups, they do provide an important 95 foundation along with pharmacologic approaches to prevent or treat osteoporosis.14 Therefore, 96 it is very important to incorporate the lifestyle modification interventions in the mild stage of 97 osteoporosis and osteopenia so that further complications can be prevented. 15 98 99 Health care providers play a crucial role in the management of osteoporosis with regard to the 100 exercise training and client education in maintaining the bone density. Exercise programmes 101 have been found to be effective in improving the bone mineral density of postmenopausal 102 women. 16Also, knowledge and belief changes in osteoporotic women can be facilitated by 103 brief written educational materials. 17A successful home rehabilitation programme typically 104 depends on maintaining a regular exercise schedule, which is strongly influenced by self-105 motivation and other extrinsic factors18 In addition, it is well known that non-adherence to 106 pharmacological treatment in osteoporosis is a concern19 and there is evidence that a group-107 based educational programme and multicomponent approach interventions 20would improve 108 patients' adherence with medical treatment. However, the studies that focus on comprehensive 109 lifestyle modification interventions along with patient education were not available in the 110 Indian context. We therefore hypothesise that taking part in a lifestyle modification 111 intervention programme will increase the bone mineral density of postmenopausal women with 112 osteoporosis in light of the literature that is currently available. 113 114 Methods 115 This randomized control trial was conducted at the osteoporosis clinic of the outpatient 116 department of the Kasturba Hospital, Manipal from January 2019 to December 2021. 117 118 This trial was registered under the Clinical Trial Registry of India (CTRI) with Trial no. 119 CTRI/2019/05/019045 and ethical permission was obtained from Institutional Ethics 120 Committee, Kasturba Hospital and Kasturba Medical College, Manipal 121 122 Inclusion criteria were postmenopausal women who attended the osteoporosis clinic and were 123 within the age group of 45-65 years, could speak and understand English or Kannada, and 124 whose BMD score was between -1 and -3. Postmenopausal osteoporotic patients who had a 125 history of fracture and were admitted to the hospital were excluded from the study. 126 127 Sample size was calculated using the formula for two independent groups. 128 2[Z1-α/2 + Z1- β/2] 2 σ2 129 n= ------------------------------------------- 130 d2 131 Where 132 Z1-α/2 is1.96 at a 95 % confidence interval. 133 Z1- β/2 is 0.84 at the power of 80% 134 σ is the standard deviation (56.78) 135 d is the clinically significant difference (40.68) 136 Considering the 30% attrition rate, a total sample size of 120 was calculated, i.e. 60 each in of 137 the intervention and control group was included (standard deviation and clinically significant 138 difference were computed based on the pilot study findings). 139 140 Data collection was done after obtaining written informed consent. A stratified block 141 randomization method was used to allocate the sample. Strata were developed based on the age 142 groups, i.e., 45-55 years and 56-65 years, and there were 12 total blocks, with 10 samples in 143 each block. Random numbers were created using a computer. The allocation concealment was 144 done by using Sequentially Numbered Opaque Sealed Envelopes (SNOSE), and it was 145 prepared by an external member who was not directly involved in the study. 146 147 Bone mineral density was measured by portable ultrasound bone densitometer (Sunlight Mini 148 Omni Bone Sonometer with frequency of 1.25MHz) at the wrist region by a technician at the 149 outpatient departments. The baseline information was collected by a structured demographic 150 questionnaire. Intervention group participants received the Lifestyle Modification Intervention 151 Programme (LMIP). The detailed process of RCT is given in Figure 1. 152 153 The LMIP was based on three pillars: physical activity, health education (behavioural change 154 communication) on exercise, diet, and follow-up, and motivation for sustenance. It included 155 the components of exercise teaching, self- learning of exercises through videos, a brochure on 156 osteoporosis management, and motivational videos on management of osteoporosis, reminder 157 messages and regular phone calls as a follow up and motivation to adhere to the lifestyle 158 modification intervention. The LMIP was developed by adopting a meticulous program 159 development approach including an extensive review of literature, designing of the program, 160 experts’ advice, validation of the program and piloting of the program. The exercises included 161 in LMIP were stretching exercises, wall pushups, toe lifts, sitting on a chair and getting up, and 162 stepping up and down. The researcher taught these exercises to each participant individually in 163 the outpatient department. The same exercises video prepared by the researcher was sent to the 164 postmenopausal women's mobile phones. In addition, health education on osteoporosis and its 165 management was provided. The participants were also given a brochure on postmenopausal 166 osteoporosis management, which comprised a brief explanation of the disease condition, signs 167 and symptoms, diagnosis, follow-up, exercise, and dietary management. Researchers used 168 mobile phones to deliver weekly texts and fortnightly calls, as well as motivational videos, to 169 emphasize the consistency of LMIP. 170 Follow ups for BMD were carried out at three and six months. However, there were dropouts 171 for follow ups due to COVID-19 and lockdown. 172 173 The control group received the standard pharmacological treatment by the physician as per the 174 hospital protocol. They were allowed to perform their daily activities without any restriction 175 up to the end of the study (6 months). After which, the control group participants were provided 176 with the same LMIP that was received by the experimental group. 177 178 Statistical analysis 179 The data were coded and analysed using SPSS 22. Descriptive and inferential statistical tests 180 were used for the analysis. Homogeneity among the intervention and control groups at baseline 181 was tested using chi square test. If the frequency cells were less than five, then Fisher's exact 182 test was considered. The Shapiro-Wilk test was used to determine normal distributions. As the 183 data was not normally distributed, non –parametric tests were used for statistical analysis. 184 Differences between groups were analysed using the Mann–Whitney U test. The Wilcoxon 185 signed-rank test was used to analyse the change in BMD at baseline and at 3 and 6 months. p 186 value of less than 0.05 was considered significant. 187 188 Results 189 Demographic characteristics 190 In this randomized control trial, 120 postmenopausal osteoporotic women were enrolled, with 191 60 in each of the intervention and control groups. During the follow up after six months, 18 192 sample from the intervention group and 15 from the control group were dropped out due to the 193 COVID-19 pandemic and lockdown. The mean age of the intervention and control group were 194 56.8 (SD=2.5) and 55.7 (SD=1.8) respectively. Higher proportions of the women were 195 housewives (70.83%). It was also found that 42.5% of the participants had two children and 196 58.33% had four or fewer family members (Table 1). Homogeneity test results showed that 197 both the intervention and control groups were homogenous (p>0.05) 198 199 Effectiveness of lifestyle modification intervention on bone mineral density 200 As the data was not normally distributed, Mann-Whitney U test was used to compare the 201 differences in the median pre-test and post-test scores between the experimental and control 202 groups among postmenopausal osteoporotic women (Table 2). The Wilcoxon Signed Rank test 203 was used to compare the change in scores from pre-test to post-test II (Table 3). 204 The increase in the BMD median score among the experimental group was from -2.2 [(-2.5, -205 1.8)] to -1.5 [(-1.8, -0.65)] where as in the control group it was from -2.3 [(-2.6, -1.9)] to -2.0 206 [(-2.4, -1.5)]. The increase in the median score of the experimental group (0.7) was higher than 207 in the control group (0.3). The results of Mann Whitey U test showed a statistical significance 208 between the intervention and control groups in the post test II (U =.505.5, p<0.05). 209 210 A Wilcoxon signed rank test was computed to observe the change in BMD scores within 211 intervention and control groups from pre-test to post-test I and II. The findings revealed 212 significant change in both the intervention and control groups from pre-test to post-test I and 213 post-test II (p<0.001). Hence, it can be concluded that LMIP was very effective in increasing 214 the bone mineral density among the postmenopausal women with osteoporosis. 215 216 Discussion 217 We aimed to investigate the effectiveness of LMIP on the BMD of postmenopausal 218 osteoporotic women. In our study, lifestyle modification interventions were provided along 219 with the pharmacological treatment for the intervention group. Our results demonstrated that 220 the LMIP improved the BMD of the postmenopausal osteoporotic women in comparison to the 221 control group, which received only pharmacological treatment. This may be explained by the 222 fact that the integration of lifestyle modification components along with pharmacological 223 treatment, including exercise, regular physical activities, dietary management, reinforcement 224 of treatment, and follow-up, may have influenced the improvement of the BMD. It is significant 225 that the LMIP was deemed safe because, over the course of the study, no injury incidences 226 were reported. Additionally, regular phone calls for follow-up monitoring may have 227 encouraged participants to accomplish the activities. The health education provided by the 228 researcher motivated them to adhere to the therapy positively and have great enthusiasm for 229 performing the activities. 230 231 Our study finding is consistent with a study that had 8-week physiotherapeutic education on 232 back extensor muscle (BEM) strength, physical performance, balance, and QOL in 233 postmenopausal women21. In addition, our findings are similar with a study where osteoporotic 234 women underwent a 6-month personalized drug therapy and focused mechanoacoustic 235 vibration which had a beneficial effect on BMD22. Another study also reported a significant 236 increase in the bone mineral density of the participants after an intervention programme which 237 included physical activity and diet supplementation23. Similarly, many other studies conducted 238 on the effect of different exercises on bone mineral density found them to be effective.24,25 239 There is evidence that increasing physical exercise improves bone mineral density.26 240 Furthermore, there were independent studies and reviews on the impact of dietary management 241 on risk reduction and a better prognosis for osteoporosis.27 28 29 In addition, there was a study 242 which evaluated the impact of osteoporosis education on osteoporosis knowledge and calcium 243 intake.30 There were few systematic reviews conducted on the impact of exercises on bone 244 mineral density. As per the results of the systematic review, exercise could be a safe and 245 effective strategy to prevent bone loss in postmenopausal women. 31 246 247 There was a dearth of studies to compare the integration of lifestyle modification interventions 248 with pharmacological treatment, including exercise, dietary management, reinforcement of 249 treatment, and follow-up. Furthermore, reinforcement and motivation were integrated into the 250 study through periodic phone calls and messages. Individual counselling and educational 251 sessions were found to be essential to motivate the middle-aged women in their menopause. 252 This session helped participants by clarifying their doubts. Thus, as the findings of this study 253 were encouraging, there is now a reason to undertake extensive research along similar lines. 254 255 Osteoporotic fractures are the third-leading cause of disability; therefore, maintaining strong 256 bones is essential for extending a healthy lifespan. As various factors, including diet, exercise, 257 consumption of alcohol and tobacco products, and genetics, have an impact on bone mass, it is 258 very important to maintain bone health and prevent complications with a nutritious diet rich in 259 balanced nutrients, including calcium, vitamin D, and protein, as well as through regular 260 exercise and quitting smoking. Our study results are supported by previous literature, showed 261 that lifestyle modification interventions along with the pharmacological treatments among the 262 postmenopausal osteoporotic women were effective in bringing the positive results. Thus, it is 263 suggestive of the integration of lifestyle modifications in clinical practice while treating post-264 menopausal osteoporotic patients. 265 266 Limitations 267 There are several limitations to this study. First, the participants in the experimental group 268 would have discussed the intervention with the control group. However, for the intervention 269 group, participants’ intervention was provided in a separate room. Second, there was no 270 monitoring at home for compliance with LMIP. However, the LMIP developed for this study 271 was simple, low-cost, and convenient for the postmenopausal women to practice at home. 272 Third, despite the fact that DEXA is regarded as the gold standard for the diagnosis of 273 osteoporosis, BMD was measured using the ultrasound method in this study since it was 274 affordable and feasible for the study. Finally, the data collection was carried out during the 275 COVID-19 pandemic and lockdown, so we missed some of the postmenopausal women for the 276 follow up. However, the sample size was more than the estimated sample size and we could 277 manage the analysis. 278 279 Conclusion 280 The study revealed that lifestyle modification along with pharmacotherapy for postmenopausal 281 osteoporotic women was found to be effective. Regular implementation of this program for 282 women with primary osteoporosis who haven’t experienced the fracture yet will definitely help 283 to reverse the bone loss and bone health could be improved. Clinicians and nurses should focus 284 on lifestyle modification interventions in addition to pharmacotherapy because it is cost-285 effective and affordable for patients to prevent the most severe complications such as fracture. 286 287 Authors’ Contribution 288 ADS, JAN, KKVA conceptualized and designed the study. ADS did the data collection and 289 involved in the manuscript writing. JAN and KKVA supervised the work and edited the 290 manuscript. BSN and MP contributed to manuscript writing. RN was involved in data analysis. 291 All authors approved the final version of the manuscript. 292 293 Conflict of Interest 294 The authors declare no conflicts of interest . 295 296 Funding 297 No funding was received for this study. 298 299 References 300 1. Rachner TD, Khosla S, Hofbauer LC. Osteoporosis: now and the future. Lancet 301 2011;377:1276–87. https://doi.org/10.1016/S0140-6736(10)62349-5. 302 2. Sozen T, Ozisik L, Calik Basaran N. An overview and management of osteoporosis. 303 Eur J Rheumatol 2017;4:46–56. https://doi.org/10.5152/EURJRHEUM.2016.048. 304 3. Ji M, Yu Q. Primary osteoporosis in postmenopausal women. Chronic Dis Transl Med 305 2015;1:9–13. https://doi.org/10.1016/J.CDTM.2015.02.006. 306 4. Aypak C, Bircan MA, Özdemir A. Anti-osteoporotic Drug Utilization Rates for 307 Secondary Prevention Among Patients with Osteoporotic Fractures. Rambam 308 Maimonides Med J 2022;13. https://doi.org/10.5041/RMMJ.10473. 309 5. Minisola S, Cipriani C, Occhiuto M, Pepe J. New anabolic therapies for osteoporosis. 310 Intern Emerg Med 2017;12:915–21. https://doi.org/10.1007/S11739-017-1719-311 4/FIGURES/2. 312 6. Akkawi I, Zmerly H. Osteoporosis: Current Concepts. Joints 2018;6:122–7. 313 https://doi.org/10.1055/S-0038-1660790. 314 7. Park Y-S. Diagnosis and treatment of osteoporosis. Journal of the Korean Medical 315 Association 2012;55:1083–94. https://doi.org/10.5124/JKMA.2012.55.11.1083. 316 8. Pisani P, Renna MD, Conversano F. Casciaro E, Muratore M, Quarta E, et al. 317 Screening and early diagnosis of osteoporosis through X-ray and ultrasound based 318 techniques. World J Radiol 2013;5:398. https://doi.org/10.4329/WJR.V5.I11.398. 319 9. Ji M, Yu Q. Primary osteoporosis in postmenopausal women. Chronic Dis Transl Med 320 2015;1:9–13. https://doi.org/10.1016/J.CDTM.2015.02.006. 321 10. National osteoporosis guidelines group-UK. Non-pharmacological management of 322 osteoporosis | NOGG. Available at: https://www.nogg.org.uk/full-guideline/section-5-323 non-pharmacological-management-osteoporosis. Accessed January 5, 2023. 324 11. Zhu K, Prince RL. Lifestyle and osteoporosis. Curr Osteoporos Rep 2015;13:52–9. 325 https://doi.org/10.1007/S11914-014-0248-6. 326 12. Ishimi Y. Osteoporosis and Lifestyle. J Nutr Sci Vitaminol (Tokyo) 2015;61 327 Suppl:S139–41. https://doi.org/10.3177/JNSV.61.S139. 328 13. Benedetti MG, Furlini G, Zati A, Letizia Mauro G. The Effectiveness of Physical 329 Exercise on Bone Density in Osteoporotic Patients. Biomed Res Int 2018;2018. 330 https://doi.org/10.1155/2018/4840531. 331 14. Christianson MS, Shen W. Osteoporosis prevention and management: 332 nonpharmacologic and lifestyle options. Clin Obstet Gynecol 2013;56:703–10. 333 https://doi.org/10.1097/GRF.0B013E3182A9D15A. 334 15. Rajan R, Paul J, Kapoor N, Cherian KE, Paul TV. Postmenopausal osteoporosis – An 335 Indian perspective. Current Medical Issues 2020;18:98. 336 https://doi.org/10.4103/CMI.CMI_5_20. 337 16. Mohammad Rahimi GR, Smart NA, Liang MTC, Bijeh N, Albanaqi AL, Fathi M, et 338 al. The Impact of Different Modes of Exercise Training on Bone Mineral Density in 339 Older Postmenopausal Women: A Systematic Review and Meta-analysis Research. 340 Calcif Tissue Int 2020;106:577–90. https://doi.org/10.1007/S00223-020-00671-341 W/FIGURES/4. 342 17. Blalock SJ, Currey SS, DeVellis RF, DeVellis BM, Giorgino KB, Anderson JJ, et al. 343 Effects of educational materials concerning osteoporosis on women’s knowledge, 344 beliefs, and behavior. American Journal of Health Promotion 2000;14:161–9. 345 https://doi.org/10.4278/0890-1171-14.3.161. 346 18. McArthur D, Dumas A, Woodend K, Beach S, Stacey D. Factors influencing 347 adherence to regular exercise in middle-aged women: A qualitative study to inform 348 clinical practice. BMC Womens Health 2014;14:1–8. https://doi.org/10.1186/1472-349 6874-14-49/TABLES/2. 350 19. García-Sempere A, Hurtado I, Sanfélix-Genovés J, Rodríguez-Bernal C, Peiró S, 351 Sanfélix-Gimeno G. Improving the accuracy of medication adherence measures using 352 linked prescription and dispensation data: findings from the ESOSVAL cohort of 353 patients treated with osteoporosis drugs. Curr Med Res Opin 2019;10. 354 https://www.tandfonline.com/doi/10.1080/03007995.2019.1601944 355 20. Cornelissen D, de Kunder S, Si L, Reginster J, Evers S, Boonen A, et al. Interventions 356 to improve adherence to anti-osteoporosis medications: an updated systematic review. 357 Osteoporosis International 2020;31:1645–69. https://doi.org/10.1007/S00198-020-358 05378-0/TABLES/6. 359 21. Kuan CS, Yian CY, Kaur D, Singh DK, Mokhtar SA. Effectiveness of 360 Physiotherapeutic Group Education in Improving Quality of Life, Physical 361 Performance and Back Extensor Muscle Strength among. MedicUpmEduMy 362 2022;18:269–77. https://doi.org/10.47836/mjmhs18.s15.38. 363 22. Saggini R, Ancona E, Carmignano SM, Supplizi M, Barassi G, Bellomo RG. Effect of 364 combined treatment with focused mechano-acoustic vibration and pharmacological 365 therapy on bone mineral density and muscle strength in post-menopausal women. Clin 366 Cases Miner Bone Metab 2017;14:305–11. 367 https://doi.org/10.11138/CCMBM/2017.14.3.305. 368 23. Sahaya Rani G, Swaminathan A. Effectiveness Of Physical Activity And Diet 369 Supplementation On Body Mass Index And Bone Mineral Density Among 370 Premenopausal Women. J Pharm Negat Results 2022;13:4403–11. 371 https://doi.org/10.47750/PNR.2022.13.S07.552. 372 24. Razzak ZA, Khan AA, Farooqui SI. Effect of aerobic and anaerobic exercise on 373 estrogen level, fat mass, and muscle mass among postmenopausal osteoporotic 374 females. Int J Health Sci (Qassim) 2019;13:10. 375 25. Watson SL., Weeks BK, Weis LJ, Harding AT, Horan SA, Beck BR. High-Intensity 376 Resistance and Impact Training Improves Bone Mineral Density and Physical 377 Function in Postmenopausal Women With Osteopenia and Osteoporosis: The 378 LIFTMOR Randomized Controlled Trial. J Bone Miner Res 2018;33:211–20. 379 https://doi.org/10.1002/JBMR.3284. 380 26. Muir JM., Ye C, Bhandari M, Adachi JD, Thabane L. The effect of regular physical 381 activity on bone mineral density in post-menopausal women aged 75 and over: A 382 retrospective analysis from the Canadian multicentre osteoporosis study. BMC 383 Musculoskelet Disord 2013;14:1–9. https://doi.org/10.1186/1471-2474-14-384 253/TABLES/5. 385 27. Rizzoli R, Stevenson JC, Bauer JM, van Loon, L.J, Walrand S, Kanis, J.A, et al. The 386 role of dietary protein and vitamin D in maintaining musculoskeletal health in 387 postmenopausal women: a consensus statement from the European Society for Clinical 388 and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Maturitas 389 2014;79:122–32. https://doi.org/10.1016/J.MATURITAS.2014.07.005. 390 28. Muñoz-garach A, García-fontana B, Muñoz-torres M. Nutrients and Dietary Patterns 391 Related to Osteoporosis. Nutrients 2020;12:1–15. 392 https://doi.org/10.3390/NU12071986. 393 29. Guo D, Zhao M, Xu W, He H, Li B, Hou T. Dietary interventions for better 394 management of osteoporosis: An overview. Crit Rev Food Sci Nutr 2023;63. 395 https://doi.org/10.1080/10408398.2021.1944975. 396 30. Laslett LL, Lynch J, Sullivan TR., McNEIL JD. Osteoporosis education improves 397 osteoporosis knowledge and dietary calcium: comparison of a 4 week and a one-398 session education course. Int J Rheum Dis 2011;14:239–47. 399 https://doi.org/10.1111/J.1756-185X.2011.01628.X. 400 31. Howe TE., Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, et al. 401 Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane 402 Database Syst Rev 2011. https://doi.org/10.1002/14651858.CD000333.PUB2. 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 Assessed for eligibility -162 Excluded (n=42)  Not meeting inclusion criteria (n=25)  Had history of fracture and other diseases like cardiovascular, cancer etc-10  Joined for regular yoga classes-5  Declined to take part in study (n=2) Enrolment Randomized-120 Stratified block randomization 2 strata &12 blocks (1 block=10) Allocation Allocated to intervention group (n=60) Received LMIP (n=60) Allocated to control group (n=60) Received standard care (n=60) Follow up Follow up 1 Lost to follow up due to Covid-19 Pandemic lockdown (n=15) Follow up 1 Lost to follow up due to Covid-19 Pandemic lockdown (n=8) Follow up 2 Lost to follow up due to Covid-19 Pandemic lockdown (n=18) Follow up 2 Lost to follow up (BMD) due to Covid- 19 Pandemic lockdown (n=15) 424 425 426 427 Figure 1: CONSORT Flow diagram on Process of Randomized Controlled Trial 428 429 430 431 432 Table 1: Frequency and percentage distribution of demographic characteristics of 433 participants (N = 120) 434 Variable Experimental group (n=60) Control group (n=60) Overall P value Mean (SD) Freque ncy (f) Percent age (%) Frequenc y (f) Percent age (%) Mean (SD) Freque ncy (f) Percenta ge (%) Age in years 56.8 (2.5) 55.7 (1.8) Occupation Daily labour Housewife Others (govt. and private jobs) 1 44 15 1.7 73.3 25.0 2 41 17 3.3 68.3 28.3 3 85 32 2.5 70.83 26.66 0.242 Number of children 1 2 3 ≥4 9 24 17 10 15.0 40.0 28.3 16.7 6 27 20 7 10.0 45.0 33.3 11.7 15 51 37 17 12.5 42.5 30.83 14.17 0.332 Number of members in the family 1-4 5 and above 34 26 56.7 43.3 36 24 60 40 70 50 58.33 41.66 0.561 435 Table 2: Mann Whitney U value computed for pre-test, post-test 1 and post-test II of 436 BMD scores among intervention and control group 437 BMD measurements Group N Median (Q1, Q3) P value Analysis Analyzed (n) =42 Analyzed (n) =45 Pre-test Intervention 60 -2.2 (-2.5, -1.8) 0.431 Control 60 -2.3 (-2.6, -1.9) Post-test 1 Intervention 45 -1.3 (-2.5, -1.0) 0.126 Control 52 -1.8 (-2.4, -1.5) Post-test II Intervention 42 -1.5 (-1.8, 0.65) <0.001 Control 43 -2.0 (-2.4, -1.5) 438 439 440 Table 3: Wilcoxon Signed Rank Test results to compare the change in BMD Scores 441 within Intervention and Control Groups from pre-test to post-test I and II. 442 BMD Groups Z score P-value Pre-test to Post-test I Intervention (n=60) -5.591 <0.001 Control (n=60) -5.509 <0.001 Pre-test to Post-test II Intervention (n=45) -5.556 <0.001 Control (n=52) -5.172 <0.001 Post-test I to Post-test II Intervention (n=42) -3.626 <0.001 Control (n=45) -3.352 <0.001 *To adjust for multiple comparisons, P-value < 0.05/3 was considered as statistically 443 significant. 444