Effects of Resistance Training and Nutritional Support on Osteosarcopenia in Older, Community-dwelling Postmenopausal Korean Females (ERTO-K Study): a Study Protocol

Overview

Journal BMC Geriatr

Publisher Biomed Central

Specialty Geriatrics

Date 2024 Jan 16

PMID 38229012

Authors

Byung Chan Lee

Kyung Il Kim

Kang Hee Cho

Chang-Won Moon

Affiliations

Soon will be listed here.

Abstract

Background: Osteosarcopenia is geriatric syndrome defined as the concomitant occurrence of osteopenia/osteoporosis, and sarcopenia. Osteosarcopenia is a relatively new concept in geriatric medicine; however, it may increase the risk of fragility fractures, several morbidities and mortalities, and socioeconomic costs. Although resistance exercises and nutritional support-including protein, calcium, and vitamin D-are potential non-pharmacological management procedures, evidence is still lacking. The objective of this study was therefore to evaluate the effect of combined resistance exercise and nutritional support on the quality and quantity of bone and muscle in postmenopausal females with osteosarcopenia.

Methods: This research proposal presents the protocol for a prospective, single-center, single-blinded, two-armed randomized controlled trial. Thirty-four participants with osteosarcopenia will be recruited and randomly divided into intervention and control groups; both groups will receive nutritional supplements (protein, 40 g; vitamin D, 1600 IU; calcium, 600 mg) daily. The intervention group will undergo 24 weeks of resistance exercise of increasing intensity, achieved through a three-phase step-up process. The primary outcomes will be the changes in skeletal muscle index and bone marrow density of the lumbar spine and femoral neck between the baseline and end of intervention (24 weeks). The secondary outcomes will be the body composition, whole body phase angle, physical function assessment, quality of life, psychological assessment, and bone turnover markers of participants, surveyed at multiple time points.

Discussion: This randomized controlled trial may reveal the effect of resistance exercise and nutritional support on older postmenopausal women with osteosarcopenia. The results will provide evidence for developing proper non-pharmacological management guidelines for postmenopausal women.

Trial Registration: Clinical Research Information Service of Republic of Korea, KCT0008291, Registered on 16 March 2023, https://cris.nih.go.kr/cris/search/detailSearch.do/25262 .

Citing Articles

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PMID: 38674833 PMC: 11054152. DOI: 10.3390/nu16081141.

References

Bauer D, Garnero P, Harrison S, Cauley J, Eastell R, Ensrud K . Biochemical markers of bone turnover, hip bone loss, and fracture in older men: the MrOS study. J Bone Miner Res. 2009; 24(12):2032-8. PMC: 2791517. DOI: 10.1359/jbmr.090526. View

Clynes M, Gregson C, Bruyere O, Cooper C, Dennison E . Osteosarcopenia: where osteoporosis and sarcopenia collide. Rheumatology (Oxford). 2020; 60(2):529-537. DOI: 10.1093/rheumatology/keaa755. View

Yoo J, Kim H, Ha Y, Kwon H, Koo K . Osteosarcopenia in Patients with Hip Fracture Is Related with High Mortality. J Korean Med Sci. 2018; 33(4):e27. PMC: 5760812. DOI: 10.3346/jkms.2018.33.e27. View

Lichtenberg T, von Stengel S, Sieber C, Kemmler W . The Favorable Effects of a High-Intensity Resistance Training on Sarcopenia in Older Community-Dwelling Men with Osteosarcopenia: The Randomized Controlled FrOST Study. Clin Interv Aging. 2020; 14:2173-2186. PMC: 6924654. DOI: 10.2147/CIA.S225618. View

Han C, Jo S, Kwak J, Pae C, Steffens D, Jo I . Validation of the Patient Health Questionnaire-9 Korean version in the elderly population: the Ansan Geriatric study. Compr Psychiatry. 2008; 49(2):218-23. DOI: 10.1016/j.comppsych.2007.08.006. View

Steele J, Fisher J, Giessing J, Gentil P . Clarity in reporting terminology and definitions of set endpoints in resistance training. Muscle Nerve. 2017; 56(3):368-374. DOI: 10.1002/mus.25557. View

Bauer J, Biolo G, Cederholm T, Cesari M, Cruz-Jentoft A, Morley J . Evidence-based recommendations for optimal dietary protein intake in older people: a position paper from the PROT-AGE Study Group. J Am Med Dir Assoc. 2013; 14(8):542-59. DOI: 10.1016/j.jamda.2013.05.021. View

Norman K, Stobaus N, Gonzalez M, Schulzke J, Pirlich M . Hand grip strength: outcome predictor and marker of nutritional status. Clin Nutr. 2010; 30(2):135-42. DOI: 10.1016/j.clnu.2010.09.010. View

Bauer J, Morley J, Schols A, Ferrucci L, Cruz-Jentoft A, Dent E . Sarcopenia: A Time for Action. An SCWD Position Paper. J Cachexia Sarcopenia Muscle. 2019; 10(5):956-961. PMC: 6818450. DOI: 10.1002/jcsm.12483. View

10.

Campa F, Toselli S, Mazzilli M, Gobbo L, Coratella G . Assessment of Body Composition in Athletes: A Narrative Review of Available Methods with Special Reference to Quantitative and Qualitative Bioimpedance Analysis. Nutrients. 2021; 13(5). PMC: 8150618. DOI: 10.3390/nu13051620. View

11.

Kaiser M, Bauer J, Ramsch C, Uter W, Guigoz Y, Cederholm T . Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009; 13(9):782-8. DOI: 10.1007/s12603-009-0214-7. View

12.

Chan A, Tetzlaff J, Gotzsche P, Altman D, Mann H, Berlin J . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 346:e7586. PMC: 3541470. DOI: 10.1136/bmj.e7586. View

13.

Akamatsu Y, Kusakabe T, Arai H, Yamamoto Y, Nakao K, Ikeue K . Phase angle from bioelectrical impedance analysis is a useful indicator of muscle quality. J Cachexia Sarcopenia Muscle. 2021; 13(1):180-189. PMC: 8818694. DOI: 10.1002/jcsm.12860. View

14.

Wilkinson J, Morris R, Martin-Fernandez M, Pozo J, Frangi A, Maheson M . Use of high resolution dual-energy x-ray absorptiometry-region free analysis (DXA-RFA) to detect local periprosthetic bone remodeling events. J Orthop Res. 2015; 33(5):712-6. DOI: 10.1002/jor.22823. View

15.

Campa F, Colognesi L, Moro T, Paoli A, Casolo A, Santos L . Effect of resistance training on bioelectrical phase angle in older adults: a systematic review with Meta-analysis of randomized controlled trials. Rev Endocr Metab Disord. 2022; 24(3):439-449. PMC: 10140106. DOI: 10.1007/s11154-022-09747-4. View

16.

Morton R, Murphy K, McKellar S, Schoenfeld B, Henselmans M, Helms E . A systematic review, meta-analysis and meta-regression of the effect of protein supplementation on resistance training-induced gains in muscle mass and strength in healthy adults. Br J Sports Med. 2017; 52(6):376-384. PMC: 5867436. DOI: 10.1136/bjsports-2017-097608. View

17.

Dent E, Morley J, Cruz-Jentoft A, Arai H, Kritchevsky S, Guralnik J . International Clinical Practice Guidelines for Sarcopenia (ICFSR): Screening, Diagnosis and Management. J Nutr Health Aging. 2018; 22(10):1148-1161. DOI: 10.1007/s12603-018-1139-9. View

18.

Giangregorio L, Papaioannou A, MacIntyre N, Ashe M, Heinonen A, Shipp K . Too Fit To Fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. Osteoporos Int. 2013; 25(3):821-35. PMC: 5112023. DOI: 10.1007/s00198-013-2523-2. View

19.

Kemmler W, Kohl M, Jakob F, Engelke K, von Stengel S . Effects of High Intensity Dynamic Resistance Exercise and Whey Protein Supplements on Osteosarcopenia in Older Men with Low Bone and Muscle Mass. Final Results of the Randomized Controlled FrOST Study. Nutrients. 2020; 12(8). PMC: 7468852. DOI: 10.3390/nu12082341. View

20.

Brown J, Don-Wauchope A, Douville P, Albert C, Vasikaran S . Current use of bone turnover markers in the management of osteoporosis. Clin Biochem. 2022; 109-110:1-10. DOI: 10.1016/j.clinbiochem.2022.09.002. View