Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-02
Study Completion Date
2024-12-30
Brief Summary
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The aim of the study is to analyze the effects of Nordic Walking and free walking in the clinical-functional, postural balance, motor control, muscular echographic quality, and gait analysis (pendulum gait mechanism), in people with Multiple Sclerosis.
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Detailed Description
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Objective: Analyze the effects of Nordic Walking and free walking in the clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, in people with Multiple sclerosis. Experimental Design: Randomized controlled multicenter clinical trial with translational study characteristics. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Brazil, and University of Pavia, on Department of Public Health, Experimental Medicine and Forensic Sciences, Pavia, Italy. Participants: 60 patients from the Unified Health System (UHS) of both sexes, from 20 to 75 years old, diagnosed with multiple sclerosis, sedentary. Interventions: In this research, four groups of patients with multiple sclerosis will receive intervention during 4 months of different physical therapy programs (Nordic walking and free walking), who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 3 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. To evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session. Outcomes: clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, and biochemistry. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05. Expected Results: The intervention groups of the Nordic walking are expected to be more effective in all outcomes analyzed, especially improving functional mobility when compared to the control group of unsupervised home exercises. In addition, it is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social, and environmental fields and that they will be implemented in the Unified Health System (UHS).
Conditions
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Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Secondary Progressive
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Study Type: Interventional, Randomized controlled multicenter clinical trial In this research, four groups of patients with Parkinson's disease will receive intervention during 4 months of different physical therapy programs (Nordic walking) and free walking, who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Caregivers
Investigators
Outcome Assessors
double-blind (Investigator, Outcomes Assessor, Care Provider)
Study Groups
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Nordic Walking (NWG)
The Nordic Walk program consists of 3 moments:
warm-up, walk, and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed - SSWS (3 'SSWS), then walk according to the training cycle, the intensity will be between 60 to 80% of the Heart of Ratio reserve. In addition, the intensity of the classes will be measured in each phase by the Borg Scale of Perceived Exertion.
Group Type
EXPERIMENTAL
Nordic Walking (NWG)
Intervention Type
OTHER
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Free Walking (FWG)
Intervention Type
OTHER
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Health Education (HEG)
Intervention Type
OTHER
The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
Free walking (FWG)
The free walking program consists of 3 moments:
warm-up, walk, and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed - SSWS (3 'SSWS), then walk according to the training cycle, the intensity will be between 60 to 80% of the Heart of Ratio reserve. In addition, the intensity of the classes will be measured in each phase by the Borg Scale of Perceived Exertion.
Intervention administered:
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Group Type
ACTIVE_COMPARATOR
Nordic Walking (NWG)
Intervention Type
OTHER
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Free Walking (FWG)
Intervention Type
OTHER
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Health Education (HEG)
Intervention Type
OTHER
The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
Health Education (HEG)
The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Nordic Walking (NWG)
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Intervention Type
OTHER
Free Walking (FWG)
24 sessions will be held twice a week, with each session taking an average of 60 minutes.
Intervention Type
OTHER
Health Education (HEG)
The control group will receive orientation and carry out the "Health Education" program and will have a duration of 3 months.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* volunteers aged over 20 years;
* of both sexes;
* with a clinical diagnosis of multiple sclerosis.
* of both sexes;
* with a clinical diagnosis of multiple sclerosis.
Exclusion Criteria
* severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
* stroke or other associated neurological diseases; insanity;
* prostheses in the lower limbs;
* without ambulation conditions.
* stroke or other associated neurological diseases; insanity;
* prostheses in the lower limbs;
* without ambulation conditions.
Minimum Eligible Age
20 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Aline Nogueira Haas
UNKNOWN
Sponsor Role
collaborator
Flávia Gomes Martinez
UNKNOWN
Sponsor Role
collaborator
Leonardo A. Peyré-Tartaruga
OTHER
Sponsor Role
lead
Responsible Party
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Leonardo A. Peyré-Tartaruga
Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
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Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
Countries
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Brazil
References
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Balbinot G, Schuch CP, Bianchi Oliveira H, Peyre-Tartaruga LA. Mechanical and energetic determinants of impaired gait following stroke: segmental work and pendular energy transduction during treadmill walking. Biol Open. 2020 Jul 21;9(7):bio051581. doi: 10.1242/bio.051581.
Reference Type
BACKGROUND
Baker NA, Tickle-Degnen L. The effectiveness of physical, psychological, and functional interventions in treating clients with multiple sclerosis: a meta-analysis. Am J Occup Ther. 2001 May-Jun;55(3):324-31. doi: 10.5014/ajot.55.3.324.
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BACKGROUND
Cavagna GA, Thys H, Zamboni A. The sources of external work in level walking and running. J Physiol. 1976 Nov;262(3):639-57. doi: 10.1113/jphysiol.1976.sp011613.
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BACKGROUND
Chung KC, Song JW; WRIST Study Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg. 2010 Aug;126(2):515-523. doi: 10.1097/PRS.0b013e3181df64fa.
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BACKGROUND
Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain. 2003 Apr;126(Pt 4):770-82. doi: 10.1093/brain/awg081.
Reference Type
BACKGROUND
Correale L, Buzzachera CF, Liberali G, Codrons E, Mallucci G, Vandoni M, Montomoli C, Bergamaschi R. Effects of Combined Endurance and Resistance Training in Women With Multiple Sclerosis: A Randomized Controlled Study. Front Neurol. 2021 Aug 5;12:698460. doi: 10.3389/fneur.2021.698460. eCollection 2021.
Reference Type
BACKGROUND
Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyre-Tartaruga LA, Haas AN. Can Samba and Forro Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease? BMC Neurol. 2020 Aug 18;20(1):305. doi: 10.1186/s12883-020-01878-y.
Reference Type
BACKGROUND
Detrembleur C, van den Hecke A, Dierick F. Motion of the body centre of gravity as a summary indicator of the mechanics of human pathological gait. Gait Posture. 2000 Dec;12(3):243-50. doi: 10.1016/s0966-6362(00)00081-3.
Reference Type
BACKGROUND
Gomenuka NA, Oliveira HB, da Silva ES, Passos-Monteiro E, da Rosa RG, Carvalho AR, Costa RR, Rodriguez Paz MC, Pellegrini B, Peyre-Tartaruga LA. Nordic walking training in elderly, a randomized clinical trial. Part II: Biomechanical and metabolic adaptations. Sports Med Open. 2020 Jan 13;6(1):3. doi: 10.1186/s40798-019-0228-6.
Reference Type
BACKGROUND
Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23.
Reference Type
BACKGROUND
MONTEIRO, Elren Passos et al. Aspectos biomecânicos da locomoção de pessoas com doença de Parkinson: revisão narrativa. Revista Brasileira de Ciências do Esporte, v. 39, p. 450-457, 2017.
Reference Type
BACKGROUND
Motl RW, Sandroff BM. Benefits of Exercise Training in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2015 Sep;15(9):62. doi: 10.1007/s11910-015-0585-6.
Reference Type
BACKGROUND
O'CONNELL, R. et al. A controlled study to assess the effects of aerobic training on patients with multiple sclerosis. 14th International World Confederation for Physical Therapy, 2003.
Reference Type
BACKGROUND
Passos-Monteiro E, B Schuch F, T Franzoni L, R Carvalho A, A Gomenuka N, Becker M, Rieder CRM, Andrade A, G Martinez F, S Pagnussat A, A Peyre-Tartaruga L. Nordic Walking and Free Walking Improve the Quality of Life, Cognitive Function, and Depressive Symptoms in Individuals with Parkinson's Disease: A Randomized Clinical Trial. J Funct Morphol Kinesiol. 2020 Nov 10;5(4):82. doi: 10.3390/jfmk5040082.
Reference Type
BACKGROUND
Patti F, Ciancio MR, Cacopardo M, Reggio E, Fiorilla T, Palermo F, Reggio A, Thompson AJ. Effects of a short outpatient rehabilitation treatment on disability of multiple sclerosis patients--a randomised controlled trial. J Neurol. 2003 Jul;250(7):861-6. doi: 10.1007/s00415-003-1097-x.
Reference Type
BACKGROUND
Peyre-Tartaruga LA, Martinez FG, Zanardi APJ, Casal MZ, Donida RG, Delabary MS, Passos-Monteiro E, Coertjens M, Haas AN. Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. Sport Sci Health. 2022;18(4):1119-1127. doi: 10.1007/s11332-022-00894-4. Epub 2022 Feb 17.
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BACKGROUND
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
Reference Type
BACKGROUND
Psarakis M, Greene D, Moresi M, Baker M, Stubbs P, Brodie M, Lord S, Hoang P. Impaired heel to toe progression during gait is related to reduced ankle range of motion in people with Multiple Sclerosis. Clin Biomech (Bristol). 2017 Nov;49:96-100. doi: 10.1016/j.clinbiomech.2017.08.012. Epub 2017 Sep 1.
Reference Type
BACKGROUND
Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003980. doi: 10.1002/14651858.CD003980.pub2.
Reference Type
BACKGROUND
Schepens B, Bastien GJ, Heglund NC, Willems PA. Mechanical work and muscular efficiency in walking children. J Exp Biol. 2004 Feb;207(Pt 4):587-96. doi: 10.1242/jeb.00793.
Reference Type
BACKGROUND
SOARES, Gustavo da Silva; PEYRÉ-TARTARUGA, Leonardo Alexandre. Doença de Parkinson e exercício físico: uma revisão da literatura. Ciência em Movimento, v. 12, n. 24, p. 69-85, 2010.
Reference Type
BACKGROUND
Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061/2011/232473. Epub 2011 Mar 30.
Reference Type
BACKGROUND
Tschentscher M, Niederseer D, Niebauer J. Health benefits of Nordic walking: a systematic review. Am J Prev Med. 2013 Jan;44(1):76-84. doi: 10.1016/j.amepre.2012.09.043.
Reference Type
BACKGROUND
YASINSKAYA, Yana Konstantinovna. DEVELOPMENT OF STATIC AND DYNAMIC BALANCE IN INDIVIDUALS WITH MULTIPLE SCLEROSIS BASED ON THE USE OF THE NORDIC WALKING METHOD. имени ПФ Лесгафта, n. 12, p. 320, 2014.
Reference Type
BACKGROUND
WILLEMS, P.-A.; SCHEPENS, Bénédicte; DETREMBLEUR, Christine. Marcha normal. EMC-Kinesiterapia-Medicina Física, v. 33, n. 2, p. 1-29, 2012.
Reference Type
BACKGROUND
Zanardi APJ, da Silva ES, Costa RR, Passos-Monteiro E, Dos Santos IO, Kruel LFM, Peyre-Tartaruga LA. Gait parameters of Parkinson's disease compared with healthy controls: a systematic review and meta-analysis. Sci Rep. 2021 Jan 12;11(1):752. doi: 10.1038/s41598-020-80768-2.
Reference Type
BACKGROUND
Boeschoten RE, Braamse AMJ, Beekman ATF, Cuijpers P, van Oppen P, Dekker J, Uitdehaag BMJ. Prevalence of depression and anxiety in Multiple Sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2017 Jan 15;372:331-341. doi: 10.1016/j.jns.2016.11.067. Epub 2016 Nov 30.
Reference Type
RESULT
Casal MZ, Peyre-Tartaruga LA, Zanardi APJ, Ivaniski-Mello A, Alves LL, Haas AN, Martinez FG. Postural Adjustments and Biomechanics During Gait Initiation and Obstacle Negotiation: A Comparison Between Akinetic-Rigid and Hyperkinetic Parkinson's Disease. Front Physiol. 2021 Nov 4;12:723628. doi: 10.3389/fphys.2021.723628. eCollection 2021.
Reference Type
RESULT
Cavagna GA, Willems PA, Legramandi MA, Heglund NC. Pendular energy transduction within the step in human walking. J Exp Biol. 2002 Nov;205(Pt 21):3413-22. doi: 10.1242/jeb.205.21.3413.
Reference Type
RESULT
Frazzitta G, Balbi P, Maestri R, Bertotti G, Boveri N, Pezzoli G. The beneficial role of intensive exercise on Parkinson disease progression. Am J Phys Med Rehabil. 2013 Jun;92(6):523-32. doi: 10.1097/PHM.0b013e31828cd254.
Reference Type
RESULT
Gomenuka NA, Bona RL, da Rosa RG, Peyre-Tartaruga LA. The pendular mechanism does not determine the optimal speed of loaded walking on gradients. Hum Mov Sci. 2016 Jun;47:175-185. doi: 10.1016/j.humov.2016.03.008. Epub 2016 Mar 24.
Reference Type
RESULT
Gulde P, Hermsdorfer J, Rieckmann P. Speed but Not Smoothness of Gait Reacts to Rehabilitation in Multiple Sclerosis. Mult Scler Int. 2021 Jun 3;2021:5589562. doi: 10.1155/2021/5589562. eCollection 2021.
Reference Type
RESULT
Halabchi F, Alizadeh Z, Sahraian MA, Abolhasani M. Exercise prescription for patients with multiple sclerosis; potential benefits and practical recommendations. BMC Neurol. 2017 Sep 16;17(1):185. doi: 10.1186/s12883-017-0960-9.
Reference Type
RESULT
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.
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RESULT
Kelleher KJ, Spence W, Solomonidis S, Apatsidis D. The characterisation of gait patterns of people with multiple sclerosis. Disabil Rehabil. 2010;32(15):1242-50. doi: 10.3109/09638280903464497.
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RESULT
Kim Y, Lai B, Mehta T, Thirumalai M, Padalabalanarayanan S, Rimmer JH, Motl RW. Exercise Training Guidelines for Multiple Sclerosis, Stroke, and Parkinson Disease: Rapid Review and Synthesis. Am J Phys Med Rehabil. 2019 Jul;98(7):613-621. doi: 10.1097/PHM.0000000000001174.
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RESULT
Kuo AD, Donelan JM. Dynamic principles of gait and their clinical implications. Phys Ther. 2010 Feb;90(2):157-74. doi: 10.2522/ptj.20090125. Epub 2009 Dec 18.
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RESULT
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
Reference Type
RESULT
Leal-Nascimento AH, da Silva ES, Zanardi APJ, Ivaniski-Mello A, Passos-Monteiro E, Martinez FG, Rodrigo de Carvalho A, Baptista RR, Peyre-Tartaruga LA. Biomechanical responses of Nordic walking in people with Parkinson's disease. Scand J Med Sci Sports. 2022 Feb;32(2):290-297. doi: 10.1111/sms.14095. Epub 2021 Dec 7.
Reference Type
RESULT
Martinez-Lemos I, Martinez-Aldao D, Seijo-Martinez M, Ayan C. Nordic walking for people with relapsing-remittent multiple sclerosis: A case series study. Mult Scler Relat Disord. 2020 Nov;46:102479. doi: 10.1016/j.msard.2020.102479. Epub 2020 Sep 3.
Reference Type
RESULT
Nardello F, Ardigo LP, Minetti AE. Measured and predicted mechanical internal work in human locomotion. Hum Mov Sci. 2011 Feb;30(1):90-104. doi: 10.1016/j.humov.2010.05.012. Epub 2010 Nov 5.
Reference Type
RESULT
Nogueira LA, Teixeira L, Sabino P, Filho HA, Alvarenga RM, Thuler LC. Gait characteristics of multiple sclerosis patients in the absence of clinical disability. Disabil Rehabil. 2013 Aug;35(17):1472-8. doi: 10.3109/09638288.2012.738760.
Reference Type
RESULT
Peyre-Tartaruga LA, Dewolf AH, di Prampero PE, Fabrica G, Malatesta D, Minetti AE, Monte A, Pavei G, Silva-Pereyra V, Willems PA, Zamparo P. Mechanical work as a (key) determinant of energy cost in human locomotion: recent findings and future directions. Exp Physiol. 2021 Sep;106(9):1897-1908. doi: 10.1113/EP089313. Epub 2021 Jul 14.
Reference Type
RESULT
Proschinger S, Kuhwand P, Rademacher A, Walzik D, Warnke C, Zimmer P, Joisten N. Fitness, physical activity, and exercise in multiple sclerosis: a systematic review on current evidence for interactions with disease activity and progression. J Neurol. 2022 Jun;269(6):2922-2940. doi: 10.1007/s00415-021-10935-6. Epub 2022 Jan 27.
Reference Type
RESULT
Saibene F, Minetti AE. Biomechanical and physiological aspects of legged locomotion in humans. Eur J Appl Physiol. 2003 Jan;88(4-5):297-316. doi: 10.1007/s00421-002-0654-9. Epub 2002 Nov 13.
Reference Type
RESULT
Zigmond MJ, Smeyne RJ. Exercise: is it a neuroprotective and if so, how does it work? Parkinsonism Relat Disord. 2014 Jan;20 Suppl 1:S123-7. doi: 10.1016/S1353-8020(13)70030-0.
Reference Type
RESULT
Other Identifiers
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MUSCLE
Identifier Type: -
Identifier Source: org_study_id
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