[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06870968":3,"trial-entities:NCT06870968":220,"trial-summary:NCT06870968":224},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":40,"interventions":43,"primary_outcomes":59,"secondary_outcomes":77,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":92,"locations":95,"central_contacts":165,"overall_officials":168,"references":169,"see_also_links":219},"NCT06870968","1000080992","FIT-ATOMIC Exercise Feasibility Trial","An Exercise Training Intervention for Depressive Symptoms in Youth With MS: A Randomized Controlled Feasibility Trial","NOT_YET_RECRUITING","2026-09-30","2024-09","2025-05-21","2025-06","The Hospital for Sick Children","OTHER",false,"This multi-center, randomized controlled feasibility trial will assess a 20-week home-based exercise intervention in youth with Multiple Sclerosis (MS). The goal is to determine the feasibility of conducting a larger, definitive trial on exercise training as a non-pharmacological approach to improve disease outcomes in this population.\n\nParticipants will be randomized to either an Exercise Training group or a Mobility and Flexibility Training group. The investigators will evaluate differences between the two groups in physical activity levels, mediators of physical activity, and psychosocial outcomes. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will occur at baseline and after 20 weeks. Accelerometry will be done at baseline, 10 weeks, and 20 weeks to track physical activity.\n\nThe primary objectives are to assess the feasibility of recruiting, retaining, and randomizing youth with MS and to evaluate adherence to the exercise intervention and coaching sessions. Exploratory objectives include examining changes in depressive symptoms, cognitive function, blood biomarkers (BDNF and irisin), brain volume, and fitness levels in response to the intervention.\n\nApproximately 40 participants will be enrolled from four sites in Canada and the United States.\n\nPrimary outcomes include feasibility, acceptability, and fidelity measures. Exploratory outcomes include blood biomarkers, brain MRI, cognitive testing, and other neuropsychological measures.","Overview: This research study explores the potential of exercise as a non-pharmacological treatment for youth with Multiple Sclerosis (MS). The investigators are conducting a 20-week home-based exercise program to determine if it is feasible to implement this type of intervention in a larger trial in the future. Our ultimate goal is to understand how exercise might help improve both physical and mental health outcomes for youth with MS.\n\nWhy This Study is Important: Multiple Sclerosis is a chronic disease that affects the brain and spinal cord, often leading to issues with movement, balance, vision, and other body functions. In young people, MS can have a significant impact on daily life, including mental health and cognitive abilities (such as memory and problem-solving). Medications can help manage symptoms, but there is growing interest in non-medication approaches, like exercise, to enhance the overall well-being of youth with MS. This study aims to investigate whether a structured exercise program can benefit physical fitness, mental health, and brain function in young people living with MS.\n\nStudy Design: This feasibility trial will enroll approximately 40 participants from four different locations in Canada and the United States. These participants will be youth diagnosed with MS.\n\nParticipants will be randomly assigned to one of two groups:\n\n1. Exercise Training Group: Participants will follow a 20-week home-based exercise program, which includes structured exercises designed to improve physical fitness.\n2. Mobility and Flexibility Training: Participants in this group will follow a 20-week program focused on mobility and flexibility exercises.\n\nThe study will collect data through various assessments, including:\n\n* Clinical Exams: To monitor physical health and MS-related symptoms.\n* Brain MRI: To measure changes in brain structure.\n* Eye Tracking (SickKids participants only): To assess brain activity and cognitive functions.\n* Cognitive Testing: To evaluate memory, attention, and other cognitive abilities.\n* Blood Draws: To measure blood biomarkers related to brain health, such as Brain-Derived Neurotrophic Factor (BDNF) and irisin, which are proteins thought to be linked to exercise benefits.\n* Questionnaires: To gather information on mental health, including levels of depression and overall well-being.\n* Accelerometry: To measure physical activity levels throughout the study.\n\nWhat the Investigators Hope to Learn: The main goal of this study is to see whether it is practical to run a large-scale trial using a home-based exercise program for youth with MS. The investigators will look at whether it is possible to successfully recruit, retain, and engage participants in the program and how well they adhere to the exercise plan.\n\nIn addition to feasibility, the study has several exploratory objectives:\n\n1. Mental Health: The investigators want to see if participants in the exercise group show improvements in depressive symptoms compared to the control group.\n2. Cognition: The investigators will evaluate whether exercise has a positive effect on thinking skills, such as memory and attention.\n3. Brain Health: Through brain MRI scans, the investigators will examine whether exercise protects or enhances brain volume in areas linked to MS.\n4. Fitness Levels: The investigators will measure if participants improve their physical fitness as a result of the exercise program.\n5. Biomarkers: The investigators will study how exercise impacts blood levels of BDNF and irisin, which may provide insight into the biological mechanisms behind the benefits of exercise.\n\nWhy It Matters: This study is a critical first step in determining if exercise can be a viable and effective way to improve the lives of youth with MS. If successful, the findings will pave the way for a larger trial that could lead to new, non-medication-based treatments to improve mental health, cognitive function, and overall well-being in young people with MS.\n\nBy addressing the gaps in understanding how exercise benefits youth with MS, this research could offer valuable insights into developing better care strategies for this population. The results will inform not only how future exercise programs are designed but also provide a deeper understanding of the biological mechanisms linking physical activity to brain health and mood in youth with MS.\n\nStudy Locations: The study will take place across four sites:\n\n* SickKids (Toronto, Canada)\n* Stollery Children's Hospital (Edmonton, Canada)\n* Children's Hospital of Philadelphia (Philadelphia, USA)\n* University of California, San Diego (San Diego, USA)\n\nHow This Study Will Help in the Future: The information the investigators gather from this feasibility trial will help shape a larger, more definitive study to further explore whether exercise can be widely implemented as a safe and effective treatment option for youth with MS. It could lead to new therapeutic strategies that do not rely solely on medication but focus on holistic approaches to health and wellness.",[19,20],"Neuroinflammatory Diseases","Multiple Sclerosis",[22,23,24,25,26,27,28,29,30,31,32,33,34,35],"multiple sclerosis","physical activity","depression","exercise intervention","biomarkers","irisin","brain-derived neurotrophic factor BDNF","randomized controlled trial","feasibility study","home-based exercise","youth","children","pediatric","brain and mental health","INTERVENTIONAL","BASIC_SCIENCE",[39],"NA",{"count":41,"type":42},40,"ESTIMATED",[44,52],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":50},"BEHAVIORAL","Exercise Training","The Exercise Training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones. The session will be delivered via a live feed in order to foster social support from the participants peers enrolled in the program. Participants will have the option of completing the class in real-time and make up classes will also be available through a repository of sessions accessible through links to the repository cloud.",[49],"Exercise Training Group",[51],"Exercise Program for Youth with MS",{"type":45,"name":53,"description":54,"armGroupLabels":55,"otherNames":57},"Mobility and Flexibility Training","The Mobility and Flexibility Training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise intervention arm with a virtual link sent to the participants.",[56],"Mobility & Flexibility Training Group",[58],"Mobility and Flexibility Training Program",[60,64,68,71,74],{"measure":61,"description":62,"timeFrame":63},"Participant accrual rate","Number of participants enrolled per year","From enrollment to the end of study",{"measure":65,"description":66,"timeFrame":67},"Fidelity of delivering the intervention","ASPIRE fidelity coaching checklist. This measure assesses the fidelity with which study coaches deliver the intervention during calls with participants. Participants are scored on a scale from 0 to 2, based on the extent to which the intervention components are covered:\n\n0: Did not cover - The intervention component was not addressed during the call.\n\n1. Partially covered - The intervention component was addressed to some extent, but not fully.\n2. Fully covered - The intervention component was fully addressed, meeting the intended criteria for delivery.\n\nA higher score reflects a more complete and accurate delivery of the intervention as planned.","From enrollment to the end of intervention at 20 weeks",{"measure":69,"description":70,"timeFrame":63},"Participant drop-out rate","Percentage of total patients that dropped out of study.",{"measure":72,"description":73,"timeFrame":63},"Adverse event rate","Number of adverse events per total participants",{"measure":75,"description":76,"timeFrame":63},"Completion rate of study measures","Percentage of total patients that completed the study measures.",[],"ALL","11 Years","25 Years",{"inclusion":82,"exclusion":86,"raw_text":91},[83,84,85],"Youth and young adults 11-25 years of age","MS diagnosis or clinically isolated syndrome per revised McDonald diagnostic criteria and International Pediatric MS Study Group Criteria","A score of 10 or above on the CES-DC scale.",[87,88,89,90],"Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities","Do not speak and read English at a level needed to complete the questionnaires (4th grade level)","Have significant motor disability (EDSS ≥4)","Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician","Inclusion Criteria:\n\n* Youth and young adults 11-25 years of age\n* MS diagnosis or clinically isolated syndrome per revised McDonald diagnostic criteria and International Pediatric MS Study Group Criteria\n* A score of 10 or above on the CES-DC scale.\n\nExclusion Criteria:\n\n* Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities\n* Do not speak and read English at a level needed to complete the questionnaires (4th grade level)\n* Have significant motor disability (EDSS ≥4)\n* Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician",[93,94],"CHILD","ADULT",[96,117,134,148],{"facility":97,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":114},"University of California, San Diego","La Jolla","California","92093","United States",[103,108,112],{"name":104,"role":105,"phone":106,"email":107},"Jennifer Graves, MD","CONTACT","858-246-2384","jgraves@health.ucsd.edu",{"name":109,"role":105,"phoneExt":110,"email":111},"Sophie Zacharek","858-246-2905","szacharek@health.ucsd.edu",{"name":104,"role":113},"PRINCIPAL_INVESTIGATOR",{"lat":115,"lon":116},32.84727,-117.2742,{"facility":118,"city":119,"state":120,"zip":121,"country":101,"contacts":122,"geoPoint":131},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[123,126,128],{"name":124,"role":105,"email":125},"Gerry Liu","liug@chop.edu",{"name":127,"role":113},"Sona Narula, MD",{"name":129,"role":130},"Amy Waldman, MD","SUB_INVESTIGATOR",{"lat":132,"lon":133},39.95238,-75.16362,{"facility":135,"city":136,"state":137,"zip":138,"country":139,"contacts":140,"geoPoint":145},"Stollery Children's Hospital","Edmonton","Alberta","T6G 2B7","Canada",[141,144],{"name":142,"role":105,"email":143},"Colin Wilbur, MD","colin.wilbur@albertahealthservices.ca",{"name":142,"role":113},{"lat":146,"lon":147},53.55014,-113.46871,{"facility":13,"city":149,"state":150,"zip":151,"country":139,"contacts":152,"geoPoint":162},"Toronto","Ontario","M5G 1X8",[153,157,161],{"name":154,"role":105,"phone":155,"email":156},"Ann Yeh, MD","416-813-7353","ann.yeh@sickkids.ca",{"name":158,"role":105,"phone":159,"email":160},"Jesse Joynt, MSc","416-813-7654 X415125","jesse.joynt@sickkids.ca",{"name":154,"role":113},{"lat":163,"lon":164},43.70643,-79.39864,[166,167],{"name":154,"role":105,"phone":155,"email":156},{"name":158,"role":105,"phone":159,"email":160},[],[170,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216],{"pmid":171,"type":172,"citation":173},"29275977","RESULT","Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016\u002FS1474-4422(17)30470-2. Epub 2017 Dec 21.",{"pmid":175,"type":172,"citation":176},"21387374","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\u002Fana.22366.",{"pmid":178,"type":172,"citation":179},"17438241","Krupp LB, Banwell B, Tenembaum S; International Pediatric MS Study Group. Consensus definitions proposed for pediatric multiple sclerosis and related disorders. Neurology. 2007 Apr 17;68(16 Suppl 2):S7-12. doi: 10.1212\u002F01.wnl.0000259422.44235.a8.",{"pmid":181,"type":172,"citation":182},"34954651","Stephens S, Schneiderman JE, Finlayson M, Berenbaum T, Motl RW, Yeh EA. Feasibility of a theory-informed mobile app for changing physical activity in youth with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103467. doi: 10.1016\u002Fj.msard.2021.103467. Epub 2021 Dec 20.",{"pmid":184,"type":172,"citation":185},"31022481","Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016\u002Fj.cct.2019.04.013. Epub 2019 Apr 22.",{"pmid":187,"type":172,"citation":188},"33245672","Stephens S, Berenbaum T, Finlayson M, Motl RW, Yeh EA. Youth with multiple sclerosis have low levels of fitness. Mult Scler. 2021 Sep;27(10):1597-1605. doi: 10.1177\u002F1352458520974360. Epub 2020 Nov 27.",{"pmid":190,"type":172,"citation":191},"35349884","Bilek F, Cetisli-Korkmaz N, Ercan Z, Deniz G, Demir CF. Aerobic exercise increases irisin serum levels and improves depression and fatigue in patients with relapsing remitting multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2022 May;61:103742. doi: 10.1016\u002Fj.msard.2022.103742. Epub 2022 Mar 15.",{"pmid":193,"type":172,"citation":194},"23800444","Spalletta G, Piras F, Caltagirone C, Fagioli S. Hippocampal multimodal structural changes and subclinical depression in healthy individuals. J Affect Disord. 2014 Jan;152-154:105-12. doi: 10.1016\u002Fj.jad.2013.05.068. Epub 2013 Jun 22.",{"pmid":196,"type":172,"citation":197},"16126743","Nabkasorn C, Miyai N, Sootmongkol A, Junprasert S, Yamamoto H, Arita M, Miyashita K. Effects of physical exercise on depression, neuroendocrine stress hormones and physiological fitness in adolescent females with depressive symptoms. Eur J Public Health. 2006 Apr;16(2):179-84. doi: 10.1093\u002Feurpub\u002Fcki159. Epub 2005 Aug 26.",{"pmid":199,"type":172,"citation":200},"24120943","Wrann CD, White JP, Salogiannnis J, Laznik-Bogoslavski D, Wu J, Ma D, Lin JD, Greenberg ME, Spiegelman BM. Exercise induces hippocampal BDNF through a PGC-1alpha\u002FFNDC5 pathway. Cell Metab. 2013 Nov 5;18(5):649-59. doi: 10.1016\u002Fj.cmet.2013.09.008. Epub 2013 Oct 10.",{"pmid":202,"type":172,"citation":203},"17765329","Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016\u002Fj.tins.2007.06.011. Epub 2007 Aug 31.",{"pmid":205,"type":172,"citation":206},"21282661","Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073\u002Fpnas.1015950108. Epub 2011 Jan 31.",{"pmid":208,"type":172,"citation":209},"22805247","Parrish JB, Weinstock-Guttman B, Smerbeck A, Benedict RH, Yeh EA. Fatigue and depression in children with demyelinating disorders. J Child Neurol. 2013 Jun;28(6):713-8. doi: 10.1177\u002F0883073812450750. Epub 2012 Jul 17.",{"pmid":211,"type":172,"citation":212},"30211252","Longoni G, Brown RA, Aubert-Broche B, Grover SA, Branson HM, Fetco D, Bar-Or A, Marrie RA, Motl RW, Collins DL, Narayanan S, Arnold DL, Banwell B, Yeh EA. Physical activity and dentate gyrus volume in pediatric acquired demyelinating syndromes. Neurol Neuroimmunol Neuroinflamm. 2018 Sep 6;5(6):e499. doi: 10.1212\u002FNXI.0000000000000499. eCollection 2018 Nov.",{"pmid":214,"type":172,"citation":215},"27717498","Grover SA, Sawicki CP, Kinnett-Hopkins D, Finlayson M, Schneiderman JE, Banwell B, Till C, Motl RW, Yeh EA. Physical Activity and Its Correlates in Youth with Multiple Sclerosis. J Pediatr. 2016 Dec;179:197-203.e2. doi: 10.1016\u002Fj.jpeds.2016.08.104. Epub 2016 Oct 4.",{"pmid":217,"type":172,"citation":218},"30878208","Stephens S, Shams S, Lee J, Grover SA, Longoni G, Berenbaum T, Finlayson M, Motl RW, Yeh EA. Benefits of Physical Activity for Depression and Fatigue in Multiple Sclerosis: A Longitudinal Analysis. J Pediatr. 2019 Jun;209:226-232.e2. doi: 10.1016\u002Fj.jpeds.2019.01.040. Epub 2019 Mar 14.",[],{"nct_id":4,"conditions":221,"biomarkers":223},[222,20],"Clinically isolated syndrome",[],{"nct_id":4,"found":225,"summary":226,"prompt_version":236},true,{"design":227,"status":228,"heading":229,"summary":230,"follow_up":231,"word_count":232,"commitments":233,"compensation":234,"drugs_mentioned":235},"This is a randomized controlled feasibility trial involving about 40 participants. Participants will be assigned by chance to one of two groups.","completed","FIT-ATOMIC Exercise Feasibility Trial for Youth with MS","This study is looking at whether a home-based exercise program is a good way to help young people (ages 11-25) with Multiple Sclerosis (MS) or clinically isolated syndrome. We want to see if it's possible to do a larger study on exercise as a way to improve health for this group. Participants will be randomly assigned to either an Exercise Training group or a Mobility and Flexibility Training group for 20 weeks. We will compare how these groups affect physical activity, mental well-being, and other health measures. The main goals are to see how many people join, how well the exercise program is delivered, and how many people complete the study.","The study measures participant drop-out rate from enrollment to the end of the study, which is 20 weeks after the intervention begins.",111,"You would participate in three weekly exercise sessions for 20 weeks. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will happen at the beginning and after 20 weeks.","Not stated in the trial record.",[46,53],"v2"]