[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06880653":3,"trial-entities:NCT06880653":122,"trial-summary:NCT06880653":128},{"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":25,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":45,"secondary_outcomes":50,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":15,"eligibility_criteria":77,"std_ages":93,"locations":96,"central_contacts":111,"overall_officials":116,"references":120,"see_also_links":121},"NCT06880653","Pro00140006","Dose Response of Exercise for Arthritis Management","Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes","RECRUITING","2029-04-30","2026-04","2026-04-03","2025-03-28","University of South Carolina","OTHER",false,"The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes\u002Fweek, 90 minutes\u002Fweek, or 150 minutes\u002Fweek) on arthritis symptoms.","All participants will be randomly assigned a physical activity goal (45 min\u002Fweek, 90 min\u002Fweek, or 150 min\u002Fweek). To help participants achieve goals, they will receive a 6 month program which includes the Arthritis Foundation's Walk With Ease Guidebook, behavioral lessons, a Fitbit, and monthly coaching calls. Participants may also receive additional calls, texts, or emails if they are struggling to meet their physical activity goals.",[19,20,21,22,23,24],"Arthritis","Rheumatoid Arthritis (RA)","Gout","Fibromyalgia (FM)","Osteoarthritis","Lupus Erythematosus, Systemic",[26,27,28],"arthritis","exercise","physical activity","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},285,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","DREAM Adaptive Intervention","6-month physical activity program (Dose Response of Exercise for Arthritis Management (DREAM)) which includes monthly phone coaching, Walk With Ease Guidebook, behavioral lessons, and a Fitbit. Participants may receive additional contact (email, text, or phone) if they struggle to meet activity goal.",[42,43,44],"150 minutes\u002Fweek","45 minutes\u002Fweek","90 minutes\u002Fweek",[46],{"measure":47,"description":48,"timeFrame":49},"Physical function (6 Minute Walk Test)","Change in distance walked during the 6 minute walk test","Baseline to 6 months",[51,53,56,57,60,61,64,65,68,69,72],{"measure":47,"description":48,"timeFrame":52},"Baseline to 12 months",{"measure":54,"description":55,"timeFrame":49},"Physical function (chair stands)","Change in chair stand repetitions",{"measure":54,"description":55,"timeFrame":52},{"measure":58,"description":59,"timeFrame":49},"Health Related Quality of Life - Physical","Change in the physical component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.",{"measure":58,"description":59,"timeFrame":52},{"measure":62,"description":63,"timeFrame":49},"Health Related Quality of Life - Mental","Change in the mental component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.",{"measure":62,"description":63,"timeFrame":52},{"measure":66,"description":67,"timeFrame":49},"Pain intensity","Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.",{"measure":66,"description":67,"timeFrame":52},{"measure":70,"description":71,"timeFrame":49},"Depression symptoms","Change in depression symptoms using the CES-D. Scores range from 0-60, with higher scores reflective of more depression symptoms.",{"measure":70,"description":73,"timeFrame":52},"Change in depression symptoms using the CES-D. Change in depression symptoms using the CES-D. Scores range from 0-60, with higher scores reflective of more depression symptoms.","ALL","18 Years",null,{"inclusion":78,"exclusion":82,"raw_text":92},[79,80,81],"18 years or older","Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia","Ability to read and write in English",[83,84,85,86,87,88,89,90,91],"Have any contraindications to exercise (besides arthritis)","Engage in \\>45 min\u002Fweek of Actigraph assessed moderate to vigorous intensity activity","Are pregnant, breastfeeding, or planning to become pregnant in the next year","Are planning to relocate out of the Columbia, SC area in the next 12 months,","Do not have a device compatible with Fitbit","Have uncontrolled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg)","Plan to have a surgery that affects mobility in the next 12 months","Have a serious cognitive impairment.","Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes\u002Fweek).","Inclusion Criteria:\n\n* 18 years or older\n* Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have any contraindications to exercise (besides arthritis)\n* Engage in \\>45 min\u002Fweek of Actigraph assessed moderate to vigorous intensity activity\n* Are pregnant, breastfeeding, or planning to become pregnant in the next year\n* Are planning to relocate out of the Columbia, SC area in the next 12 months,\n* Do not have a device compatible with Fitbit\n* Have uncontrolled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg)\n* Plan to have a surgery that affects mobility in the next 12 months\n* Have a serious cognitive impairment.\n* Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes\u002Fweek).",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":13,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"Columbia","South Carolina","29208","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Christine Pellegrini","CONTACT","803-777-0911","pellegca@mailbox.sc.edu",{"lat":109,"lon":110},34.00071,-81.03481,[112],{"name":113,"role":105,"phone":114,"email":115},"Ellen Wingard","803-777-1889","EWINGARD@mailbox.sc.edu",[117],{"name":118,"affiliation":13,"role":119},"Christine Pellegrini, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":123,"biomarkers":127},[19,124,21,23,125,126],"Fibromyalgia","Rheumatoid Arthritis","Systemic Lupus Erythematosus",[],{"nct_id":4,"found":129,"summary":130,"prompt_version":139},true,{"design":131,"status":132,"heading":6,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is an interventional study where participants are randomly assigned to one of three physical activity goals. It plans to enroll 285 participants.","completed","This study is looking at how different amounts of physical activity can help manage symptoms for people with arthritis, rheumatoid arthritis (RA), gout, fibromyalgia (FM), or osteoarthritis. You would be assigned to one of three physical activity goals (45, 90, or 150 minutes per week) and receive a 6-month program called DREAM Adaptive Intervention. This program includes monthly phone coaching, a Walk With Ease Guidebook, behavioral lessons, and a Fitbit to help you reach your goals. The study will measure your physical function using a 6 Minute Walk Test to see if the exercise program helps. This study is currently recruiting and aims to enroll 285 participants who are 18 or older, have a doctor-diagnosed form of arthritis, and can read and write in English.","Your physical function will be measured at the start of the study and again at 6 months.",125,"You would participate in a 6-month physical activity program, including monthly phone coaching and using a Fitbit. Your physical function will be measured at the beginning and after 6 months.","Not stated in the trial record.",[39],"v2"]