[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07698197":3,"trial-entities:NCT07698197":103,"trial-summary:NCT07698197":109},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":71,"locations":74,"central_contacts":91,"overall_officials":98,"references":101,"see_also_links":102},"NCT07698197","2000042319","Exercise Intervention and Immunodeficiency","Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study","RECRUITING","2027-07","2026-07","2026-07-23","2026-07-17","Yale University","OTHER",null,"The purpose of this study is to assess if a 12-week exercise program is safe, practical, and acceptable for adults with primary antibody deficiencies. It also looks at whether the program can improve the quality of life and help the immune system work better.","Study activities will include:\n\nCompletion of health questionnaires Participation in a 12-week exercise program using a mobile application Having your exercise activity tracked through the mobile application Reporting any symptoms or infections that develop Providing blood samples for immune-related testing at your patient visits. Completion of assessments at the beginning and end of study",[19],"Primary Antibody Deficiency Disorders",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},20,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","App-based exercise intervention","12 week structured moderate-intensity exercise intervention delivered via a mobile application",[31],[35,39,43,46,49,52],{"measure":36,"description":37,"timeFrame":38},"Recruitment rate","Number and proportion of eligible individuals who enroll","Day 1",{"measure":40,"description":41,"timeFrame":42},"Retention rate","Number of enrolled participants who complete the 12-week study","12 weeks",{"measure":44,"description":45,"timeFrame":42},"Frequency of app usage- Adherence","Mean number of times app was utilized",{"measure":47,"description":48,"timeFrame":42},"Duration of workout- Adherence","Mean duration of workout in minutes",{"measure":50,"description":51,"timeFrame":42},"Mean score Borg Scale of Rating of Perceived Exertion","Measures exertion on a total scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).",{"measure":53,"description":54,"timeFrame":42},"Data completeness","Proportion of expected study data successfully collected at each time point",[],"ALL","18 Years","65 Years",false,{"inclusion":61,"exclusion":65,"raw_text":70},[62,63,64],"Diagnosed with one of the following primary antibody deficiencies: IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency","Receiving care in the Section of Rheumatology, Allergy \\& Immunology","Able and willing to participate in a moderate-intensity exercise program. Patients will be screened using the American College of Sports Medicine (ACSM) Pre- participation Screening Guidelines. This algorithm assesses patients for cardiovascular, renal, and metabolic disease. Those patients determined to not require further medical clearance to participate in exercise will be included.",[66,67,68,69],"Receipt of immunoglobulin (Ig) replacement therapy","Use of immunosuppressive or immunomodulatory medications (e.g., chronic systemic corticosteroids, B-cell-depleting therapies)","Medical contraindications to moderate-intensity exercise as determined by clinical assessment using the previously discussed ACSM Pre-participation Screening Guidelines.","Other risk factors\u002Fmedical conditions that would limit safe participation in exercise as determined by clinical assessment, including active rheumatologic conditions including active rheumatoid arthritis.","Inclusion Criteria:\n\n* Diagnosed with one of the following primary antibody deficiencies: IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency\n* Receiving care in the Section of Rheumatology, Allergy \\& Immunology\n* Able and willing to participate in a moderate-intensity exercise program. Patients will be screened using the American College of Sports Medicine (ACSM) Pre- participation Screening Guidelines. This algorithm assesses patients for cardiovascular, renal, and metabolic disease. Those patients determined to not require further medical clearance to participate in exercise will be included.\n\nExclusion Criteria:\n\n* Receipt of immunoglobulin (Ig) replacement therapy\n* Use of immunosuppressive or immunomodulatory medications (e.g., chronic systemic corticosteroids, B-cell-depleting therapies)\n* Medical contraindications to moderate-intensity exercise as determined by clinical assessment using the previously discussed ACSM Pre-participation Screening Guidelines.\n* Other risk factors\u002Fmedical conditions that would limit safe participation in exercise as determined by clinical assessment, including active rheumatologic conditions including active rheumatoid arthritis.",[72,73],"ADULT","OLDER_ADULT",[75,84],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"Bridgeport Hospital","Milford","Connecticut","06460","United States",{"lat":82,"lon":83},41.22232,-73.0565,{"facility":85,"status":8,"city":86,"state":78,"zip":87,"country":80,"geoPoint":88},"Yale New Haven Health","North Haven","06473",{"lat":89,"lon":90},41.39093,-72.85954,[92],{"name":93,"role":94,"phone":95,"phoneExt":96,"email":97},"Ryan Steele, DO, MSc","CONTACT","203-785-7092","57092","r.steele@yale.edu",[99],{"name":93,"affiliation":13,"role":100},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":108},[105,106,107],"Immunoglobulin G subclass deficiency","Selective IgE Immunodeficiency","Specific antibody deficiency",[],{"nct_id":4,"found":110,"summary":111,"prompt_version":121},true,{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an interventional study with a planned enrollment of 20 participants. The phase of the study is not specified.","completed","Exercise Intervention for Primary Antibody Deficiency Disorders","This study is testing an App-based exercise intervention, a 12-week structured moderate-intensity exercise program delivered through a mobile app. It aims to see if this program is safe, practical, and acceptable for adults with primary antibody deficiency disorders (conditions where your body doesn't make enough antibodies to fight infections). The study also wants to find out if the program can improve your quality of life and help your immune system work better. You can join if you are 18 to 65 years old, have a diagnosed primary antibody deficiency (like IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency), are receiving care in the Section of Rheumatology, Allergy & Immunology, and are willing to do moderate exercise. The study will measure how many people join, how many stay in the study for 12 weeks, and how often they use the app. The current recruitment status is unclear.","The study measures retention and app usage at 12 weeks.",151,"You will complete health questionnaires, participate in a 12-week exercise program using a mobile app, have your exercise activity tracked, report symptoms or infections, and provide blood samples at patient visits. Assessments will be done at the beginning and end of the study.","Not stated in the trial record.",[31],"v2"]