Exercise Intervention and Immunodeficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: App-based exercise intervention.
- Who it may be relevant to
- Registry conditions: Primary Antibody Deficiency Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study
Overview
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.
Detailed description
Study activities will include:
Completion 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
Interventions
- Behavioral App-based exercise intervention
12 week structured moderate-intensity exercise intervention delivered via a mobile application
Primary outcome measures
- Recruitment rate [Time frame: Day 1]
- Retention rate [Time frame: 12 weeks]
- Frequency of app usage- Adherence [Time frame: 12 weeks]
- Duration of workout- Adherence [Time frame: 12 weeks]
- Mean score Borg Scale of Rating of Perceived Exertion [Time frame: 12 weeks]
- Data completeness [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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/medical conditions that would limit safe participation in exercise as determined by clinical assessment, including active rheumatologic conditions including active rheumatoid arthritis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Bridgeport Hospital — Milford
- Yale New Haven Health — North Haven
Identifiers
NCT: NCT07698197 · 2000042319