Primary Antibody Deficiency Disorders
Conditions
Brief summary
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
BEHAVIORALApp-based exercise intervention
12 week structured moderate-intensity exercise intervention delivered via a mobile application
Sponsors
Yale University
The Pump
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Day 1 | Number and proportion of eligible individuals who enroll |
| Retention rate | 12 weeks | Number of enrolled participants who complete the 12-week study |
| Frequency of app usage- Adherence | 12 weeks | Mean number of times app was utilized |
| Duration of workout- Adherence | 12 weeks | Mean duration of workout in minutes |
| Mean score Borg Scale of Rating of Perceived Exertion | 12 weeks | Measures exertion on a total scale of 0 (no exertion or resting) to 10 (pushing yourself to the max). |
| Data completeness | 12 weeks | Proportion of expected study data successfully collected at each time point |
Countries
United States
Contacts
CONTACTRyan Steele, DO, MSc
PRINCIPAL_INVESTIGATORRyan Steele, DO, MSc
Yale University
Outcome results
None listed