Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Recruitment rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
App-based exercise intervention
12-week, app-based exercise intervention in adults with primary antibody deficiencies with completion of survey procedures and collection of clinical and laboratory data
Intervention: App-based exercise intervention (Behavioral)
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: Day 1
Number and proportion of eligible individuals who enroll
Retention rate
Time Frame: 12 weeks
Number of enrolled participants who complete the 12-week study
Frequency of app usage- Adherence
Time Frame: 12 weeks
Mean number of times app was utilized
Duration of workout- Adherence
Time Frame: 12 weeks
Mean duration of workout in minutes
Mean score Borg Scale of Rating of Perceived Exertion
Time Frame: 12 weeks
Measures exertion on a total scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).
Data completeness
Time Frame: 12 weeks
Proportion of expected study data successfully collected at each time point
Secondary Outcomes
No secondary outcomes reported