Exercise Intervention and Immunodeficiency
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
App-based exercise intervention
Behavioral12 week structured moderate-intensity exercise intervention delivered via a mobile application
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: App-based exercise interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Number and proportion of eligible individuals who enroll
Time frame
Day 12
Retention rate
Number of enrolled participants who complete the 12-week study
Time frame
12 weeks3
Frequency of app usage- Adherence
Mean number of times app was utilized
Time frame
12 weeks4
Duration of workout- Adherence
Mean duration of workout in minutes
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
The Pump
Collaborator
Source ClinicalTrials.gov
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