Primary Antibody Deficiency DisordersNCT07698197
Exercise Intervention and Immunodeficiency
A study testing App-based exercise intervention in people with Primary Antibody Deficiency Disorders, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Antibody Deficiency Disorders
- What is being tested?
- App-based exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Bridgeport Hospital
Milford, Connecticut, 06460
- Recruiting
Yale New Haven Health
North Haven, Connecticut, 06473
About this study
Official title: Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study
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.
Read the 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
- Conditions
- Primary Antibody Deficiency Disorders
- Being tested
- App-based exercise intervention
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based exercise interventionBehavioural
12 week structured moderate-intensity exercise intervention delivered via a mobile application
| Study group | Role | What they receive |
|---|---|---|
| App-based exercise intervention | Experimental | 12-week, app-based exercise intervention in adults with primary antibody deficiencies with completion of survey procedures and collection of clinical and laboratory data Receives: Behavioral: App-based exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number and proportion of eligible individuals who enroll
Measured: Day 1
Retention rate
Number of enrolled participants who complete the 12-week study
Measured: 12 weeks
Frequency of app usage- Adherence
Mean number of times app was utilized
Measured: 12 weeks
Duration of workout- Adherence
Mean duration of workout in minutes
Measured: 12 weeks
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).
Measured: 12 weeks
Data completeness
Proportion of expected study data successfully collected at each time point
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start17 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Antibody Deficiency DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- The Pump
- Responsible party
- Sponsor
- Investigators
- Ryan Steele, DO, MSc, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698197
- Sponsor's protocol ID
- 2000042319
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study
- ClinicalTrials.gov ID
- NCT07698197
- Acronym / sponsor ID
- 2000042319
- Conditions
- Primary Antibody Deficiency Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- The Pump
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App-based exercise intervention | Experimental | Behavioral: App-based exercise intervention12-week, app-based exercise intervention in adults with primary antibody deficiencies with completion of survey procedures and collection of clinical and laboratory data |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based exercise intervention12 week structured moderate-intensity exercise intervention delivered via a mobile application | Behavioural | App-based exercise intervention |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Antibody Deficiency Disorders
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
RecruitingPhase 2
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
Primary T-cell Immunodeficiency Disorders, Common Variable Immunodeficiency
RecruitingObservational study
Immune Regulation in Patients With Common Variable Immunodeficiency and Related Inborn Errors of Immunity (IEI)
XLA, CVID
RecruitingPhase 2
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
Lymphoproliferative Disorders, Autoimmune Lymphoproliferative
RecruitingPhase 2
Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
Multiple Myeloma, Hypogammaglobulinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Steele, DO, MSc principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based exercise intervention in people with Primary Antibody Deficiency Disorders, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Steele, DO, MSc (203-785-7092 ext. 57092, r.steele@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.