Recruiting

Exercise Program

Sponsor:

Yale University

Code:

NCT07698197

Conditions

Primary Antibody Deficiency Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

App-based exercise intervention

Study Details

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.

Conditions

Primary Antibody Deficiency Disorders

Study ID

NCT07698197

Start date

Jul 17, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

App-based exercise intervention

12 week structured moderate-intensity exercise intervention delivered via a mobile application

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ryan Steele, DO, MSc

203-785-7092r.steele@yale.edu

Locations

Bridgeport Hospital

Recruiting

Milford, Connecticut, United States, 06460

Yale New Haven Health

Recruiting

North Haven, Connecticut, United States, 06473

More Information

Sponsor

Yale University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-23.