Exercise Intervention and Immunodeficiency

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Antibody Deficiency Disorders
• Intervention / Treatment: Behavioral: App-based exercise intervention

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Steele, DO, MSc; Phone Number: 57092 203-785-7092; Email: r.steele@yale.edu

Study Locations

• United States
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Bridgeport Hospital
    • North Haven, Connecticut, United States, 06473
      • Yale New Haven Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: App-based exercise intervention; 12 week structured moderate-intensity exercise intervention delivered via a mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Number and proportion of eligible individuals who enroll	Day 1
Retention rate	Number of enrolled participants who complete the 12-week study	12 weeks
Frequency of app usage- Adherence	Mean number of times app was utilized	12 weeks
Duration of workout- Adherence	Mean duration of workout in minutes	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).	12 weeks
Data completeness	Proportion of expected study data successfully collected at each time point	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: The Pump
• Investigators: Principal Investigator: Ryan Steele, DO, MSc, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Immunologic Deficiency Syndromes; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases
• Other Study ID Numbers: 2000042319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No